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    Clinical Trial Results:
    A Phase IIIB, Randomized, Open Label, Feasibility Study of a Single Priming Dose of Meningococcal Group C Conjugate Vaccine (NeisVac-C) in Infants

    Summary
    EudraCT number
    		 2010-019383-36
    Trial protocol
    		 PL   ES  
    Global end of trial date
    31 Jan 2012

    Results information
    Results version number
    		 v2(current)
    This version publication date
    16 Dec 2021
    First version publication date
    05 Aug 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    reporting periods and duplicate AEs in their data

    Trial information

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    Trial identification
    Sponsor protocol code
    670901
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01218451
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Alias: B9361011
    Sponsors
    Sponsor organisation name
    Pfizer Inc.
    Sponsor organisation address
    235 E 42nd Street, New York, United States, NY 10017
    Public contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 800-718-1021, ClinicalTrails.gov_Inquiries@pfizer.com
    Scientific contact
    Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc., 001 800-718-1021, ClinicalTrails.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
    27 Jul 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Jan 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the feasibility of a single priming dose of NeisVac-C in infants (at either 4 or 6 months of age), as determined by immune response.
    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
    28 Sep 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Poland: 835
    Country: Number of subjects enrolled
    Spain: 111
    Worldwide total number of subjects
    946
    EEA total number of subjects
    946
    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)
    946
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Study was conducted in Poland and Spain. Study was initiated on 28 Sep 2010 and completed on 31 Jan 2012.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 NeisVac-C: Group 1
    Arm description
    		 Subjects recieved single dose of NeisVac-C at 4 months of age along with Infanrix hexa and Prevenar 13 at 2, 4 and 6 months of age, and booster vaccination of all the vaccines between the age of 12 and 13 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    NeisVac-C
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    A single 0.5 millilitre (mL) dose at 4 months of age, with booster vaccinations between 12 and 13 months of age.

    Investigational medicinal product name
    Infanrix hexa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL Infanrix hexa at 2, 4 and 6 months of age, with booster vaccinations between 12 and 13 months of age.

    Investigational medicinal product name
    Prevenar 13
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL Prevenar 13 at 2, 4 and 6 months of age, with booster vaccinations between 12 and 13 months of age.

    Arm title
    		 NeisVac-C: Group 2
    Arm description
    		 Subjects recieved single dose of NeisVac-C at 6 months of age along with Infanrix hexa and Prevenar 13 at 2, 4 and 6 months of age, and booster vaccination of all the vaccines between the age of 12 and 13 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    NeisVac-C
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    A single 0.5mL dose at 6 months of age with booster vaccination between 12 and 13 months of age.

    Investigational medicinal product name
    Infanrix hexa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL Infanrix hexa at 2, 4 and 6 months of age, with booster vaccinations between 12 and 13 months of age.

    Investigational medicinal product name
    Prevenar 13
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL Prevenar 13 at 2, 4 and 6 months of age, with booster vaccinations between 12 and 13 months of age.

    Arm title
    		 NeisVac-C: Group 3
    Arm description
    		 Subjects received two doses of NeisVac-C one each at 2 and 4 months of age along with Infanrix hexa and Prevenar 13 at 2, 4 and 6 months of age, with booster vaccinations of all the vaccines between 12 and 13 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    NeisVac-C
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    A single 0.5mL dose at either 2 or 4 month of age with booster vaccination between 12 and 13 months of age.

    Investigational medicinal product name
    Infanrix hexa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL Infanrix hexa at 2, 4 and 6 months of age, with booster vaccinations between 12 and 13 months of age.

    Investigational medicinal product name
    Prevenar 13
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL Prevenar 13 at 2, 4 and 6 months of age, with booster vaccinations between 12 and 13 months of age.

    Number of subjects in period 1 [1]
    		NeisVac-C: Group 1 NeisVac-C: Group 2 NeisVac-C: Group 3
    Started
    318
    312
    315
    Completed
    307
    300
    297
    Not completed
    11
    12
    18
         Consent withdrawn by subject
    1
    4
    9
         Adverse event
    3
    1
    2
         Unspecified
    7
    2
    3
         Lost to follow-up
    -
    5
    4
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: One subject was excluded from the safety analysis data set because NeisVac-C vaccinations were administered at Months 2, 4 and 6.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    NeisVac-C: Group 1
    Reporting group description
    		 Subjects recieved single dose of NeisVac-C at 4 months of age along with Infanrix hexa and Prevenar 13 at 2, 4 and 6 months of age, and booster vaccination of all the vaccines between the age of 12 and 13 months.

    Reporting group title
    NeisVac-C: Group 2
    Reporting group description
    		 Subjects recieved single dose of NeisVac-C at 6 months of age along with Infanrix hexa and Prevenar 13 at 2, 4 and 6 months of age, and booster vaccination of all the vaccines between the age of 12 and 13 months.

    Reporting group title
    NeisVac-C: Group 3
    Reporting group description
    		 Subjects received two doses of NeisVac-C one each at 2 and 4 months of age along with Infanrix hexa and Prevenar 13 at 2, 4 and 6 months of age, with booster vaccinations of all the vaccines between 12 and 13 months of age.

    Reporting group values
    		 NeisVac-C: Group 1 NeisVac-C: Group 2 NeisVac-C: Group 3 Total
    Number of subjects
    		 318 312 315 945
    Age categorical
    Units: Subjects
    Age continuous
    Units: weeks
        arithmetic mean (standard deviation)
    		 7.7 ( 1.49 ) 7.6 ( 1.45 ) 7.7 ( 1.45 ) -
    Gender categorical
    Units: Subjects
        Female
    		 145 145 158 448
        Male
    		 173 167 157 497

    End points

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    End points reporting groups
    Reporting group title
    NeisVac-C: Group 1
    Reporting group description
    		 Subjects recieved single dose of NeisVac-C at 4 months of age along with Infanrix hexa and Prevenar 13 at 2, 4 and 6 months of age, and booster vaccination of all the vaccines between the age of 12 and 13 months.

    Reporting group title
    NeisVac-C: Group 2
    Reporting group description
    		 Subjects recieved single dose of NeisVac-C at 6 months of age along with Infanrix hexa and Prevenar 13 at 2, 4 and 6 months of age, and booster vaccination of all the vaccines between the age of 12 and 13 months.

