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    Clinical Trial Results:
    A phase III, open-label, randomized, controlled study to evaluate the immunogenicity and safety of inactivated poliovirus vaccine (IPV) when co-administered with Porcine circovirus (PCV)-free liquid formulation of an oral live attenuated human rotavirus (HRV) vaccine in healthy Chinese infants.

    Summary
    EudraCT number
    		 2022-000708-36
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    22 Oct 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Oct 2025
    First version publication date
    23 Oct 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    218485
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT06331156
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    79 New Oxford Street, London, WC1A 1DG,, United Kingdom, TW8 9GS
    Public contact
    GSK Response Center, GSK Response Center, 44 8664357343, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 44 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
    07 May 2025
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 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 and safety of inactivated poliovirus vaccine (IPV) when co-administered with GSK's HRV PCV-free vaccine in healthy Chinese infants.
    Protection of trial subjects
    Study 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
    22 Mar 2024
    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: 400
    Worldwide total number of subjects
    400
    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)
    400
    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
    		 A total of 400 participants were included in Enrolled set, out of which only 392 were included in Exposed set and started the study.

    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
    		 Staggered Group
    Arm description
    		 Participants received 2 doses of Porcine circovirus (PCV)-free liquid formulation of GSK’s oral live attenuated human rotavirus (HRV) vaccine at Day 1 and Month 1, and 3 doses of Inactivated poliovirus vaccine (IPV) vaccine administered at Month 0.5, Month 1.5, and Month 2.5.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Inactivated Poliomyelitis Vaccine (IPV)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses per participant

    Investigational medicinal product name
    Rotarix PCV-free (HRV PCV-free)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    2 doses per participant

    Arm title
    		 Co-administration Group
    Arm description
    		 Participants received 2 doses of PCV-free liquid formulation of GSK’s oral live attenuated HRV vaccine co-administered with the first 2 doses of IPV vaccine at Month 0.5 and Month 1.5, followed by the third dose of IPV vaccine administered at Month 2.5.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Rotarix PCV-free (HRV PCV-free)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral liquid
    Routes of administration
    Oral use
    Dosage and administration details
    2 doses per participant

    Investigational medicinal product name
    Inactivated Poliomyelitis Vaccine (IPV)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses per participant

    Number of subjects in period 1 [1]
    		Staggered Group Co-administration Group
    Started
    199
    193
    Completed
    186
    189
    Not completed
    13
    4
         Adverse event, non-fatal
    1
    -
         Other
    7
    -
         Lost to follow-up
    1
    -
         Migrated / Moved from the study area
    4
    3
         Adverse event requiring expedited reporting
    -
    1
    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: Number of participants enrolled were 400 out of which only 392 participants started the study and were considered as the Exposed set.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Staggered Group
    Reporting group description
    		 Participants received 2 doses of Porcine circovirus (PCV)-free liquid formulation of GSK’s oral live attenuated human rotavirus (HRV) vaccine at Day 1 and Month 1, and 3 doses of Inactivated poliovirus vaccine (IPV) vaccine administered at Month 0.5, Month 1.5, and Month 2.5.

    Reporting group title
    Co-administration Group
    Reporting group description
    		 Participants received 2 doses of PCV-free liquid formulation of GSK’s oral live attenuated HRV vaccine co-administered with the first 2 doses of IPV vaccine at Month 0.5 and Month 1.5, followed by the third dose of IPV vaccine administered at Month 2.5.

    Reporting group values
    		 Staggered Group Co-administration Group Total
    Number of subjects
    		 199 193 392
    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)
    		 199 193 392
        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
    		 103 101 204
        FEMALE
    		 96 92 188
    Race/Ethnicity, Customized
    Units: Subjects
        ASIAN
    		 199 193 392

    End points

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    End points reporting groups
    Reporting group title
    Staggered Group
    Reporting group description
    		 Participants received 2 doses of Porcine circovirus (PCV)-free liquid formulation of GSK’s oral live attenuated human rotavirus (HRV) vaccine at Day 1 and Month 1, and 3 doses of Inactivated poliovirus vaccine (IPV) vaccine administered at Month 0.5, Month 1.5, and Month 2.5.

    Reporting group title
    Co-administration Group
    Reporting group description
    		 Participants received 2 doses of PCV-free liquid formulation of GSK’s oral live attenuated HRV vaccine co-administered with the first 2 doses of IPV vaccine at Month 0.5 and Month 1.5, followed by the third dose of IPV vaccine administered at Month 2.5.

