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    Clinical Trial Results:
    A Phase III, observer-blind, randomized, multicenter study to evaluate immunogenicity, reactogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ Rotarix Porcine circovirus (PCV)-free liquid as compared to GSK’s Rotarix liquid, given in 2‑doses in healthy Chinese infants starting at age 6-16 weeks

    Summary
    EudraCT number
    		 2020-000972-38
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    23 Oct 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 May 2025
    First version publication date
    09 May 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    212692
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT06025695
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    Rue del’Institut, 89, Rixensart, Belgium, 1330
    Public contact
    GSK Response Center, GlaxoSmithKline, 044 8664357343, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 044 8664357343, GSKClinicalSupportHD@gsk.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
    19 Dec 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Oct 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this study is to evaluate the immunogenicity, reactogenicity and safety of GSK’s HRV PCV-free vaccine compared to HRV vaccine in healthy Chinese infants 6-16 weeks of age.
    Protection of trial subjects
    The participants were observed closely for at least 30 minutes after the administration of the study interventions. Appropriate medical treatment was readily available during the observation period in case of anaphylaxis and/or syncope.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 2023
    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
    China: 2000
    Worldwide total number of subjects
    2000
    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)
    2000
    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
    		 This study was conducted in China.

    Pre-assignment
    Screening details
    		 One participant was randomized to the HRV group but was vaccinated in the HRV PCV-free group. Data for this participant was analyzed in the HRV PCV-free group for all analyses.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Monitor, Subject, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Human Rotavirus (HRV) Group
    Arm description
    		 Participants received 2 doses of GSK’s liquid oral live attenuated HRV study intervention at Day 1 and Month 1.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    GSK’s liquid oral live attenuated human rotavirus (HRV) vaccine
    Investigational medicinal product code
    Other name
    Rotarix
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    2 doses per participant

    Arm title
    		 HRV Porcine Circovirus (PCV)-free Group
    Arm description
    		 Participants received 2 doses of the PCV-free liquid formulation of GSK’s oral live attenuated HRV study intervention at Day 1 and Month 1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Porcine circovirus (PCV)-free liquid formulation of GlaxoSmithKline Biologicals SA (GSK) oral live attenuated human rotavirus (HRV) vaccine
    Investigational medicinal product code
    Other name
    Rotarix PCV-free
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    2 doses per participant

    Number of subjects in period 1
    		Human Rotavirus (HRV) Group HRV Porcine Circovirus (PCV)-free Group
    Started
    998
    1002
    Completed
    956
    967
    Not completed
    42
    35
         Migrated / Moved from the Study Area
    13
    10
         Adverse event, non-fatal
    5
    6
         Not Specified
    23
    19
         Adverse Event Requiring Expedited Report
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Human Rotavirus (HRV) Group
    Reporting group description
    		 Participants received 2 doses of GSK’s liquid oral live attenuated HRV study intervention at Day 1 and Month 1.

    Reporting group title
    HRV Porcine Circovirus (PCV)-free Group
    Reporting group description
    		 Participants received 2 doses of the PCV-free liquid formulation of GSK’s oral live attenuated HRV study intervention at Day 1 and Month 1.

    Reporting group values
    		 Human Rotavirus (HRV) Group HRV Porcine Circovirus (PCV)-free Group Total
    Number of subjects
    		 998 1002 2000
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 998 1002 2000
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Sex: Female, Male
    Units: Participants
        MALE
    		 543 490 1033
        FEMALE
    		 455 512 967
    Race/Ethnicity, Customized
    Units: Subjects
        ASIAN - EAST ASIAN HERITAGE
    		 998 1002 2000

    End points

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    End points reporting groups
    Reporting group title
    Human Rotavirus (HRV) Group
    Reporting group description
    		 Participants received 2 doses of GSK’s liquid oral live attenuated HRV study intervention at Day 1 and Month 1.

    Reporting group title
    HRV Porcine Circovirus (PCV)-free Group
    Reporting group description
    		 Participants received 2 doses of the PCV-free liquid formulation of GSK’s oral live attenuated HRV study intervention at Day 1 and Month 1.