    Reporting group title
    NeisVac-C: Group 3
    Reporting group description
    		 Subjects received two doses of NeisVac-C one each at 2 and 4 months of age along with Infanrix hexa and Prevenar 13 at 2, 4 and 6 months of age, with booster vaccinations of all the vaccines between 12 and 13 months of age.

    Primary: Proportion of Subjects With Seroprotective Antibody Titers 1 Month After Completion of the Primary Vaccination

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    End point title
    		 Proportion of Subjects With Seroprotective Antibody Titers 1 Month After Completion of the Primary Vaccination
    End point description
    Number of subjects achieving seroprotective antibody titre (Serum bactericidal activity [rSBA] greater than or equal to [>=] 8), 1 month after the primary vaccination of NeisVac-C was reported. Per protocol analysis data set contained all randomized and vaccinated subjects who fulfilled the exclusion/inclusion criteria, had no major protocol deviation affecting the estimate of treatment effect and had immunogenicity measurements available for at least one of the three co-primary endpoints.
    End point type
    Primary
    End point timeframe
    1 month after primary vaccination
    End point values
    		 NeisVac-C: Group 1 NeisVac-C: Group 2 NeisVac-C: Group 3
    Number of subjects analysed
    271
    265
    250
    Units: Proportion of subjects
        number (confidence interval 90%)
    99.6 (98.3 to 100)
    99.2 (97.6 to 99.9)
    99.6 (98.1 to 100)
    Statistical analysis title
    		 Response Rate (Group 2 vs Group 3)
    Statistical analysis description
    Non-inferiority margin was set to -10%. 90% Confidence Interval (CI) for the difference in the proportion of subjects with rSBA >= 8 was calculated between Group 2 and Group 3.
    Comparison groups
    NeisVac-C: Group 3 v NeisVac-C: Group 2
    Number of subjects included in analysis
    515
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in proportion
    Point estimate
    -0.4
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -1.9
         upper limit
    		 1.1
    Statistical analysis title
    		 Response Rate (Group 1 vs Group 3)
    Statistical analysis description
    Non-inferiority margin was set to -10%. 90% CI for the difference in the proportion of subjects with rSBA >= 8 was calculated between Group 1 and Group 3.
    Comparison groups
    NeisVac-C: Group 1 v NeisVac-C: Group 3
    Number of subjects included in analysis
    521
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 1.4

    Primary: Proportion of Subjects With Seroprotective Antibody Titers Prior to the Administration of the Booster Dose

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    End point title
    		 Proportion of Subjects With Seroprotective Antibody Titers Prior to the Administration of the Booster Dose
    End point description
    Number of subjects achieving seroprotective antibody titre (rSBA >= 8) prior to the administration of the booster vaccination of NeisVac-C was reported. Per protocol analysis data set contained all randomized and vaccinated subjects who fulfilled the exclusion/inclusion criteria, had no major protocol deviation affecting the estimate of treatment effect and had immunogenicity measurements available for at least one of the three co-primary endpoints.
    End point type
    Primary
    End point timeframe
    Before Booster Dose
    End point values
    		 NeisVac-C: Group 1 NeisVac-C: Group 2 NeisVac-C: Group 3
    Number of subjects analysed
    264 [1]
    258 [2]
    245 [3]
    Units: Proportion of subjects
        number (confidence interval 90%)
    78 (73.4 to 82.2)
    90.7 (87.2 to 93.5)
    67.8 (62.5 to 72.7)
    Notes
    [1] - Number of subjects evaluable for this endpoint.
    [2] - Number of subjects evaluable for this endpoint.
    [3] - Number of subjects evaluable for this endpoint.
    Statistical analysis title
    		 Response Rate (Group 2 vs Group 3)
    Statistical analysis description
    Non-inferiority margin was set to -10%. 90% CI for the difference in the proportion of subjects with rSBA >= 8 was calculated between Group 2 and Group 3.
    Comparison groups
    NeisVac-C: Group 2 v NeisVac-C: Group 3
    Number of subjects included in analysis
    503
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in proportion
    Point estimate
    22.9
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 17.2
         upper limit
    		 28.7
    Statistical analysis title
    		 Response Rate (Group 1 vs Group 3)
    Statistical analysis description
    Non-inferiority margin was set to -10%. 90% CI for the difference in the proportion of subjects with rSBA >= 8 was calculated between Group 1 and Group 3.
    Comparison groups
    NeisVac-C: Group 1 v NeisVac-C: Group 3
    Number of subjects included in analysis
    509
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in proportion
    Point estimate
    10.3
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 3.8
         upper limit
    		 16.7

    Primary: Proportion of Subjects With Seroprotective Antibody Titers 1 Month After the Administration of the Booster Dose.

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    End point title
    		 Proportion of Subjects With Seroprotective Antibody Titers 1 Month After the Administration of the Booster Dose.
    End point description
    Number of subjects achieving seroprotective antibody titre (rSBA >= 128), 1 month after the administration of booster vaccination of NeisVac-C was reported.The per protocol analysis data set contained all randomized and vaccinated subjects who fulfilled the exclusion/inclusion criteria, had no major protocol deviation affecting the estimate of treatment effect and had immunogenicity measurements available for at least one of the three co-primary endpoints.
    End point type
    Primary
    End point timeframe
    1 month after booster dose
    End point values
    		 NeisVac-C: Group 1 NeisVac-C: Group 2 NeisVac-C: Group 3
    Number of subjects analysed
    264 [4]
    258 [5]
    243 [6]
    Units: Proportion of subjects
        number (confidence interval 90%)
    98.9 (97.1 to 99.7)
    99.6 (98.2 to 100)
    99.6 (98.1 to 100)
    Notes
    [4] - Number of subjects evaluable for this endpoint.
    [5] - Number of subjects evaluable for this endpoint.
    [6] - Number of subjects evaluable for this endpoint.
    Statistical analysis title
    		 Response Rate (Group 2 vs Group 3)
    Statistical analysis description
    Non-inferiority margin was set to -5%. 90% CI for the difference in the proportion of subjects with rSBA >= 128 was calculated between Group 2 and Group 3.
    Comparison groups
    NeisVac-C: Group 2 v NeisVac-C: Group 3
    Number of subjects included in analysis
    501
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in proportion
    Point estimate
    0
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 1.5
    Statistical analysis title
    		 Response Rate (Group 1 vs Group 3)
    Statistical analysis description
    Non-inferiority margin was set to -5%. 90% CI for the difference in the proportion of subjects with rSBA >= 128 was calculated between Group 1 and Group 3.
    Comparison groups
    NeisVac-C: Group 1 v NeisVac-C: Group 3
    Number of subjects included in analysis
    507
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in proportion
    Point estimate
    -0.7
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 -2.5
         upper limit
    		 0.8

