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    Clinical Trial Results:
    A phase IV, single-blind, randomised, controlled, multi-country study to evaluate the immunogenicity and safety of GSK’s Infanrix hexa (DTPa-HBV-IPV/Hib) versus MCM Vaccine BV’s Vaxelis (DTaP5 HBV IPV Hib), when administered intramuscularly according to a 2 , 4 and 12 month schedule in healthy infants and toddlers.

    Summary
    EudraCT number
    		 2019-002988-10
    Trial protocol
    		 DE   IT  
    Global end of trial date
    10 Nov 2022

    Results information
    Results version number
    		 v2(current)
    This version publication date
    01 Jun 2024
    First version publication date
    24 May 2023
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    212645
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04535037
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals SA
    Sponsor organisation address
    Rue de l'Institut 89, Rixensart, Belgium, B-1330
    Public contact
    GSK Response Center, GlaxoSmithKline Biologicals SA, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, GlaxoSmithKline Biologicals SA, 044 2089-904466, 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
    12 Jan 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Nov 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that the Hib response in DTPa-HBV-IPV/Hib investigational group is non-inferior to DTaP5 HBV IPV Hib comparator group, 1-month post-booster vaccination in terms of geometric mean concentrations (GMCs) and percentage of subjects with anti-polyribosylribitol phosphate (PRP) antibody concentrations equal to or above (≥) 5 microgram per milliliter (μg/mL). To demonstrate that the Hib response in DTPa-HBV-IPV/Hib investigational group is superior to DTaP5 HBV IPV Hib comparator group, 1 month post-booster vaccination in terms of GMCs and percentage of subjects with anti-PRP antibody concentrations ≥5 μg/mL.A hierarchical procedure is used to these primary objectives.
    Protection of trial subjects
    Subjects must be observed closely for at least 30 minutes after the administration of the vaccines. Appropriate medical treatment must be readily available during the observation period in case of anaphylaxis and/or syncope. Vaccines/products will be administered by qualified and trained personnel. Vaccines/products will be administered only to eligible participants who have no contraindications to any components of the vaccines/products. Participants will be followed-up for 31 days after the last vaccination/product administration.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Feb 2021
    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
    Germany: 150
    Country: Number of subjects enrolled
    Italy: 20
    Country: Number of subjects enrolled
    Spain: 330
    Worldwide total number of subjects
    500
    EEA total number of subjects
    500
    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)
    500
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 500 participants were enrolled in the study.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind [1]
    Roles blinded
    		 Subject, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Infanrix Hexa
    Arm description
    		 All subjects in this group received 3 doses (2 primary doses and 1 booster dose) of DTPa-HBV-IPV/Hib vaccine co-administered with 3 doses of pneumococcal 13 valent conjugate vaccine at 2, 4, and 12 months of age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Infanrix hexa
    Investigational medicinal product code
    Other name
    DTPa-HBV-IPV/Hib
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses (1 each at 2, 4 and 12 months of age) of Infanrix hexa vaccine administered by intramuscular injection into the right thigh.

    Investigational medicinal product name
    Prevenar 13
    Investigational medicinal product code
    Other name
    Pneumococcal 13 valent conjugate vaccine
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses (1 each at 2, 4 and 12 months of age) of pneumococcal 13 valent conjugate vaccine administered by intramuscular injection into the left thigh.

    Arm title
    		 Vaxelis
    Arm description
    		 All subjects in this group received 3 doses (2 primary doses and 1 booster dose) of DTaP5 HBV IPV Hib vaccine co-administered with 3 doses of pneumococcal 13 valent conjugate vaccine at 2, 4, and 12 months of age.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Prevenar 13
    Investigational medicinal product code
    Other name
    Pneumococcal 13 valent conjugate vaccine
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses (1 each at 2, 4 and 12 months of age) of pneumococcal 13 valent conjugate vaccine administered by intramuscular injection into the left thigh.

    Investigational medicinal product name
    Vaxelis
    Investigational medicinal product code
    Other name
    DTaP5 HBV IPV Hib
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    3 doses (1 each at 2, 4 and 12 months of age) of DTaP5 HBV IPV Hib vaccine administered by intramuscular injection into the right thigh.