    Primary: Percentage of participants with anti-rotavirus (RV) immunoglobulin A (IgA) antibody (Ab) seroconversion rate

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    End point title
    		 Percentage of participants with anti-rotavirus (RV) immunoglobulin A (IgA) antibody (Ab) seroconversion rate
    End point description
    Seroconversion rate is defined as the percentage of participants who were initially seronegative (i.e., with anti-RV IgA Ab concentration below [<] 20 unit per milliliter [U/mL] prior the first dose of study intervention) and developed anti-RV IgA Ab concentration greater than or equal to (>=) 20 U/mL at Month 2 (1-month post-Dose 2). Analysis was performed on Per Protocol Set (PPS), which includes all participants who adhered to the study protocol, ensuring they received no unapproved treatments, remained blinded, had anti-RV concentration <20 U/mL before intervention, had available anti-RV results at Month 2, complied with blood sampling schedules, and had no concurrent infections. Only participants with data available at specified timepoints were included in the analysis.
    End point type
    Primary
    End point timeframe
    At Month 2 (1-month post-dose 2)
    End point values
    		 Human Rotavirus (HRV) Group HRV Porcine Circovirus (PCV)-free Group
    Number of subjects analysed
    865
    870
    Units: Percentage of participants
        number (confidence interval 95%)
    88.7 (86.4 to 90.7)
    84.9 (82.4 to 87.3)
    Statistical analysis title
    		 Between-group analysis
    Statistical analysis description
    To demonstrate the immunological non-inferiority of HRV PCV-free Group as compared to HRV Group in terms of seroconversion rates 1 month post Dose 2
    Comparison groups
    Human Rotavirus (HRV) Group v HRV Porcine Circovirus (PCV)-free Group
    Number of subjects included in analysis
    1735
    Analysis specification
    Pre-specified
    Analysis type
    		 [1]
    Method
    Parameter type
    		 Difference in seroconversion rate
    Point estimate
    -3.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.93
         upper limit
    		 -0.55
    Notes
    [1] - Non-inferiority (NI) was to be demonstrated if the lower limit (LL) of the two-sided asymptotic standardized 95% confidence interval (CI) for the difference in seroconversion rate between the HRV PCV -free group and HRV group is greater than or equal to -10%

    Primary: Serum anti-RV IgA Ab concentrations expressed as Geometric Mean Concentrations (GMCs)

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    End point title
    		 Serum anti-RV IgA Ab concentrations expressed as Geometric Mean Concentrations (GMCs)
    End point description
    Analysis was performed on PPS. Only participants with data available at the specified timepoints were included in this analysis.
    End point type
    Primary
    End point timeframe
    At Month 2 (1-month post-Dose 2)
    End point values
    		 Human Rotavirus (HRV) Group HRV Porcine Circovirus (PCV)-free Group
    Number of subjects analysed
    865
    870
    Units: U/mL
        geometric mean (confidence interval 95%)
    222.82 (198.03 to 250.71)
    157.31 (139.31 to 177.64)
    Statistical analysis title
    		 Between-group analysis
    Statistical analysis description
    To demonstrate the non-inferiority of the HRV PCV-free Group as compared to HRV Group in terms of serum anti-RV IgA Ab concentrations 1 month post Dose 2.
    Comparison groups
    Human Rotavirus (HRV) Group v HRV Porcine Circovirus (PCV)-free Group
    Number of subjects included in analysis
    1735
    Analysis specification
    Pre-specified
    Analysis type
    		 [2]
    Method
    Parameter type
    		 GMC Ratio
    Point estimate
    0.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 0.84
    Notes
    [2] - NI was to be demonstrated if the LL of the two-sided 95% CI for the ratio of anti-RV IgA Ab GMC between the HRV PCV-free group and HRV group is greater than or equal to 0.67.