    Secondary: Geometric Mean Titer for Serum Bactericidal Activity (rSBA) 1 Month After Completion of the Primary Vaccination

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    End point title
    		 Geometric Mean Titer for Serum Bactericidal Activity (rSBA) 1 Month After Completion of the Primary Vaccination
    End point description
    rSBA titer 1 month after primary vaccination with NeisVac-C was reported. The immunogenicity analysis data set contained all randomized and vaccinated subjects (at least one vaccination with NeisVac-C) with available data for the immunogenicity analysis, i.e. with both baseline and at least one post-baseline immunogenicity measurement available.
    End point type
    Secondary
    End point timeframe
    1 month after primary vaccination
    End point values
    		 NeisVac-C: Group 1 NeisVac-C: Group 2 NeisVac-C: Group 3
    Number of subjects analysed
    315 [7]
    306 [8]
    301 [9]
    Units: Titer
        geometric mean (confidence interval 95%)
    372.1 (339.4 to 408.1)
    401.8 (361.6 to 446.5)
    624.1 (568.2 to 685.5)
    Notes
    [7] - Number of subjects evaluable for this endpoint.
    [8] - Number of subjects evaluable for this endpoint.
    [9] - Number of subjects evaluable for this endpoint.
    No statistical analyses for this end point

    Secondary: Geometric Mean titer for Serum bactericidal Activity (rSBA) Prior to the Administration of the Booster Dose

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    End point title
    		 Geometric Mean titer for Serum bactericidal Activity (rSBA) Prior to the Administration of the Booster Dose
    End point description
    rSBA titers prior to the administration of booster dose of NeisVac-C was reported. The immunogenicity analysis data set contained all randomized and vaccinated subjects (at least one vaccination with NeisVac-C) with available data for the immunogenicity analysis, i.e. with both baseline and at least one post-baseline immunogenicity measurement available.
    End point type
    Secondary
    End point timeframe
    Before Booster dose
    End point values
    		 NeisVac-C: Group 1 NeisVac-C: Group 2 NeisVac-C: Group 3
    Number of subjects analysed
    297 [10]
    293 [11]
    285 [12]
    Units: Titer
        geometric mean (confidence interval 95%)
    38.5 (32.3 to 45.9)
    84.8 (71.9 to 100.1)
    29.5 (24.4 to 35.7)
    Notes
    [10] - Number of subjects evaluable for this endpoint.
    [11] - Number of subjects evaluable for this endpoint.
    [12] - Number of subjects evaluable for this endpoint.
    No statistical analyses for this end point

    Secondary: Geometric Mean Titer for Serum Bactericidal Activity (rSBA) 1 Month After the Administration of the Booster Dose.

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    End point title
    		 Geometric Mean Titer for Serum Bactericidal Activity (rSBA) 1 Month After the Administration of the Booster Dose.
    End point description
    rSBA titers after the administration of booster dose of NeisVac-C was reported. The immunogenicity analysis data set contained all randomized and vaccinated subjects (at least one vaccination with NeisVac-C) with available data for the immunogenicity analysis, i.e. with both baseline and at least one post-baseline immunogenicity measurement available.
    End point type
    Secondary
    End point timeframe
    1 month after booster dose
    End point values
    		 NeisVac-C: Group 1 NeisVac-C: Group 2 NeisVac-C: Group 3
    Number of subjects analysed
    302 [13]
    298 [14]
    288 [15]
    Units: Titer
        geometric mean (confidence interval 95%)
    2472.1 (2226.3 to 2745)
    1874.8 (1684.4 to 2086.6)
    1538 (1381.1 to 1712.6)
    Notes
    [13] - Number of subjects evaluable for this endpoint.
    [14] - Number of subjects evaluable for this endpoint.
    [15] - Number of subjects evaluable for this endpoint.
    No statistical analyses for this end point

    Secondary: Number of Subjects With Prespecified Injection Site Reactions by Severity

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    End point title
    		 Number of Subjects With Prespecified Injection Site Reactions by Severity
    End point description
    Injection site reactions includes injection site pain, tenderness, redness, swelling, and induration. The severity of injection site reactions was rated for Redness, induration or swelling (diameter) as Mild (1.0–2.5 cm), Moderate (2.5.–5.0 cm) Severe (> 5.0 cm) and for Injection site pain or tenderness as Mild (No impairment of arm movement), Moderate (Impairment of arm movement) and Severe (Severe impairment, arm not moving). The safety analysis set contained all subjects vaccinated at least once with NeisVac-C.
    End point type
    Secondary
    End point timeframe
    Within 3 days after primary, booster vaccination
    End point values
    		 NeisVac-C: Group 1 NeisVac-C: Group 2 NeisVac-C: Group 3
    Number of subjects analysed
    318
    312
    315
    Units: Subjects
    number (not applicable)
        After primary vaccination (Mild)
    97
    92
    128
        After primary vaccination (Moderate)
    35
    39
    50
        After primary vaccination (Severe)
    3
    7
    5
        After primary vaccination (Unknown)
    25
    20
    24
        After booster vaccination (Mild)
    92
    74
    81
        After booster vaccination (Moderate)
    44
    58
    47
        After booster vaccination (Severe)
    2
    13
    12
        After booster vaccination (Unknown)
    14
    14
    20
    No statistical analyses for this end point