    Notes
    [1] - The number of roles blinded appears inconsistent with a single blinded trial. It is expected that there will be one role blinded in a single blind trial.
    Justification: As per protocol, despite the fact that this is a single-blind study, the data management and biostatistics teams will remain blinded to the study treatment until after the final database lock.
    Number of subjects in period 1
    		Infanrix Hexa Vaxelis
    Started
    249
    251
    Completed
    237
    233
    Not completed
    12
    18
         Consent withdrawn by subject
    8
    9
         Migrated / moved from the study area
    1
    4
         Unspecified
    2
    5
         Protocol deviation
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Infanrix Hexa
    Reporting group description
    		 All subjects in this group received 3 doses (2 primary doses and 1 booster dose) of DTPa-HBV-IPV/Hib vaccine co-administered with 3 doses of pneumococcal 13 valent conjugate vaccine at 2, 4, and 12 months of age.

    Reporting group title
    Vaxelis
    Reporting group description
    		 All subjects in this group received 3 doses (2 primary doses and 1 booster dose) of DTaP5 HBV IPV Hib vaccine co-administered with 3 doses of pneumococcal 13 valent conjugate vaccine at 2, 4, and 12 months of age.

    Reporting group values
    		 Infanrix Hexa Vaxelis Total
    Number of subjects
    		 249 251 500
    Age categorical
    Units: Participants
        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)
    		 249 251 500
        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
    Age Continuous
    Units: Weeks
        arithmetic mean (standard deviation)
    		 8.6 ± 1.17 8.6 ± 1.24 -
    Sex: Female, Male
    Units: Participants
        Female
    		 105 135 240
        Male
    		 144 116 260
    Race/Ethnicity, Customized
    Units: Subjects
        Black or African American
    		 1 2 3
        American Indian or Alaska Native
    		 1 2 3
        Asian - Central / South Asian Heritage
    		 0 1 1
        Asian - East Asian Heritage
    		 1 0 1
        Asian - South East Asian Heritage
    		 0 1 1
        White - Arabic / North African Heritage
    		 5 4 9
        White - Caucasian / European Heritage
    		 236 235 471
        Other-Unspecified
    		 5 6 11

    End points

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    End points reporting groups
    Reporting group title
    Infanrix Hexa
    Reporting group description
    		 All subjects in this group received 3 doses (2 primary doses and 1 booster dose) of DTPa-HBV-IPV/Hib vaccine co-administered with 3 doses of pneumococcal 13 valent conjugate vaccine at 2, 4, and 12 months of age.

    Reporting group title
    Vaxelis
    Reporting group description
    		 All subjects in this group received 3 doses (2 primary doses and 1 booster dose) of DTaP5 HBV IPV Hib vaccine co-administered with 3 doses of pneumococcal 13 valent conjugate vaccine at 2, 4, and 12 months of age.

    Primary: Anti-polyribosylribitol phosphate (anti-PRP) antibody concentrations at Month 11, based on Per protocol set (PPS)

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    End point title
    		 Anti-polyribosylribitol phosphate (anti-PRP) antibody concentrations at Month 11, based on Per protocol set (PPS)
    End point description
    Anti-PRP antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in microgram per milliliter (μg/mL), as assessed by Enzyme-linked immunosorbent assay (ELISA). As specified in the Statistical Analysis Plan, for the co-primary objectives, only geometric mean was calculated for anti-PRP antibody concentration and was adjusted for DTPa vaccination of the mother (and thus, the 95% Confidence Interval [CI] is set as “9.999 to 9999”). The analysis was performed on the Per Protocol Set (PPS), which included all eligible subjects who received diphtheria, tetanus and acellular pertussis (DTPa)-combination study vaccines as per protocol, who had anti-PRP results post-vaccination, who complied with vaccination/blood draw intervals, without intercurrent conditions and without prohibited concomitant medication/vaccination and for whom immunogenicity data were available for specific timepoints.
    End point type
    Primary
    End point timeframe
    At Month 11 (i.e., 1-month post-booster vaccination)
    End point values
    		 Infanrix Hexa Vaxelis
    Number of subjects analysed
    211
    218
    Units: μg/mL
        geometric mean (confidence interval 95%)
    11.61 (9.999 to 9999)
    12.66 (9.999 to 9999)
    Statistical analysis title
    		 Non-inferiority of Infanrix Hexa vs Vaxelis
    Statistical analysis description
    Non-inferiority was demonstrated if the lower limit (LL) of the 2‑sided 95% CI on group GMC ratio (Infanrix Hexa over Vaxelis group) was above 0.5.
    Comparison groups
    Infanrix Hexa v Vaxelis
    Number of subjects included in analysis
    429
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Adjusted GMC Ratio
    Point estimate
    0.917
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.71
         upper limit
    		 1.185
    Notes
    [1] - The 95% CI for GMC ratio derived from an ANOVA model on log10 transformed concentration was used. GMC was adjusted for DTPA vaccination of the mother.