    Primary: Percentage of participants with seroconversion for anti-poliovirus types 1, 2 and 3 neutralizing antibody (Ab)

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    End point title
    		 Percentage of participants with seroconversion for anti-poliovirus types 1, 2 and 3 neutralizing antibody (Ab)
    End point description
    Seroconversion for anti-poliovirus types 1, 2 and 3 neutralizing Ab is defined as: - Ab titer greater than or equal to (>=) 1:8 at 1 month after the 3 dose primary vaccination schedule of IPV in participants with Ab titer lower than (<) 1:8 at pre-vaccination, >= 4-fold increase in Ab titer at 1 month after the 3 dose primary vaccination schedule of IPV in participants with Ab titer >= 1:8 at pre-vaccination. Analysis was performed on the per protocol set (PPS) for IPV, comprising participants who adhered to their assigned intervention schedule without conditions affecting immunogenicity or using prohibited treatments. For anti-poliovirus types 1, 2, and 3 at 1 month post-Dose 3, participants must have pre- and post-vaccination immunogenicity data for at least one antigen and adhered to the interval between Dose 3 and blood sample at the specified timepoint.
    End point type
    Primary
    End point timeframe
    At Month 3.5 (1 month post-Dose 3 of IPV)
    End point values
    		 Staggered Group Co-administration Group
    Number of subjects analysed
    125
    143
    Units: Percentage of participants
    number (confidence interval 95%)
        anti-poliovirus serotype1
    99.2 (95.6 to 100)
    99.3 (96.2 to 100)
        anti-poliovirus serotype2
    100 (97.1 to 100)
    99.3 (96.2 to 100)
        anti-poliovirus serotype3
    100 (97.1 to 100)
    100 (97.5 to 100)
    Statistical analysis title
    		 Between-group analysis
    Statistical analysis description
    To demonstrate the immunological non-inferiority of IPV when co-administered with HRV PCV-free compared with IPV administered alone in terms of seroconversion rates 1-month post-Dose 3 of IPV (Month 3.5).
    Comparison groups
    Staggered Group v Co-administration Group
    Number of subjects included in analysis
    268
    Analysis specification
    Pre-specified
    Analysis type
    		 [1]
    Method
    Parameter type
    		 Difference in seroconversion rate
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.14
         upper limit
    		 3.76
    Notes
    [1] - Non-inferiority (NI) was to be demonstrated if the lower limit (LL) of the 2-sided 95% confidence interval (CI) for the group difference (Co-administration group minus Staggered group) in seroconversion rate is greater than or equal to (>=) -10% for the anti-poliovirus type 1 antibodies.
    Statistical analysis title
    		 Between-group analysis
    Statistical analysis description
    To demonstrate the immunological non-inferiority of IPV when co-administered with HRV PCV-free compared with IPV administered alone in terms of seroconversion rates 1-month post-Dose 3 of IPV (Month 3.5).
    Comparison groups
    Staggered Group v Co-administration Group
    Number of subjects included in analysis
    268
    Analysis specification
    Pre-specified
    Analysis type
    		 [2]
    Method
    Parameter type
    		 Difference in seroconversion rate
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.63
         upper limit
    		 2.99
    Notes
    [2] - NI was to be demonstrated if the LL of the 2-sided 95% CI for the group difference (Co-administration group minus Staggered group) in seroconversion rate is >= -10% for the anti-poliovirus type 3 antibodies.
    Statistical analysis title
    		 Between-group analysis
    Statistical analysis description
    To demonstrate the immunological non-inferiority of IPV when co-administered with HRV PCV-free compared with IPV administered alone in terms of seroconversion rates 1-month post-Dose 3 of IPV (Month 3.5).
    Comparison groups
    Staggered Group v Co-administration Group
    Number of subjects included in analysis
    268
    Analysis specification
    Pre-specified
    Analysis type
    		 [3]
    Method
    Parameter type
    		 Difference in seroconversion rate
    Point estimate
    -0.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.86
         upper limit
    		 2.3
    Notes
    [3] - NI was to be demonstrated if the LL of the 2-sided 95% CI for the group difference (Co-administration group minus Staggered group) in seroconversion rate is >= -10% for the anti-poliovirus type 2 antibodies.