    Secondary: Number of Subjects With Prespecified Systemic Reactions by Severity

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    End point title
    		 Number of Subjects With Prespecified Systemic Reactions by Severity
    End point description
    Systemic reactions are treatment-related systemic adverse events. Systemic reactions were reported in subject diary and includes vomiting, sweating, inconsolable or persisting crying, irritability, sleepiness, and food rejection. The safety analysis set contained all subjects vaccinated at least once with NeisVac-C.
    End point type
    Secondary
    End point timeframe
    Within 3 days after primary, booster vaccination
    End point values
    		 NeisVac-C: Group 1 NeisVac-C: Group 2 NeisVac-C: Group 3
    Number of subjects analysed
    318
    312
    315
    Units: Subjects
    number (not applicable)
        After primary vaccination (Mild)
    173
    157
    193
        After primary vaccination (Moderate)
    28
    16
    52
        After primary vaccination (Severe)
    0
    0
    2
        After primary vaccination (Unknown)
    0
    0
    0
        After booster vaccination (Mild)
    129
    135
    120
        After booster vaccination (Moderate)
    23
    30
    25
        After booster vaccination (Severe)
    1
    0
    0
        After booster vaccination (Unknown)
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Adverse Events

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    End point title
    		 Number of Subjects With Adverse Events
    End point description
    An Adverse Event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A Serious AE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. All the adverse events excluding serious adverse events were also reported. The safety analysis set contained all subjects vaccinated at least once with NeisVac-C.
    End point type
    Secondary
    End point timeframe
    Screening to 1 month after booster vaccination
    End point values
    		 NeisVac-C: Group 1 NeisVac-C: Group 2 NeisVac-C: Group 3
    Number of subjects analysed
    318
    312
    315
    Units: Number of subjects
    number (not applicable)
        Serious AEs
    50
    38
    34
        Any Non-Serious Systemic AEs
    312
    304
    305
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Screening to 1 month after booster vaccination
    Adverse event reporting additional description
    SAEs and AEs were grouped by system organ class and summarized. AEs included AEs collected in subject diary (local, systemic reactions) and AEs collected on case report form at each visit. MedDRA version was not captured, here 0.0 is included as dictionary version.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    0.0
    Reporting groups
    Reporting group title
    NeisVac-C: Group 1
    Reporting group description
    		 Subjects recieved single dose of NeisVac-C at 4 months of age along with Infanrix hexa and Prevenar 13 at 2, 4 and 6 months of age, and booster vaccination of all the vaccines between the age of 12 and 13 months.

    Reporting group title
    NeisVac-C: Group 2
    Reporting group description
    		 Subjects recieved single dose of NeisVac-C at 6 months of age along with Infanrix hexa and Prevenar 13 at 2, 4 and 6 months of age, and booster vaccination of all the vaccines between the age of 12 and 13 months.

    Reporting group title
    NeisVac-C: Group 3
    Reporting group description
    		 Subjects received two doses of NeisVac-C one each at 2 and 4 months of age along with Infanrix hexa and Prevenar 13 at 2, 4 and 6 months of age, with booster vaccinations of all the vaccines between 12 and 13 months of age.