    Primary: Percentage of subjects with anti-PRP antibody concentrations equal to or above (≥) 5 µg/mL at Month 11, based on PPS

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    End point title
    		 Percentage of subjects with anti-PRP antibody concentrations equal to or above (≥) 5 µg/mL at Month 11, based on PPS
    End point description
    The percentage of subjects with anti-PRP antibody concentrations ≥5 µg/mL was reported, as assessed by ELISA. The analysis was performed on PPS, which included all eligible subjects who received all DTPa-combination study vaccines as per protocol, who had anti-PRP results post-vaccination, who complied with vaccination/blood draw intervals, without intercurrent conditions and without prohibited concomitant medication/vaccination.
    End point type
    Primary
    End point timeframe
    At Month 11 (i.e., 1-month post-booster vaccination)
    End point values
    		 Infanrix Hexa Vaxelis
    Number of subjects analysed
    211
    218
    Units: Percentage of Participants
        number (not applicable)
    75.4
    81.7
    Statistical analysis title
    		 Non-inferiority of Infanrix Hexa vs Vaxelis
    Statistical analysis description
    Non-inferiority was demonstrated if the non inferiority of anti-PRP GMC ratio was met and the LL of the 2 sided 95% CI on group difference in the percentage (Infanrix Hexa over Vaxelis group) was more than -10%.
    Comparison groups
    Infanrix Hexa v Vaxelis
    Number of subjects included in analysis
    429
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 Difference in Percentage
    Point estimate
    -6.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -14.1
         upper limit
    		 1.49
    Notes
    [2] - The 2 sided 95% CI of group difference in seroconversion rate (Inv_group minus Com_group) was computed based on Miettinen and Nurminen method.

    Primary: Anti-PRP antibody concentrations at Month 11, based on the Exposed Set (ES)

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    End point title
    		 Anti-PRP antibody concentrations at Month 11, based on the Exposed Set (ES) [3]
    End point description
    Anti-PRP antibody concentrations were presented as GMCs and expressed in μg/mL, as assessed by ELISA. As specified in the Statistical Analysis Plan, for the co-primary objectives, only geometric mean was calculated for anti-PRP antibody concentration and was adjusted for DTPa vaccination of the mother (and thus, the 95%CI is set as “9.999 to 9999”). The analysis was performed on the Exposed Set (ES), which included all vaccinated subjects who were analysed according to the intervention they received at Dose 1 and for whom immunogenicity data were available for specific timepoints.
    End point type
    Primary
    End point timeframe
    At Month 11 (i.e., 1-month post-booster vaccination)
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Infanrix Hexa Vaxelis
    Number of subjects analysed
    175
    228
    Units: μg/mL
        geometric mean (confidence interval 95%)
    11.26 (9.999 to 9999)
    12.85 (9.999 to 9999)
    No statistical analyses for this end point

    Primary: Percentage of subjects with anti-PRP antibody concentrations ≥ 5 µg/mL at Month 11, based on ES

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    End point title
    		 Percentage of subjects with anti-PRP antibody concentrations ≥ 5 µg/mL at Month 11, based on ES [4]
    End point description
    The percentage of subjects with anti-PRP antibody concentrations ≥5 µg/mL was reported, as assessed by ELISA. The analysis was performed on the ES, which included all vaccinated subjects who were analysed according to the intervention they receive at Dose 1.
    End point type
    Primary
    End point timeframe
    At Month 11 (i.e., 1-month post-booster vaccination)
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Infanrix Hexa Vaxelis
    Number of subjects analysed
    175
    186
    Units: Percentage of Participants
        number (not applicable)
    75.4
    81.6
    No statistical analyses for this end point

    Secondary: Percentage of subjects with anti-PRP antibody concentration ≥ 0.15 µg/mL