    Secondary: Geometric mean titers (GMTs) of anti-poliovirus types 1, 2 and 3 neutralizing Ab

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    End point title
    		 Geometric mean titers (GMTs) of anti-poliovirus types 1, 2 and 3 neutralizing Ab
    End point description
    Analysis was performed on the PPS for IPV. Only participants with data available at the specified timepoints were included in the analysis.
    End point type
    Secondary
    End point timeframe
    At Month 3.5 (1 month post-Dose 3 of IPV)
    End point values
    		 Staggered Group Co-administration Group
    Number of subjects analysed
    125
    143
    Units: Titers
    arithmetic mean (confidence interval 95%)
        anti-poliovirus serotype1
    1369.71 (1140.65 to 1644.78)
    1374.44 (1148.21 to 1645.25)
        anti-poliovirus serotype2
    194.95 (168.13 to 226.06)
    190.44 (164.90 to 219.94)
        anti-poliovirus serotype3
    451.36 (389.37 to 523.23)
    450.15 (395.92 to 511.79)
    No statistical analyses for this end point

    Secondary: Percentage of participants with anti-poliovirus types 1, 2 and 3 neutralizing Ab titers >=1:8 and >=1:64

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    End point title
    		 Percentage of participants with anti-poliovirus types 1, 2 and 3 neutralizing Ab titers >=1:8 and >=1:64
    End point description
    Analysis was performed on the PPS for IPV. Only participants with data available at the specified timepoints were included in the analysis.
    End point type
    Secondary
    End point timeframe
    At Month 3.5 (1 month post-Dose 3 of IPV)
    End point values
    		 Staggered Group Co-administration Group
    Number of subjects analysed
    125
    143
    Units: Percentage of participants
    number (confidence interval 95%)
        anti-poliovirus serotype1, Percentage (%) >= 8
    100 (97.1 to 100)
    100 (97.5 to 100)
        anti-poliovirus serotype1, % >= 64
    100 (97.1 to 100)
    100 (97.5 to 100)
        anti-poliovirus serotype2, % >= 8
    100 (97.1 to 100)
    100 (97.5 to 100)
        anti-poliovirus serotype2, % >= 64
    91.2 (84.8 to 95.5)
    91.6 (85.8 to 95.6)
        anti-poliovirus serotype3, % >= 8
    100 (97.1 to 100)
    100 (97.5 to 100)
        anti-poliovirus serotype3, % >= 64
    98.4 (94.3 to 99.8)
    99.3 (96.2 to 100)
    No statistical analyses for this end point

    Secondary: Percentage of participants with seroconversion for anti-rotavirus (RV) immunoglobulin A (IgA) Ab

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    End point title
    		 Percentage of participants with seroconversion for anti-rotavirus (RV) immunoglobulin A (IgA) Ab
    End point description
    Seroconversion for anti-RV IgA Ab is defined as: anti-RV IgA Ab concentration >= 20 unit per milliliter (U/mL) at 1 month post-Dose 2 of HRV PCV-free vaccine, in participants who were initially seronegative (i.e., with anti-RV IgA Ab concentration < 20 U/mL prior to the first dose of HRV PCV-free vaccine). Analysis was performed on the PPS for RV, comprising participants who adhered to their assigned intervention schedule without conditions affecting immunogenicity or using prohibited treatments. For anti-RV IgA analyses at 1 month post Dose 2 of HRV PCV-free, participants should have pre- and post-vaccination immunogenicity results and should have complied with the interval between HRV Dose 2 and the post HRV PCV-free Dose 2 blood sample at the specified timepoint.
    End point type
    Secondary
    End point timeframe
    At 1 month post-Dose 2 of HRV PCV-free vaccine (Month 2 for Staggered Group and Month 2.5 for Co-administration Group)
    End point values
    		 Staggered Group Co-administration Group
    Number of subjects analysed
    130
    146
    Units: Percentage of participants
        number (confidence interval 95%)
    78.5 (70.4 to 85.2)
    90.4 (84.4 to 94.7)
    No statistical analyses for this end point