    Serious adverse events
    		 NeisVac-C: Group 1 NeisVac-C: Group 2 NeisVac-C: Group 3
    Total subjects affected by serious adverse events
         subjects affected / exposed
    50 / 318 (15.72%)
    38 / 312 (12.18%)
    34 / 315 (10.79%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Nephroblastoma
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Phlebitis
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    0 / 315 (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
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 318 (0.63%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Balanitis
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (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
    Congenital, familial and genetic disorders
    Gene mutation
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neurological symptom
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    0 / 315 (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
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    0 / 315 (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
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (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
    Enterocolitis
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (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
    Gastritis
         subjects affected / exposed
    2 / 318 (0.63%)
    0 / 312 (0.00%)
    0 / 315 (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
    Gingivitis
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (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
    Intussusception
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    0 / 315 (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
    Stomatitis
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatitis
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    0 / 315 (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
    Erythema multiforme
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    0 / 315 (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
    Urticaria
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (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
    Anal abscess
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (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
    Bacterial infection
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    0 / 315 (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
    Bronchiolitis
         subjects affected / exposed
    4 / 318 (1.26%)
    3 / 312 (0.96%)
    1 / 315 (0.32%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    8 / 318 (2.52%)
    3 / 312 (0.96%)
    3 / 315 (0.95%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    1 / 318 (0.31%)
    1 / 312 (0.32%)
    4 / 315 (1.27%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Conjunctivitis infective
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (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
    Cytomegalovirus infection
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (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
    Dermatitis infected
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    0 / 315 (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 / 318 (0.31%)
    0 / 312 (0.00%)
    2 / 315 (0.63%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    6 / 318 (1.89%)
    8 / 312 (2.56%)
    5 / 315 (1.59%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 9
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    5 / 318 (1.57%)
    2 / 312 (0.64%)
    1 / 315 (0.32%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    1 / 318 (0.31%)
    2 / 312 (0.64%)
    0 / 315 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (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
    Laryngitis
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (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
    Meningococcal sepsis
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    8 / 318 (2.52%)
    8 / 312 (2.56%)
    3 / 315 (0.95%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 8
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia respiratory syncytial viral
         subjects affected / exposed
    2 / 318 (0.63%)
    0 / 312 (0.00%)
    0 / 315 (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
    Pyelonephritis
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    0 / 315 (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
    Pyelonephritis acute
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    2 / 318 (0.63%)
    0 / 312 (0.00%)
    0 / 315 (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
    Respiratory tract infection
         subjects affected / exposed
    1 / 318 (0.31%)
    3 / 312 (0.96%)
    2 / 315 (0.63%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rotavirus infection
         subjects affected / exposed
    2 / 318 (0.63%)
    0 / 312 (0.00%)
    0 / 315 (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
    Urinary tract infection
         subjects affected / exposed
    4 / 318 (1.26%)
    4 / 312 (1.28%)
    2 / 315 (0.63%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Varicella
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    0 / 315 (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
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    1 / 315 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 NeisVac-C: Group 1 NeisVac-C: Group 2 NeisVac-C: Group 3
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    312 / 318 (98.11%)
    304 / 312 (97.44%)
    305 / 315 (96.83%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Haemangioma
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    0
    0
    1
    Haemangioma of skin
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
         occurrences all number
    1
    0
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    0
    1
    0
    Discomfort
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    0
    0
    2
    Fatigue
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    0
    1
    0
    Injection site haematoma (Systemic)
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    0
    1
    0
    Injection site induration (Systemic)
         subjects affected / exposed
    1 / 318 (0.31%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    1
    1
    0
    Injection site pain (Systemic)
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    0
    2
    0
    Injection site swelling (Systemic)
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    0
    0
    1
    Irritability
         subjects affected / exposed
    165 / 318 (51.89%)
    187 / 312 (59.94%)
    169 / 315 (53.65%)
         occurrences all number
    320
    373
    328
    Nodule
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    0
    0
    1
    Pyrexia
         subjects affected / exposed
    207 / 318 (65.09%)
    206 / 312 (66.03%)
    179 / 315 (56.83%)
         occurrences all number
    385
    413
    350
    Tenderness
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    0
    2
    0
    Thirst
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
         occurrences all number
    1
    0
    0
    Vaccination site reaction
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
         occurrences all number
    1
    0
    0
    Vessel puncture site haematoma
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
         occurrences all number
    1
    0
    0
    Xerosis
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    0
    1
    0
    Injection site erythema
         subjects affected / exposed
    179 / 318 (56.29%)
    196 / 312 (62.82%)
    195 / 315 (61.90%)
         occurrences all number
    501
    610
    522
    Injection site haematoma
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    0
    0
    1
    Injection site induration
         subjects affected / exposed
    181 / 318 (56.92%)
    204 / 312 (65.38%)
    196 / 315 (62.22%)
         occurrences all number
    567
    692
    649
    Injection site inflammation
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    0
    0
    1
    Injection site oedema
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    0
    2
    0
    Injection site pain
         subjects affected / exposed
    144 / 318 (45.28%)
    156 / 312 (50.00%)
    153 / 315 (48.57%)
         occurrences all number
    681
    736
    712
    Injection site papule
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    0
    1
    0
    Injection site reaction
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    0
    1
    0
    Injection site swelling
         subjects affected / exposed
    130 / 318 (40.88%)
    146 / 312 (46.79%)
    136 / 315 (43.17%)
         occurrences all number
    329
    421
    354
    Injection site vesicles
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    0
    2
    0
    Injection site warmth
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    0
    0
    1