    Secondary: Percentage of participants with serum anti-RV IgA Ab concentrations >= 90 U/mL

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    End point title
    		 Percentage of participants with serum anti-RV IgA Ab concentrations >= 90 U/mL
    End point description
    Analysis was performed on PPS. Only participants with data available at the specified timepoints were included in this analysis.
    End point type
    Secondary
    End point timeframe
    At Month 2 (1-month post-Dose 2)
    End point values
    		 Human Rotavirus (HRV) Group HRV Porcine Circovirus (PCV)-free Group
    Number of subjects analysed
    865
    870
    Units: Percentage of participants
        number (confidence interval 95%)
    69.2 (66.1 to 72.3)
    62.9 (59.6 to 66.1)
    Statistical analysis title
    		 Between-group analysis
    Statistical analysis description
    To demonstrate the immunological non-inferiority of HRV PCV-free Group as compared to HRV Group in terms of percentage of participants with anti-RV IgA antibody concentrations >=90 U/mL 1 month post Dose 2.
    Comparison groups
    Human Rotavirus (HRV) Group v HRV Porcine Circovirus (PCV)-free Group
    Number of subjects included in analysis
    1735
    Analysis specification
    Pre-specified
    Analysis type
    		 [3]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -6.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.81
         upper limit
    		 -1.92
    Notes
    [3] - NI was to be demonstrated if the LL of the two-sided asymptotic standardized 95% CI for the difference in the percentage between the HRV PCV-free group and HRV group is greater than or equal to -10%.

    Secondary: Number of participants reporting solicited systemic events

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    End point title
    		 Number of participants reporting solicited systemic events
    End point description
    Solicited systemic events include fever/pyrexia, diarrhoea, vomiting, irritability/fussiness, loss of appetite, cough/runny nose. Fever is defined as body temperature >= 37.5 degrees Celsius (°C) and the preferred location for measuring temperature is the axilla. Any = occurrence of the event regardless of intensity grade or relation to the study vaccination. Analysis was performed on the Exposed Set which includes all participants with at least 1 dose of the study intervention administered and with the solicited systemic events diary card data available after the corresponding vaccination for the specified timepoint.
    End point type
    Secondary
    End point timeframe
    Within 14 days (the day of vaccination and 13 subsequent days) after each vaccination (occurring at Day 1 and Month 1)
    End point values
    		 Human Rotavirus (HRV) Group HRV Porcine Circovirus (PCV)-free Group
    Number of subjects analysed
    973
    986
    Units: Participants
        Cough/Runny Nose, post vaccination at Day 1
    158
    200
        Cough/Runny Nose, post vaccination at Month 1
    131
    157
        Diarrhoea, post vaccination at Day 1
    66
    66
        Diarrhoea, post vaccination at Month 1
    38
    40
        Fever/Pyrexia, post vaccination at Day 1
    122
    100
        Fever/Pyrexia, post vaccination at Month 1
    104
    91
        Irritability, post vaccination at Day 1
    126
    150
        Irritability, post vaccination at Month 1
    61
    59
        Loss of appetite, post vaccination at Day 1
    73
    92
        Loss of appetite, post vaccination at Month 1
    32
    34
        Vomiting, post vaccination at Day 1
    71
    69
        Vomiting, post vaccination at Month 1
    30
    36
    No statistical analyses for this end point

    Secondary: Number of participants reporting unsolicited adverse events (AEs)

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    End point title
    		 Number of participants reporting unsolicited adverse events (AEs)
    End point description
    Unsolicited AEs include any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event. Any = occurrence the event regardless of intensity grade or relation to the study vaccination. Analysis was performed on the Exposed Set which includes all participants with at least 1 dose of the study intervention administered and for whom unsolicited AEs data were available after the corresponding vaccination for the specified timepoint.
    End point type
    Secondary
    End point timeframe
    Within 31 days (the day of vaccination and 30 subsequent days) after each vaccination (occurring at Day 1 and Month 1)
    End point values
    		 Human Rotavirus (HRV) Group HRV Porcine Circovirus (PCV)-free Group
    Number of subjects analysed
    998
    1002
    Units: Participants
        Post-vaccination at Day 1
    236
    234
        Post-vaccination at Month 1
    223
    229
    No statistical analyses for this end point

    Secondary: Number of participants reporting serious adverse events (SAEs)