    Secondary: Geometric mean concentrations (GMCs) of Anti-RV IgA Ab

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    End point title
    		 Geometric mean concentrations (GMCs) of Anti-RV IgA Ab
    End point description
    Analysis was performed on the PPS for RV. Only participants with data available at the specified timepoints were included in the analysis.
    End point type
    Secondary
    End point timeframe
    At 1 month post-Dose 2 of HRV PCV-free vaccine (Month 2 for Staggered Group and Month 2.5 for Co-administration Group)
    End point values
    		 Staggered Group Co-administration Group
    Number of subjects analysed
    130
    146
    Units: U/mL
        arithmetic mean (confidence interval 95%)
    160.59 (114.49 to 225.25)
    222.15 (165.98 to 297.34)
    No statistical analyses for this end point

    Secondary: Number of participants reporting any solicited systemic events

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    End point title
    		 Number of participants reporting any solicited systemic events
    End point description
    Solicited systemic events include cough/runny nose, diarrhoea, fever (pyrexia), irritability/fussiness, loss of appetite and vomiting. 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 who received at least one dose of any of the 2 study interventions and for whom solicited systemic events data were available after the corresponding vaccination for the specified timepoint.
    End point type
    Secondary
    End point timeframe
    Within 14 days after Dose 1 & 2: HRV PCV-free vaccine administered at Day 1 & Month 1 (Staggered group) and at Month 0.5 & Month 1.5 (Co-administration group); IPV administered at Month 0.5 & Month 1.5 (Staggered and Co-administration group)
    End point values
    		 Staggered Group Co-administration Group
    Number of subjects analysed
    197
    193
    Units: Participants
        Cough, post vaccination at Day 1
    21
    0
        Cough, post vaccination at Month 0.5
    28
    27
        Cough, post vaccination at Month 1
    27
    0
        Cough, post vaccination at Month 1.5
    23
    22
        Diarrhea, post vaccination at Day 1
    8
    0
        Diarrhea, post vaccination at Month 0.5
    10
    9
        Diarrhea, post vaccination at Month 1
    11
    0
        Diarrhea, post vaccination at Month 1.5
    7
    12
        Fever, post vaccination at Day 1
    15
    0
        Fever, post vaccination at Month 0.5
    46
    23
        Fever, post vaccination at Month 1
    33
    0
        Fever, post vaccination at Month 1.5
    25
    21
        Irritability, post vaccination at Day 1
    15
    0
        Irritability, post vaccination at Month 0.5
    11
    19
        Irritability, post vaccination at Month 1
    6
    0
        Irritability, post vaccination at Month 1.5
    6
    7
        Loss of appetite, post vaccination at Day 1
    14
    0
        Loss of appetite, post vaccination at Month 0.5
    10
    20
        Loss of appetite, post vaccination at Month 1
    5
    0
        Loss of appetite, post vaccination at Month 1.5
    5
    4
        Vomiting, post vaccination at Day 1
    12
    0
        Vomiting, post vaccination at Month 0.5
    6
    18
        Vomiting, post vaccination at Month 1
    6
    0
        Vomiting, post vaccination at Month 1.5
    1
    7
    No statistical analyses for this end point

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

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    End point title
    		 Percentage of participants with anti-RV IgA Ab concentrations >= 90 U/mL
    End point description
    Analysis was performed on the PPS for RV. Only participants with data available at the specified timepoints were included in the analysis.
    End point type
    Secondary
    End point timeframe
    At 1 month post-Dose 2 of HRV PCV-free vaccine (Month 2 for Staggered Group and Month 2.5 for Co-administration Group)
    End point values
    		 Staggered Group Co-administration Group
    Number of subjects analysed
    130
    146
    Units: Percentage of participants
        number (confidence interval 95%)
    63.8 (55.0 to 72.1)
    68.5 (60.3 to 75.9)
    No statistical analyses for this end point

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

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    End point title
    		 Number of participants reporting any 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 who received at least one dose of any of the 2 study interventions 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 after each dose of HRV PCV-free vaccine (administered at Day 1 and Month 1 for Staggered Group and at Month 0.5 and Month 1.5 for Co-administration group)
    End point values
    		 Staggered Group Co-administration Group
    Number of subjects analysed
    199
    193
    Units: Participants
        HRV PCV-free: post-Dose 1
    38
    45
        HRV PCV-free: post-Dose 2
    39
    34
    No statistical analyses for this end point