    Puncture site reaction
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    0
    0
    1
    Injection site rash
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    0
    0
    1
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    3 / 315 (0.95%)
         occurrences all number
    0
    0
    3
    Food allergy
         subjects affected / exposed
    0 / 318 (0.00%)
    3 / 312 (0.96%)
    2 / 315 (0.63%)
         occurrences all number
    0
    3
    2
    Milk allergy
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    1
    0
    1
    Seasonal allergy
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    0
    1
    0
    Reproductive system and breast disorders
    Genital labial adhesions
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    0
    1
    0
    Posthitis
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    1 / 315 (0.32%)
         occurrences all number
    0
    1
    2
    Respiratory, thoracic and mediastinal disorders
    Allergic cough
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    1
    0
    1
    Allergic respiratory symptom
         subjects affected / exposed
    2 / 318 (0.63%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
         occurrences all number
    2
    0
    0
    Asthma
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    0
    0
    1
    Bronchial hyperreactivity
         subjects affected / exposed
    0 / 318 (0.00%)
    2 / 312 (0.64%)
    1 / 315 (0.32%)
         occurrences all number
    0
    2
    1
    Bronchitis chronic
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    0
    1
    0
    Bronchospasm
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    0
    0
    5
    Cough
         subjects affected / exposed
    5 / 318 (1.57%)
    20 / 312 (6.41%)
    14 / 315 (4.44%)
         occurrences all number
    6
    23
    17
    Dysphonia
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    0
    1
    0
    Dyspnoea
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    0
    0
    1
    Interstitial lung disease
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
         occurrences all number
    1
    0
    0
    Nasal congestion
         subjects affected / exposed
    0 / 318 (0.00%)
    2 / 312 (0.64%)
    1 / 315 (0.32%)
         occurrences all number
    0
    2
    1
    Oropharyngeal pain
         subjects affected / exposed
    0 / 318 (0.00%)
    2 / 312 (0.64%)
    1 / 315 (0.32%)
         occurrences all number
    0
    2
    1
    Pulmonary artery stenosis
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
         occurrences all number
    1
    0
    0
    Rhinitis allergic
         subjects affected / exposed
    2 / 318 (0.63%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
         occurrences all number
    2
    0
    0
    Rhinitis seasonal
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
         occurrences all number
    1
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    0
    0
    2
    Wheezing
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
         occurrences all number
    1
    0
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
         occurrences all number
    1
    0
    0
    Apathy
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    0
    1
    0
    Decreased activity
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
         occurrences all number
    1
    0
    0
    Food aversion
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    0
    0
    1
    Psychomotor retardation
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    0
    0
    1
    Restlessness
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    0
    1
    0
    Sleep disorder
         subjects affected / exposed
    101 / 318 (31.76%)
    119 / 312 (38.14%)
    110 / 315 (34.92%)
         occurrences all number
    152
    180
    171
    Investigations
    Body temperature increased
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    1 / 315 (0.32%)
         occurrences all number
    0
    1
    1
    Cardiac murmur
         subjects affected / exposed
    3 / 318 (0.94%)
    2 / 312 (0.64%)
    2 / 315 (0.63%)
         occurrences all number
    3
    2
    2
    Cardiac murmur functional
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
         occurrences all number
    1
    0
    0
    Weight decreased
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    0
    0
    1
    Injury, poisoning and procedural complications
    Animal scratch
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    0
    1
    0
    Arthropod bite
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    0
    0
    1
    Burns second degree
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    0
    0
    1
    Clavicle fracture
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    0
    1
    0
    Eye injury
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    0
    1
    0
    Head injury
         subjects affected / exposed
    1 / 318 (0.31%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    1
    1
    0
    Joint dislocation
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    0
    0
    1
    Limb injury
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    2 / 315 (0.63%)
         occurrences all number
    0
    0
    2
    Multiple injuries
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    0
    0
    1
    Nail injury
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    0
    0
    1
    Procedural pain
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    0
    1
    0
    Road traffic accident
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    0
    0
    1
    Thermal burn
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    1
    0
    1
    Congenital, familial and genetic disorders
    Atrioventricular septal defect
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    0
    1
    0
    Craniotabes
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    0
    1
    0
    Dacryostenosis congenital
         subjects affected / exposed
    1 / 318 (0.31%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    1
    1
    0
    Hip dysplasia
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    1 / 315 (0.32%)
         occurrences all number
    0
    1
    1
    Hydrocele
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    2 / 315 (0.63%)
         occurrences all number
    0
    0
    2
    Phimosis
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    0
    1
    0
    Plagiocephaly
         subjects affected / exposed
    1 / 318 (0.31%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    1
    1
    0
    Nervous system disorders
    Coordination abnormal
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    0
    1
    0
    Crying
         subjects affected / exposed
    139 / 318 (43.71%)
    156 / 312 (50.00%)
    139 / 315 (44.13%)
         occurrences all number
    230
    239
    234
    Hydrocephalus
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    0
    0
    1
    Hypertonia
         subjects affected / exposed
    4 / 318 (1.26%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    4
    1
    0
    Hypotonia
         subjects affected / exposed
    2 / 318 (0.63%)
    1 / 312 (0.32%)
    1 / 315 (0.32%)
         occurrences all number
    2
    1
    1
    Somnolence
         subjects affected / exposed
    116 / 318 (36.48%)
    144 / 312 (46.15%)
    124 / 315 (39.37%)
         occurrences all number
    179
    233
    187
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    4 / 318 (1.26%)
    9 / 312 (2.88%)
    11 / 315 (3.49%)
         occurrences all number
    4
    9
    15
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    0
    0
    1
    Lymphadenitis
         subjects affected / exposed
    2 / 318 (0.63%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    2
    0
    1
    Lymphadenopathy
         subjects affected / exposed
    10 / 318 (3.14%)
    4 / 312 (1.28%)
    6 / 315 (1.90%)
         occurrences all number
    10
    4
    6
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    0
    0
    2
    Tympanic membrane hyperaemia
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
         occurrences all number
    1
    0
    0
    Eye disorders
    Conjunctival irritation
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    0
    1
    0
    Conjunctivitis
         subjects affected / exposed
    28 / 318 (8.81%)
    15 / 312 (4.81%)
    16 / 315 (5.08%)
         occurrences all number
    31
    17
    18
    Dacryostenosis acquired
         subjects affected / exposed
    1 / 318 (0.31%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    1
    1
    0
    Erythema of eyelid
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    0
    1
    0
    Eye discharge
         subjects affected / exposed
    0 / 318 (0.00%)
    3 / 312 (0.96%)
    0 / 315 (0.00%)
         occurrences all number
    0
    4
    0
    Eye inflammation
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    0