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    End point title
    		 Number of participants reporting serious adverse events (SAEs)
    End point description
    An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or in other situations that are considered serious as per medical or scientific judgment. Any = occurrence of the SAE regardless of intensity grade or relation to the study vaccination. Analysis was performed on the Exposed Set which includes all participants with at least 1 dose of the study intervention administered and for whom SAE data were available after the corresponding vaccination for the specified timepoint.
    End point type
    Secondary
    End point timeframe
    From Day 1 to Month 7
    End point values
    		 Human Rotavirus (HRV) Group HRV Porcine Circovirus (PCV)-free Group
    Number of subjects analysed
    998
    1002
    Units: Participants
    251
    262
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited AEs: during the 14-day follow-up period (from Day 1 to Day 14) after any vaccination and unsolicited AEs: during the 31-day follow-up period after any vaccination (from Day 1 to Day 31). All cause mortality and SAEs: From Day 1 to Month 7.
    Adverse event reporting additional description
    SAEs, solicited AEs and unsolicited AEs were reported for the Exposed set.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    HRV Porcine Circovirus (PCV)-free Group
    Reporting group description
    		 Participants received 2 doses of the PCV-free liquid formulation of GSK’s oral live attenuated HRV study intervention at Day 1 and Month 1.

    Reporting group title
    Human Rotavirus (HRV) Group
    Reporting group description
    		 Participants received 2 doses of GSK’s liquid oral live attenuated HRV study intervention at Day 1 and Month 1.