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    End point title
    		 Percentage of subjects with anti-PRP antibody concentration ≥ 0.15 µg/mL
    End point description
    The percentage of subjects with anti-PRP antibody concentration equal to or above the threshold for short-term protection was reported. The threshold for short-term protection is 0.15 µg/mL. The analysis was performed on PPS, which included all eligible subjects who received all DTPa-combination study vaccines as per protocol, who had anti-PRP results post-vaccination, who complied with vaccination/blood draw intervals, without intercurrent conditions and without prohibited concomitant medication/vaccination.
    End point type
    Secondary
    End point timeframe
    At Month 3 (i.e., 1-month post-primary vaccination), Month 10 (i.e., pre-booster) and Month 11 (i.e., 1-month post-booster vaccination)
    End point values
    		 Infanrix Hexa Vaxelis
    Number of subjects analysed
    213
    230
    Units: Percentage of Participants
    number (confidence interval 95%)
        At month 3 (N=213;230)
    79.8 (73.79 to 84.99)
    100 (98.41 to 100)
        At Month 10 (N=206;216)
    61.2 (54.14 to 67.86)
    94.4 (90.50 to 97.10)
        At Month 11 (N=211;218)
    99.5 (97.39 to 99.99)
    99.5 (97.47 to 99.99)
    No statistical analyses for this end point

    Secondary: Percentage of subjects with anti-PRP antibody concentrations ≥ 1.0 µg/mL

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    End point title
    		 Percentage of subjects with anti-PRP antibody concentrations ≥ 1.0 µg/mL
    End point description
    The percentage of subjects with anti-PRP antibody concentration equal to or above the threshold for long-term protection was reported. The threshold for long-term protection is 1.0 µg/mL. The analysis was performed on PPS, which included all eligible subjects who received all DTPa-combination study vaccines as per protocol, who had anti-PRP results post-vaccination, who complied with vaccination/blood draw intervals, without intercurrent conditions and without prohibited concomitant medication/vaccination.
    End point type
    Secondary
    End point timeframe
    At Month 3 (i.e., 1-month post-primary vaccination), Month 10 (i.e., pre-booster) and Month 11 (i.e., 1-month post-booster vaccination)
    End point values
    		 Infanrix Hexa Vaxelis
    Number of subjects analysed
    213
    230
    Units: Percentage of Participants
    number (confidence interval 95%)
        At Month 3 (N=213;230)
    30.5 (24.41 to 37.18)
    92.2 (87.91 to 95.30)
        At Month 10 (N=206;216)
    13.1 (8.82 to 18.49)
    69.0 (62.35 to 75.08)
        At Month 11 (N=211;218)
    97.2 (93.91 to 98.95)
    94.5 (90.58 to 97.12)
    No statistical analyses for this end point

    Secondary: Anti-PRP antibody concentrations

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    End point title
    		 Anti-PRP antibody concentrations
    End point description
    Anti-PRP antibody concentrations were presented as GMCs and expressed in μg/mL, as assessed by ELISA. The analysis was performed on PPS, which included all eligible subjects who received all DTPa-combination study vaccines as per protocol, who had anti-PRP results post-vaccination, who complied with vaccination/blood draw intervals, without intercurrent conditions and without prohibited concomitant medication/vaccination.
    End point type
    Secondary
    End point timeframe
    At Month 3 (i.e., 1-month post-primary vaccination), Month 10 (i.e., pre-booster) and Month 11 (i.e., 1-month post-booster vaccination)
    End point values
    		 Infanrix Hexa Vaxelis
    Number of subjects analysed
    213
    230
    Units: μg/mL
    geometric mean (confidence interval 95%)
        At Month 3 (N=213;230)
    0.5 (0.41 to 0.62)
    11.3 (9.35 to 13.60)
        At Month 10 (N=206;216)
    0.2 (0.19 to 0.28)
    1.9 (1.56 to 2.26)
        At Month 11 (N=211;218)
    12.0 (9.96 to 14.34)
    12.9 (10.75 to 15.55)
    No statistical analyses for this end point

    Secondary: Number of subjects with unsolicited adverse events (AEs)