    1
    0
    Lacrimation increased
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    0
    0
    1
    Strabismus
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    2 / 315 (0.63%)
         occurrences all number
    0
    0
    2
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    0
    1
    0
    Abdominal pain
         subjects affected / exposed
    11 / 318 (3.46%)
    12 / 312 (3.85%)
    7 / 315 (2.22%)
         occurrences all number
    13
    13
    8
    Abdominal pain upper
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
         occurrences all number
    1
    0
    0
    Abnormal faeces
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
         occurrences all number
    1
    0
    0
    Aphthous stomatitis
         subjects affected / exposed
    6 / 318 (1.89%)
    3 / 312 (0.96%)
    1 / 315 (0.32%)
         occurrences all number
    6
    3
    1
    Constipation
         subjects affected / exposed
    6 / 318 (1.89%)
    6 / 312 (1.92%)
    7 / 315 (2.22%)
         occurrences all number
    6
    6
    7
    Diarrhoea
         subjects affected / exposed
    27 / 318 (8.49%)
    42 / 312 (13.46%)
    29 / 315 (9.21%)
         occurrences all number
    34
    50
    34
    Dyspepsia
         subjects affected / exposed
    0 / 318 (0.00%)
    3 / 312 (0.96%)
    2 / 315 (0.63%)
         occurrences all number
    0
    3
    2
    Enterocolitis
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    0
    1
    0
    Faeces discoloured
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
         occurrences all number
    1
    0
    0
    Flatulence
         subjects affected / exposed
    1 / 318 (0.31%)
    1 / 312 (0.32%)
    3 / 315 (0.95%)
         occurrences all number
    1
    1
    4
    Gastritis
         subjects affected / exposed
    0 / 318 (0.00%)
    2 / 312 (0.64%)
    0 / 315 (0.00%)
         occurrences all number
    0
    2
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    2 / 318 (0.63%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    2
    0
    1
    Gingival pain
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    1 / 315 (0.32%)
         occurrences all number
    0
    1
    1
    Gingivitis
         subjects affected / exposed
    1 / 318 (0.31%)
    1 / 312 (0.32%)
    1 / 315 (0.32%)
         occurrences all number
    1
    1
    1
    Infantile colic
         subjects affected / exposed
    1 / 318 (0.31%)
    1 / 312 (0.32%)
    2 / 315 (0.63%)
         occurrences all number
    1
    1
    2
    Inguinal hernia
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    1 / 315 (0.32%)
         occurrences all number
    0
    1
    1
    Mouth cyst
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    0
    1
    0
    Mucous stools
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
         occurrences all number
    1
    0
    0
    Oral pain
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    0
    0
    1
    Regurgitation
         subjects affected / exposed
    3 / 318 (0.94%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
         occurrences all number
    3
    0
    0
    Stomatitis
         subjects affected / exposed
    3 / 318 (0.94%)
    2 / 312 (0.64%)
    3 / 315 (0.95%)
         occurrences all number
    4
    2
    4
    Teething
         subjects affected / exposed
    22 / 318 (6.92%)
    25 / 312 (8.01%)
    19 / 315 (6.03%)
         occurrences all number
    35
    47
    31
    Vomiting
         subjects affected / exposed
    29 / 318 (9.12%)
    25 / 312 (8.01%)
    15 / 315 (4.76%)
         occurrences all number
    34
    31
    15
    Skin and subcutaneous tissue disorders
    Cafe au lait spots
         subjects affected / exposed
    1 / 318 (0.31%)
    1 / 312 (0.32%)
    1 / 315 (0.32%)
         occurrences all number
    1
    1
    1
    Dermal cyst
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    0
    0
    1
    Dermatitis
         subjects affected / exposed
    3 / 318 (0.94%)
    2 / 312 (0.64%)
    6 / 315 (1.90%)
         occurrences all number
    3
    2
    6
    Dermatitis allergic
         subjects affected / exposed
    15 / 318 (4.72%)
    9 / 312 (2.88%)
    13 / 315 (4.13%)
         occurrences all number
    17
    11
    16
    Dermatitis atopic
         subjects affected / exposed
    31 / 318 (9.75%)
    22 / 312 (7.05%)
    21 / 315 (6.67%)
         occurrences all number
    43
    23
    21
    Dermatitis diaper
         subjects affected / exposed
    6 / 318 (1.89%)
    6 / 312 (1.92%)
    5 / 315 (1.59%)
         occurrences all number
    6
    8
    5
    Dry skin
         subjects affected / exposed
    1 / 318 (0.31%)
    1 / 312 (0.32%)
    1 / 315 (0.32%)
         occurrences all number
    1
    1
    1
    Eczema
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
         occurrences all number
    1
    0
    0
    Erythema
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    0
    1
    0
    Heat rash
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    0
    1
    0
    Hyperhidrosis
         subjects affected / exposed
    28 / 318 (8.81%)
    41 / 312 (13.14%)
    40 / 315 (12.70%)
         occurrences all number
    36
    52
    58
    Papule
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    0
    0
    1
    Rash
         subjects affected / exposed
    8 / 318 (2.52%)
    7 / 312 (2.24%)
    9 / 315 (2.86%)
         occurrences all number
    8
    9
    9
    Rash macular
         subjects affected / exposed
    1 / 318 (0.31%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    1
    1
    0
    Rash papular
         subjects affected / exposed
    2 / 318 (0.63%)
    2 / 312 (0.64%)
    0 / 315 (0.00%)
         occurrences all number
    2
    2
    0
    Scab
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
         occurrences all number
    1
    0
    0
    Scar
         subjects affected / exposed
    2 / 318 (0.63%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
         occurrences all number
    2
    0
    0
    Seborrhoea
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    0
    0
    1
    Seborrhoeic dermatitis
         subjects affected / exposed
    3 / 318 (0.94%)
    2 / 312 (0.64%)
    5 / 315 (1.59%)
         occurrences all number
    3
    2
    5
    Skin depigmentation
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
         occurrences all number
    1
    0
    0
    Skin lesion
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    0
    0
    1
    Urticaria
         subjects affected / exposed
    1 / 318 (0.31%)
    1 / 312 (0.32%)
    2 / 315 (0.63%)
         occurrences all number
    1
    4
    2
    Renal and urinary disorders
    Pollakiuria
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    0
    1
    0
    Urine odour abnormal
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    0
    0
    1
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Delayed fontanelle closure
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    0
    0
    1
    Facial asymmetry
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    0
    1
    0
    Rickets
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
         occurrences all number
    1
    0
    0
    Torticollis
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    Acute tonsillitis
         subjects affected / exposed
    4 / 318 (1.26%)
    1 / 312 (0.32%)
    6 / 315 (1.90%)
         occurrences all number
    5
    2
    7
    Bacteriuria
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
         occurrences all number
    1
    0
    0
    Bronchiolitis
         subjects affected / exposed
    9 / 318 (2.83%)
    8 / 312 (2.56%)
    13 / 315 (4.13%)
         occurrences all number
    12
    12
    16
    Bronchitis
         subjects affected / exposed
    69 / 318 (21.70%)
    60 / 312 (19.23%)
    48 / 315 (15.24%)
         occurrences all number
    95
    79
    66
    Candida nappy rash
         subjects affected / exposed
    1 / 318 (0.31%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    3
    1
    0
    Candidiasis
         subjects affected / exposed
    2 / 318 (0.63%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
         occurrences all number
    2
    0
    0
    Conjunctivitis infective
         subjects affected / exposed
    1 / 318 (0.31%)
    4 / 312 (1.28%)
    1 / 315 (0.32%)
         occurrences all number
    1
    5
    1
    Cystitis
         subjects affected / exposed
    0 / 318 (0.00%)
    2 / 312 (0.64%)
    0 / 315 (0.00%)
         occurrences all number
    0
    2
    0
    Dacryocanaliculitis
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    0
    0
    1
    Dermatophytosis
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
         occurrences all number
    1
    0
    0
    Ear infection
         subjects affected / exposed
    10 / 318 (3.14%)
    4 / 312 (1.28%)
    6 / 315 (1.90%)
         occurrences all number
    14
    4
    8
    Enterobiasis