    Serious adverse events
    		 HRV Porcine Circovirus (PCV)-free Group Human Rotavirus (HRV) Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    262 / 1002 (26.15%)
    251 / 998 (25.15%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lymphangioma
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Shock
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Food allergy
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    6 / 1002 (0.60%)
    3 / 998 (0.30%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Craniocerebral injury
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Skull fracture
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thermal burn
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Congenital megacolon
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniosynostosis
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular malformation
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    4 / 1002 (0.40%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure acute
         subjects affected / exposed
    1 / 1002 (0.10%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Febrile convulsion
         subjects affected / exposed
    2 / 1002 (0.20%)
    2 / 998 (0.20%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Loss of consciousness
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coordination abnormal
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Immune thrombocytopenia
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Enteritis
         subjects affected / exposed
    5 / 1002 (0.50%)
    6 / 998 (0.60%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infantile diarrhoea
         subjects affected / exposed
    4 / 1002 (0.40%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    2 / 1002 (0.20%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Functional gastrointestinal disorder
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorder
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incarcerated inguinal hernia
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intussusception
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mouth ulceration
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Liver injury
         subjects affected / exposed
    1 / 1002 (0.10%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    1 / 1002 (0.10%)
    2 / 998 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis allergic
         subjects affected / exposed
    2 / 1002 (0.20%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    2 / 1002 (0.20%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis atopic
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    11 / 1002 (1.10%)
    11 / 998 (1.10%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile infection
         subjects affected / exposed
    20 / 1002 (2.00%)
    21 / 998 (2.10%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 23
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    36 / 1002 (3.59%)
    39 / 998 (3.91%)
         occurrences causally related to treatment / all
    0 / 37
    0 / 41
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    138 / 1002 (13.77%)
    140 / 998 (14.03%)
         occurrences causally related to treatment / all
    0 / 160
    0 / 163
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    8 / 1002 (0.80%)
    3 / 998 (0.30%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    6 / 1002 (0.60%)
    6 / 998 (0.60%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    6 / 1002 (0.60%)
    6 / 998 (0.60%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    13 / 1002 (1.30%)
    5 / 998 (0.50%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    3 / 1002 (0.30%)
    3 / 998 (0.30%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterobacter pneumonia
         subjects affected / exposed
    3 / 1002 (0.30%)
    2 / 998 (0.20%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia escherichia
         subjects affected / exposed
    0 / 1002 (0.00%)
    4 / 998 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia staphylococcal
         subjects affected / exposed
    1 / 1002 (0.10%)
    3 / 998 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    6 / 1002 (0.60%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    5 / 1002 (0.50%)
    2 / 998 (0.20%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia haemophilus
         subjects affected / exposed
    4 / 1002 (0.40%)
    3 / 998 (0.30%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    4 / 1002 (0.40%)
    3 / 998 (0.30%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    2 / 1002 (0.20%)
    5 / 998 (0.50%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngopharyngitis
         subjects affected / exposed
    1 / 1002 (0.10%)
    6 / 998 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpangina
         subjects affected / exposed
    5 / 1002 (0.50%)
    3 / 998 (0.30%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngitis
         subjects affected / exposed
    3 / 1002 (0.30%)
    7 / 998 (0.70%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia klebsiella
         subjects affected / exposed
    2 / 1002 (0.20%)
    2 / 998 (0.20%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    2 / 1002 (0.20%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea infectious
         subjects affected / exposed
    2 / 1002 (0.20%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia mycoplasmal
         subjects affected / exposed
    1 / 1002 (0.10%)
    2 / 998 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheobronchitis mycoplasmal
         subjects affected / exposed
    3 / 1002 (0.30%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    3 / 1002 (0.30%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis mycoplasmal
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheitis
         subjects affected / exposed
    0 / 1002 (0.00%)
    2 / 998 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial infection
         subjects affected / exposed
    1 / 1002 (0.10%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    1 / 1002 (0.10%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Exanthema subitum
         subjects affected / exposed