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

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    End point title
    		 Number of participants reporting any 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 per medical or scientific judgment. 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 who received at least one dose of any of the 2 study interventions and for whom SAE data were available after the corresponding vaccinations for the specified duration.
    End point type
    Secondary
    End point timeframe
    From the first dose of the study intervention (Day 1 for Staggered group and Month 0.5 for Co-administration group) up to study end (Month 3.5)
    End point values
    		 Staggered Group Co-administration Group
    Number of subjects analysed
    199
    193
    Units: Participants
    30
    30
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited AEs: From Day 1 to Day 14 after any vaccination and unsolicited AEs: Day 1 to Day 31 after any vaccination. All-cause mortality and SAEs were collected throughout the study period (From Day 1 to Month 3.5).
    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
    v27.1
    Reporting groups
    Reporting group title
    Co-administration Group
    Reporting group description
    		 Participants received 2 doses of PCV-free liquid formulation of GSK’s oral live attenuated HRV vaccine co-administered with the first 2 doses of IPV vaccine at Month 0.5 and Month 1.5, followed by the third dose of IPV vaccine administered at Month 2.5.

    Reporting group title
    Staggered Group
    Reporting group description
    		 Participants received 2 doses of Porcine circovirus (PCV)-free liquid formulation of GSK’s oral live attenuated human rotavirus (HRV) vaccine at Day 1 and Month 1, and 3 doses of Inactivated poliovirus vaccine (IPV) vaccine administered at Month 0.5, Month 1.5, and Month 2.5.