         subjects affected / exposed
    2 / 318 (0.63%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    2
    1
    0
    Enterocolitis infectious
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    1 / 315 (0.32%)
         occurrences all number
    0
    1
    1
    Erythema infectiosum
         subjects affected / exposed
    0 / 318 (0.00%)
    2 / 312 (0.64%)
    0 / 315 (0.00%)
         occurrences all number
    0
    2
    0
    Escherichia infection
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
         occurrences all number
    1
    0
    0
    Exanthema subitum
         subjects affected / exposed
    23 / 318 (7.23%)
    40 / 312 (12.82%)
    29 / 315 (9.21%)
         occurrences all number
    32
    41
    29
    Fungal infection
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    0
    0
    1
    Fungal skin infection
         subjects affected / exposed
    1 / 318 (0.31%)
    2 / 312 (0.64%)
    1 / 315 (0.32%)
         occurrences all number
    1
    2
    1
    Gastroenteritis
         subjects affected / exposed
    14 / 318 (4.40%)
    18 / 312 (5.77%)
    12 / 315 (3.81%)
         occurrences all number
    15
    19
    14
    Gastroenteritis rotavirus
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal infection
         subjects affected / exposed
    1 / 318 (0.31%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    1
    1
    0
    Gastrointestinal viral infection
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    0
    1
    0
    Herpangina
         subjects affected / exposed
    0 / 318 (0.00%)
    2 / 312 (0.64%)
    1 / 315 (0.32%)
         occurrences all number
    0
    2
    1
    Herpes dermatitis
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
         occurrences all number
    1
    0
    0
    Impetigo
         subjects affected / exposed
    4 / 318 (1.26%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    4
    0
    1
    Infection
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
         occurrences all number
    1
    0
    0
    Laryngitis
         subjects affected / exposed
    6 / 318 (1.89%)
    11 / 312 (3.53%)
    6 / 315 (1.90%)
         occurrences all number
    8
    11
    6
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    0
    1
    0
    Mononucleosis syndrome
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    0
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    70 / 318 (22.01%)
    55 / 312 (17.63%)
    62 / 315 (19.68%)
         occurrences all number
    116
    80
    105
    Oral candidiasis
         subjects affected / exposed
    4 / 318 (1.26%)
    6 / 312 (1.92%)
    4 / 315 (1.27%)
         occurrences all number
    6
    6
    5
    Oral herpes
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    1 / 315 (0.32%)
         occurrences all number
    0
    1
    1
    Otitis externa
         subjects affected / exposed
    0 / 318 (0.00%)
    3 / 312 (0.96%)
    0 / 315 (0.00%)
         occurrences all number
    0
    3
    0
    Otitis media
         subjects affected / exposed
    12 / 318 (3.77%)
    13 / 312 (4.17%)
    12 / 315 (3.81%)
         occurrences all number
    15
    15
    16
    Otitis media acute
         subjects affected / exposed
    4 / 318 (1.26%)
    1 / 312 (0.32%)
    3 / 315 (0.95%)
         occurrences all number
    4
    1
    3
    Pertussis
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
         occurrences all number
    1
    0
    0
    Pharyngitis
         subjects affected / exposed
    44 / 318 (13.84%)
    48 / 312 (15.38%)
    37 / 315 (11.75%)
         occurrences all number
    49
    67
    46
    Pharyngotonsillitis
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    0
    0
    1
    Pneumonia
         subjects affected / exposed
    7 / 318 (2.20%)
    2 / 312 (0.64%)
    3 / 315 (0.95%)
         occurrences all number
    7
    2
    3
    Pyelonephritis
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
         occurrences all number
    1
    0
    0
    Rash pustular
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    0
    0
    1
    Respiratory tract infection
         subjects affected / exposed
    26 / 318 (8.18%)
    21 / 312 (6.73%)
    30 / 315 (9.52%)
         occurrences all number
    33
    26
    32
    Respiratory tract infection viral
         subjects affected / exposed
    2 / 318 (0.63%)
    5 / 312 (1.60%)
    1 / 315 (0.32%)
         occurrences all number
    2
    6
    2
    Roseola
         subjects affected / exposed
    5 / 318 (1.57%)
    2 / 312 (0.64%)
    1 / 315 (0.32%)
         occurrences all number
    5
    2
    1
    Scarlet fever
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    0
    0
    1
    Sialoadenitis
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
         occurrences all number
    1
    0
    0
    Skin bacterial infection
         subjects affected / exposed
    1 / 318 (0.31%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    1
    1
    0
    Skin candida
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    1 / 315 (0.32%)
         occurrences all number
    0
    1
    1
    Skin infection
         subjects affected / exposed
    2 / 318 (0.63%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    3
    0
    1
    Staphylococcal skin infection
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
         occurrences all number
    1
    0
    0
    Tonsillitis
         subjects affected / exposed
    6 / 318 (1.89%)
    12 / 312 (3.85%)
    6 / 315 (1.90%)
         occurrences all number
    8
    12
    6
    Tonsillitis streptococcal
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    0
    0
    1
    Tracheitis
         subjects affected / exposed
    0 / 318 (0.00%)
    4 / 312 (1.28%)
    2 / 315 (0.63%)
         occurrences all number
    0
    4
    2
    Upper respiratory tract infection
         subjects affected / exposed
    87 / 318 (27.36%)
    78 / 312 (25.00%)
    98 / 315 (31.11%)
         occurrences all number
    145
    126
    159
    Urinary tract infection
         subjects affected / exposed
    11 / 318 (3.46%)
    11 / 312 (3.53%)
    8 / 315 (2.54%)
         occurrences all number
    15
    13
    9
    Varicella
         subjects affected / exposed
    3 / 318 (0.94%)
    6 / 312 (1.92%)
    8 / 315 (2.54%)
         occurrences all number
    3
    6
    8
    Viral infection
         subjects affected / exposed
    0 / 318 (0.00%)
    6 / 312 (1.92%)
    5 / 315 (1.59%)
         occurrences all number
    0
    6
    5
    Viral rash
         subjects affected / exposed
    3 / 318 (0.94%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
         occurrences all number
    3
    0
    0
    Viral skin infection
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    0
    0
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    2 / 318 (0.63%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    3
    1
    0
    Vulvitis
         subjects affected / exposed
    3 / 318 (0.94%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    4
    1
    0
    Vulvovaginal candidiasis
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    1
    0
    3
    Vulvovaginitis
         subjects affected / exposed
    1 / 318 (0.31%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    1
    1
    0
    Injection site pustule
         subjects affected / exposed
    0 / 318 (0.00%)
    1 / 312 (0.32%)
    0 / 315 (0.00%)
         occurrences all number
    0
    1
    0
    Metabolism and nutrition disorders
    Cow's milk intolerance
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    1
    0
    1
    Decreased appetite
         subjects affected / exposed
    107 / 318 (33.65%)
    118 / 312 (37.82%)
    113 / 315 (35.87%)
         occurrences all number
    152
    173
    177
    Dehydration
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
         occurrences all number
    1
    0
    0
    Feeding disorder neonatal
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    0
    0
    1
    Increased appetite
         subjects affected / exposed
    0 / 318 (0.00%)
    2 / 312 (0.64%)
    1 / 315 (0.32%)
         occurrences all number
    0
    2
    1
    Iron deficiency
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    0
    0
    1
    Lactose intolerance
         subjects affected / exposed
    1 / 318 (0.31%)
    0 / 312 (0.00%)
    0 / 315 (0.00%)
         occurrences all number
    1
    0
    0
    Underweight
         subjects affected / exposed
    0 / 318 (0.00%)
    0 / 312 (0.00%)
    1 / 315 (0.32%)
         occurrences all number
    0
    0
    1
    Weight gain poor
         subjects affected / exposed
    1 / 318 (0.31%)
    1 / 312 (0.32%)
    1 / 315 (0.32%)
         occurrences all number
    1
    1
    1

    More information

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

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

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

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