    1 / 1002 (0.10%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis adenovirus
         subjects affected / exposed
    1 / 1002 (0.10%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia parainfluenzae viral
         subjects affected / exposed
    1 / 1002 (0.10%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    1 / 1002 (0.10%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis bacterial
         subjects affected / exposed
    1 / 1002 (0.10%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 1002 (0.10%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pertussis
         subjects affected / exposed
    2 / 1002 (0.20%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mycoplasma infection
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis bacterial
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coxsackie viral infection
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis bacterial
         subjects affected / exposed
    2 / 1002 (0.20%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia respiratory syncytial viral
         subjects affected / exposed
    0 / 1002 (0.00%)
    2 / 998 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia pneumococcal
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia pseudomonal
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal abscess
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial diarrhoea
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis mycoplasmal
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronavirus pneumonia
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal bacterial infection
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemophilus infection
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hand-foot-and-mouth disease
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impetigo
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media acute
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia moraxella
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia streptococcal
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicella
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin infection
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypokalaemia
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 HRV Porcine Circovirus (PCV)-free Group Human Rotavirus (HRV) Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    617 / 1002 (61.58%)
    596 / 998 (59.72%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Haemangioma of skin
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    178 / 1002 (17.76%)
    178 / 998 (17.84%)
         occurrences all number
    195
    201
    Peripheral swelling
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences all number
    0
    1
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences all number
    1
    0
    Transient hypogammaglobulinaemia of infancy
         subjects affected / exposed
    2 / 1002 (0.20%)
    2 / 998 (0.20%)
         occurrences all number
    2
    2
    Respiratory, thoracic and mediastinal disorders
    Nasal obstruction
         subjects affected / exposed
    25 / 1002 (2.50%)
    35 / 998 (3.51%)
         occurrences all number
    26
    39
    Rhinorrhoea
         subjects affected / exposed
    81 / 1002 (8.08%)
    61 / 998 (6.11%)
         occurrences all number
    86
    62
    Cough
         subjects affected / exposed
    87 / 1002 (8.68%)
    91 / 998 (9.12%)
         occurrences all number
    94
    96
    Nasal congestion
         subjects affected / exposed
    13 / 1002 (1.30%)
    9 / 998 (0.90%)
         occurrences all number
    14
    9
    Sneezing
         subjects affected / exposed
    6 / 1002 (0.60%)
    9 / 998 (0.90%)
         occurrences all number
    8
    9
    Productive cough
         subjects affected / exposed
    1 / 1002 (0.10%)
    3 / 998 (0.30%)
         occurrences all number
    1
    3
    Pharyngeal erythema
         subjects affected / exposed
    2 / 1002 (0.20%)
    2 / 998 (0.20%)
         occurrences all number
    2
    2
    Sputum retention
         subjects affected / exposed
    2 / 1002 (0.20%)
    1 / 998 (0.10%)
         occurrences all number
    2
    1
    Pharyngeal swelling
         subjects affected / exposed
    1 / 1002 (0.10%)
    1 / 998 (0.10%)
         occurrences all number
    1
    1
    Dysphonia
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences all number
    0
    1
    Increased upper airway secretion
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences all number
    0
    1
    Laryngeal obstruction
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences all number
    0
    1
    Rhinitis allergic
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences all number
    0
    1
    Hypoventilation neonatal
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences all number
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences all number
    1
    0
    Wheezing
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Irritability
         subjects affected / exposed
    155 / 1002 (15.47%)
    149 / 998 (14.93%)
         occurrences all number
    191
    179
    Sleep terror
         subjects affected / exposed
    2 / 1002 (0.20%)
    0 / 998 (0.00%)
         occurrences all number
    3
    0
    Investigations
    Myocardial necrosis marker increased
         subjects affected / exposed
    9 / 1002 (0.90%)
    10 / 998 (1.00%)
         occurrences all number
    9
    11
    Immunoglobulins decreased
         subjects affected / exposed
    2 / 1002 (0.20%)
    2 / 998 (0.20%)
         occurrences all number
    2
    2
    Liver function test abnormal
         subjects affected / exposed
    3 / 1002 (0.30%)
    1 / 998 (0.10%)
         occurrences all number
    3
    1
    Blood lactate dehydrogenase increased
         subjects affected / exposed
    1 / 1002 (0.10%)
    2 / 998 (0.20%)
         occurrences all number
    1
    2
    Bile acids increased
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences all number
    0
    1
    Occult blood positive
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences all number
    0
    1
    Transaminases increased
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences all number
    0
    1
    Congenital, familial and genetic disorders