    Serious adverse events
    		 Co-administration Group Staggered Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    30 / 193 (15.54%)
    30 / 199 (15.08%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Cardiac disorders
    Myocardial injury
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure acute
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Secondary thrombocytosis
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 199 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Functional gastrointestinal disorder
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 199 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 199 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 199 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Pelvi-ureteric obstruction
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 199 (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
    Pneumonia
         subjects affected / exposed
    16 / 193 (8.29%)
    17 / 199 (8.54%)
         occurrences causally related to treatment / all
    0 / 17
    0 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 199 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Exanthema subitum
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 199 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia mycoplasmal
         subjects affected / exposed
    0 / 193 (0.00%)
    2 / 199 (1.01%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile infection
         subjects affected / exposed
    5 / 193 (2.59%)
    4 / 199 (2.01%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pertussis
         subjects affected / exposed
    2 / 193 (1.04%)
    0 / 199 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngitis
         subjects affected / exposed
    0 / 193 (0.00%)
    3 / 199 (1.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 193 (0.52%)
    2 / 199 (1.01%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 193 (1.04%)
    3 / 199 (1.51%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    1 / 193 (0.52%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial infection
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 199 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 199 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia escherichia
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 199 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Co-administration Group Staggered Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    129 / 193 (66.84%)
    141 / 199 (70.85%)
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    48 / 193 (24.87%)
    66 / 199 (33.17%)
         occurrences all number
    49
    74
    Reproductive system and breast disorders
    Testicular swelling
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 199 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    11 / 193 (5.70%)
    4 / 199 (2.01%)
         occurrences all number
    11
    4
    Rhinorrhoea
         subjects affected / exposed
    7 / 193 (3.63%)
    3 / 199 (1.51%)
         occurrences all number
    7
    3
    Nasal obstruction
         subjects affected / exposed
    2 / 193 (1.04%)
    5 / 199 (2.51%)
         occurrences all number
    2
    6
    Nasal congestion
         subjects affected / exposed
    2 / 193 (1.04%)
    1 / 199 (0.50%)
         occurrences all number
    2
    1
    Asthma
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 199 (0.00%)
         occurrences all number
    1
    0
    Productive cough
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 199 (0.00%)
         occurrences all number
    1
    0
    Dyspnoea
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 199 (0.50%)
         occurrences all number
    0
    1
    Increased upper airway secretion
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 199 (0.50%)
         occurrences all number
    0
    1
    Investigations
    Myocardial necrosis marker increased
         subjects affected / exposed
    3 / 193 (1.55%)
    1 / 199 (0.50%)
         occurrences all number
    3
    1
    Injury, poisoning and procedural complications
    Head injury
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 199 (0.00%)
         occurrences all number
    1
    0
    Arthropod bite
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 199 (0.50%)
         occurrences all number
    0
    1
    Cardiac disorders
    Myocardial injury
         subjects affected / exposed
    2 / 193 (1.04%)
    2 / 199 (1.01%)
         occurrences all number
    2
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 193 (0.52%)
    2 / 199 (1.01%)
         occurrences all number
    1
    2
    Eosinophilia
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 199 (0.00%)
         occurrences all number
    1
    0
    Coagulopathy
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 199 (0.50%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    6 / 193 (3.11%)
    1 / 199 (0.50%)
         occurrences all number
    6
    1
    Constipation
         subjects affected / exposed
    7 / 193 (3.63%)
    6 / 199 (3.02%)
         occurrences all number
    7
    7
    Dyspepsia
         subjects affected / exposed
    2 / 193 (1.04%)
    1 / 199 (0.50%)
         occurrences all number
    2
    2
    Abdominal distension
         subjects affected / exposed
    1 / 193 (0.52%)
    1 / 199 (0.50%)
         occurrences all number
    1
    1
    Functional gastrointestinal disorder
         subjects affected / exposed
    1 / 193 (0.52%)
    1 / 199 (0.50%)
         occurrences all number
    1
    1
    Enteritis
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 199 (0.00%)
         occurrences all number
    1
    0
    Intestinal obstruction
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 199 (0.00%)
         occurrences all number
    1
    0
    Colitis
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 199 (0.50%)
         occurrences all number
    0
    1
    Hepatobiliary disorders
    Liver injury
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 199 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    3 / 193 (1.55%)
    6 / 199 (3.02%)
         occurrences all number
    3
    6
    Eczema
         subjects affected / exposed
    2 / 193 (1.04%)
    7 / 199 (3.52%)
         occurrences all number
    2
    9
    Dermatitis allergic
         subjects affected / exposed
    0 / 193 (0.00%)
    2 / 199 (1.01%)
         occurrences all number
    0
    2
    Eczema infantile
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 199 (0.50%)
         occurrences all number
    0
    1
    Rash papular
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 199 (0.50%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Ureteric dilatation
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 199 (0.00%)
         occurrences all number
    1
    0
    Nephrolithiasis
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 199 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    9 / 193 (4.66%)
    7 / 199 (3.52%)
         occurrences all number
    9
    8
    Respiratory tract infection
         subjects affected / exposed
    29 / 193 (15.03%)
    51 / 199 (25.63%)
         occurrences all number
    30
    62
    Pharyngitis
         subjects affected / exposed
    2 / 193 (1.04%)
    6 / 199 (3.02%)
         occurrences all number
    2
    6
    Oral candidiasis
         subjects affected / exposed
    1 / 193 (0.52%)
    2 / 199 (1.01%)
         occurrences all number
    1
    2
    Gastroenteritis
         subjects affected / exposed
    0 / 193 (0.00%)
    2 / 199 (1.01%)
         occurrences all number
    0
    2
    Candida infection
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 199 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal infection
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 199 (0.00%)
         occurrences all number
    1
    0
    Bacterial infection
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 199 (0.50%)
         occurrences all number
    0
    1
    Conjunctivitis
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 199 (0.50%)
         occurrences all number
    0
    1
    Conjunctivitis viral
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 199 (0.50%)
         occurrences all number
    0
    1
    Herpes simplex
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 199 (0.50%)
         occurrences all number
    0
    1
    Pneumonia
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 199 (0.50%)
         occurrences all number
    0
    1
    Bronchitis
         subjects affected / exposed
    1 / 193 (0.52%)
    4 / 199 (2.01%)
         occurrences all number
    1
    4
    Nasopharyngitis
         subjects affected / exposed
    2 / 193 (1.04%)
    4 / 199 (2.01%)
         occurrences all number
    2
    4
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    0 / 193 (0.00%)
    2 / 199 (1.01%)
         occurrences all number
    0
    2
    Electrolyte imbalance
         subjects affected / exposed
    0 / 193 (0.00%)
    2 / 199 (1.01%)
         occurrences all number
    0
    2
    Decreased appetite
         subjects affected / exposed
    2 / 193 (1.04%)
    0 / 199 (0.00%)
         occurrences all number
    2
    0
    Hypercalcaemia
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 199 (0.00%)
         occurrences all number
    1
    0
    Hyperkalaemia
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 199 (0.00%)
         occurrences all number
    1
    0
    Lactose intolerance
         subjects affected / exposed
    1 / 193 (0.52%)
    0 / 199 (0.00%)
         occurrences all number
    1
    0
    Lactic acidosis
         subjects affected / exposed
    0 / 193 (0.00%)
    1 / 199 (0.50%)
         occurrences all number
    0
    1

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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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