    Atrial septal defect
         subjects affected / exposed
    1 / 1002 (0.10%)
    1 / 998 (0.10%)
         occurrences all number
    1
    1
    Congenital laryngeal stridor
         subjects affected / exposed
    1 / 1002 (0.10%)
    1 / 998 (0.10%)
         occurrences all number
    1
    1
    Ventricular septal defect
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences all number
    0
    1
    Congenital laryngeal malformation
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences all number
    2
    0
    Cardiac disorders
    Myocardial injury
         subjects affected / exposed
    7 / 1002 (0.70%)
    3 / 998 (0.30%)
         occurrences all number
    7
    3
    Sinus arrhythmia
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences all number
    0
    1
    Sinus tachycardia
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences all number
    0
    1
    Myocarditis
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Drooling
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences all number
    1
    0
    Somnolence
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Coagulopathy
         subjects affected / exposed
    1 / 1002 (0.10%)
    2 / 998 (0.20%)
         occurrences all number
    1
    2
    Anaemia
         subjects affected / exposed
    1 / 1002 (0.10%)
    5 / 998 (0.50%)
         occurrences all number
    1
    5
    Neutropenia
         subjects affected / exposed
    0 / 1002 (0.00%)
    2 / 998 (0.20%)
         occurrences all number
    0
    2
    Granulocytopenia
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences all number
    0
    1
    Hypofibrinogenaemia
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences all number
    0
    1
    Leukopenia
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences all number
    0
    1
    Secondary thrombocytosis
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences all number
    0
    1
    Agranulocytosis
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences all number
    1
    0
    Thrombocytopenia
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences all number
    1
    0
    Eye disorders
    Eye discharge
         subjects affected / exposed
    0 / 1002 (0.00%)
    3 / 998 (0.30%)
         occurrences all number
    0
    3
    Dacryostenosis acquired
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences all number
    0
    1
    Blepharitis
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences all number
    1
    0
    Keratitis
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    95 / 1002 (9.48%)
    85 / 998 (8.52%)
         occurrences all number
    106
    98
    Diarrhoea
         subjects affected / exposed
    118 / 1002 (11.78%)
    123 / 998 (12.32%)
         occurrences all number
    131
    133
    Constipation
         subjects affected / exposed
    18 / 1002 (1.80%)
    13 / 998 (1.30%)
         occurrences all number
    18
    13
    Abdominal distension
         subjects affected / exposed
    3 / 1002 (0.30%)
    2 / 998 (0.20%)
         occurrences all number
    3
    2
    Infantile diarrhoea
         subjects affected / exposed
    3 / 1002 (0.30%)
    2 / 998 (0.20%)
         occurrences all number
    3
    2
    Functional gastrointestinal disorder
         subjects affected / exposed
    4 / 1002 (0.40%)
    1 / 998 (0.10%)
         occurrences all number
    4
    1
    Haematochezia
         subjects affected / exposed
    1 / 1002 (0.10%)
    3 / 998 (0.30%)
         occurrences all number
    1
    4
    Gastrointestinal disorder
         subjects affected / exposed
    3 / 1002 (0.30%)
    1 / 998 (0.10%)
         occurrences all number
    4
    1
    Enteritis
         subjects affected / exposed
    1 / 1002 (0.10%)
    2 / 998 (0.20%)
         occurrences all number
    1
    2
    Flatulence
         subjects affected / exposed
    3 / 1002 (0.30%)
    0 / 998 (0.00%)
         occurrences all number
    4
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    2 / 1002 (0.20%)
    0 / 998 (0.00%)
         occurrences all number
    2
    0
    Abdominal pain
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences all number
    0
    1
    Abdominal tenderness
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences all number
    0
    1
    Dry mouth
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences all number
    0
    1
    Gingival cyst
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences all number
    0
    1
    Infantile colic
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences all number
    0
    1
    Inguinal hernia
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences all number
    0
    1
    Mucous stools
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences all number
    1
    0
    Dyschezia
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences all number
    1
    0
    Regurgitation
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences all number
    0
    1
    Mouth ulceration
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences all number
    0
    1
    Dyspepsia
         subjects affected / exposed
    7 / 1002 (0.70%)
    9 / 998 (0.90%)
         occurrences all number
    7
    9
    Hepatobiliary disorders
    Liver injury
         subjects affected / exposed
    3 / 1002 (0.30%)
    4 / 998 (0.40%)
         occurrences all number
    3
    4
    Hepatic function abnormal
         subjects affected / exposed
    2 / 1002 (0.20%)
    1 / 998 (0.10%)
         occurrences all number
    2
    1
    Hypercholia
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences all number
    0
    1
    Cholestasis
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    18 / 1002 (1.80%)
    17 / 998 (1.70%)
         occurrences all number
    18
    19
    Rash
         subjects affected / exposed
    4 / 1002 (0.40%)
    6 / 998 (0.60%)
         occurrences all number
    4
    6
    Dermatitis allergic
         subjects affected / exposed
    1 / 1002 (0.10%)
    2 / 998 (0.20%)
         occurrences all number
    1
    2
    Eczema asteatotic
         subjects affected / exposed
    1 / 1002 (0.10%)
    1 / 998 (0.10%)
         occurrences all number
    1
    1
    Dermatitis atopic
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences all number
    0
    1
    Eczema infantile
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences all number
    0
    1
    Pityriasis
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences all number
    0
    1
    Rash erythematous
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences all number
    0
    1
    Seborrhoeic dermatitis
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences all number
    0
    1
    Dermatitis diaper
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences all number
    1
    0
    Purpura
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences all number
    1
    0
    Rash papular
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences all number
    1
    0
    Endocrine disorders
    Transient neonatal hyperthyrotropinaemia
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences all number
    0
    1
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    6 / 1002 (0.60%)
    2 / 998 (0.20%)
         occurrences all number
    6
    2
    Upper respiratory tract infection
         subjects affected / exposed
    45 / 1002 (4.49%)
    46 / 998 (4.61%)
         occurrences all number
    55
    48
    Bronchitis
         subjects affected / exposed
    14 / 1002 (1.40%)
    13 / 998 (1.30%)
         occurrences all number
    14
    13
    Pharyngitis
         subjects affected / exposed
    9 / 1002 (0.90%)
    14 / 998 (1.40%)
         occurrences all number
    9
    15
    Nasopharyngitis
         subjects affected / exposed
    9 / 1002 (0.90%)
    8 / 998 (0.80%)
         occurrences all number
    9
    8
    Gastroenteritis
         subjects affected / exposed
    7 / 1002 (0.70%)
    8 / 998 (0.80%)
         occurrences all number
    7
    8
    Respiratory tract infection
         subjects affected / exposed
    219 / 1002 (21.86%)
    181 / 998 (18.14%)
         occurrences all number
    255
    203
    Laryngitis
         subjects affected / exposed
    4 / 1002 (0.40%)
    4 / 998 (0.40%)
         occurrences all number
    4
    4
    Candida infection
         subjects affected / exposed
    1 / 1002 (0.10%)
    2 / 998 (0.20%)
         occurrences all number
    1
    2
    Influenza
         subjects affected / exposed
    2 / 1002 (0.20%)
    1 / 998 (0.10%)
         occurrences all number
    2
    1
    Rhinitis
         subjects affected / exposed
    2 / 1002 (0.20%)
    1 / 998 (0.10%)
         occurrences all number
    2
    1
    Conjunctivitis
         subjects affected / exposed
    0 / 1002 (0.00%)
    2 / 998 (0.20%)
         occurrences all number
    0
    2
    Cytomegalovirus infection
         subjects affected / exposed
    0 / 1002 (0.00%)
    2 / 998 (0.20%)
         occurrences all number
    0
    2
    Oral candidiasis
         subjects affected / exposed
    0 / 1002 (0.00%)
    2 / 998 (0.20%)
         occurrences all number
    0
    2
    Adenovirus infection
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences all number
    1
    0
    Acute sinusitis
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences all number
    1
    0
    Sinusitis
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences all number
    0
    1
    Mycoplasma infection
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences all number
    0
    1
    Herpangina
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences all number
    0
    1
    Gastrointestinal infection
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences all number
    0
    1
    Exanthema subitum
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences all number
    0
    1
    Eczema infected
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences all number
    0
    1
    Diarrhoea infectious
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences all number
    0
    1
    Dermatitis infected
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences all number
    0
    1
    Dacryocystitis
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences all number
    0
    1
    Bronchiolitis
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences all number
    0
    1
    Gastroenteritis rotavirus
         subjects affected / exposed
    2 / 1002 (0.20%)
    0 / 998 (0.00%)
         occurrences all number
    2
    0
    Rhinovirus infection
         subjects affected / exposed
    1 / 1002 (0.10%)
    1 / 998 (0.10%)
         occurrences all number
    1
    1
    Chlamydial infection
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences all number
    1
    0
    Otitis media
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences all number
    1
    0
    Hand-foot-and-mouth disease
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences all number
    1
    0
    Enterobacter infection
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences all number
    1
    0
    Conjunctivitis bacterial
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    102 / 1002 (10.18%)
    91 / 998 (9.12%)
         occurrences all number
    114
    104
    Electrolyte imbalance
         subjects affected / exposed
    8 / 1002 (0.80%)
    4 / 998 (0.40%)
         occurrences all number
    8
    5
    Hyperlactacidaemia
         subjects affected / exposed
    3 / 1002 (0.30%)
    1 / 998 (0.10%)
         occurrences all number
    3
    1
    Hyperkalaemia
         subjects affected / exposed
    0 / 1002 (0.00%)
    3 / 998 (0.30%)
         occurrences all number
    0
    3
    Hypercalcaemia
         subjects affected / exposed
    1 / 1002 (0.10%)
    2 / 998 (0.20%)
         occurrences all number
    1
    2
    Lactic acidosis
         subjects affected / exposed
    0 / 1002 (0.00%)
    1 / 998 (0.10%)
         occurrences all number
    0
    1
    Dehydration
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences all number
    1
    0
    Vitamin K deficiency
         subjects affected / exposed
    1 / 1002 (0.10%)
    0 / 998 (0.00%)
         occurrences all number
    1
    0
    Acid-base balance disorder mixed
         subjects affected / exposed
    1 / 1002 (0.10%)
    1 / 998 (0.10%)
         occurrences all number
    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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