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    End point title
    		 Number of subjects with unsolicited adverse events (AEs)
    End point description
    AEs are defined as any untoward medical occurrence in a subject or subjects, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The analysis was performed on the ES, which included all vaccinated subjects who were analysed according to the intervention they receive at Dose 1.
    End point type
    Secondary
    End point timeframe
    During the 31-day (Days 1-31) follow-up period after each vaccination (vaccines administered at 2, 4 and 12 months of age)
    End point values
    		 Infanrix Hexa Vaxelis
    Number of subjects analysed
    249
    251
    Units: Participants
    178
    199
    No statistical analyses for this end point

    Secondary: Number of subjects with serious adverse events (SAEs)

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    End point title
    		 Number of subjects with serious adverse events (SAEs)
    End point description
    An SAEs is defined as any untoward medical occurrence that, at any dose, result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect. The analysis was performed on the ES, which included all vaccinated subjects who were analysed according to the intervention they receive at Dose 1.
    End point type
    Secondary
    End point timeframe
    Throughout the entire period of the study (from Day 1 up to study end [Month 11])
    End point values
    		 Infanrix Hexa Vaxelis
    Number of subjects analysed
    249
    251
    Units: Participants
    14
    10
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious Adverse Events (SAEs) were collected throughout the entire period of the study (from Day 1 up to study end [Month 11]). Non Serious AEs (Other AEs) were collected 31 days after each vaccination (vaccines administered ot 2, 4 and 12 months of age).
    Adverse event reporting additional description
    As number of occurrences of SAEs was not collected, number of subjects affected was reported instead.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Infanrix Hexa
    Reporting group description
    		 All subjects in this group received 3 doses (2 primary doses and 1 booster dose) of DTPa-HBV-IPV/Hib vaccine co-administered with 3 doses of pneumococcal 13 valent conjugate vaccine at 2, 4, and 12 months of age.

    Reporting group title
    Vaxelis
    Reporting group description
    		 All subjects in this group received 3 doses (2 primary doses and 1 booster dose) of DTaP5 HBV IPV Hib vaccine co-administered with 3 doses of pneumococcal 13 valent conjugate vaccine at 2, 4, and 12 months of age.

    Serious adverse events
    		 Infanrix Hexa Vaxelis
    Total subjects affected by serious adverse events
         subjects affected / exposed
    14 / 249 (5.62%)
    10 / 251 (3.98%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Investigations
    Enterovirus test positive
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (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
    Hydrocele
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Febrile convulsion
         subjects affected / exposed
    1 / 249 (0.40%)
    1 / 251 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    2 / 249 (0.80%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 249 (0.80%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Testicular torsion
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (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
    Respiratory failure
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (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
    1 / 249 (0.40%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perirectal abscess
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parainfluenzae virus infection
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis norovirus
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 251 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    2 / 249 (0.80%)
    3 / 251 (1.20%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenovirus infection
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess neck
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    2 / 249 (0.80%)
    0 / 251 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    1 / 249 (0.40%)
    3 / 251 (1.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    0 / 249 (0.00%)
    2 / 251 (0.80%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhinovirus infection
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (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
    Hypophagia
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (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
    		 Infanrix Hexa Vaxelis
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    178 / 249 (71.49%)
    199 / 251 (79.28%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Haemangioma of skin
         subjects affected / exposed
    2 / 249 (0.80%)
    1 / 251 (0.40%)
         occurrences all number
    2
    1
    Melanocytic naevus
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 251 (0.40%)
         occurrences all number
    0
    1
    Vascular disorders
    Pallor
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Injection site induration
         subjects affected / exposed
    3 / 249 (1.20%)
    0 / 251 (0.00%)
         occurrences all number
    3
    0
    Administration site haemorrhage
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 251 (0.40%)
         occurrences all number
    0
    1
    Administration site pain
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 251 (0.40%)
         occurrences all number
    0
    1
    Crying
         subjects affected / exposed
    5 / 249 (2.01%)
    7 / 251 (2.79%)
         occurrences all number
    5
    7
    Discomfort
         subjects affected / exposed
    2 / 249 (0.80%)
    4 / 251 (1.59%)
         occurrences all number
    2
    4
    Fatigue
         subjects affected / exposed
    2 / 249 (0.80%)
    3 / 251 (1.20%)
         occurrences all number
    2
    4
    Hyperpyrexia
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 251 (0.40%)
         occurrences all number
    0
    1
    Induration
         subjects affected / exposed
    1 / 249 (0.40%)
    1 / 251 (0.40%)
         occurrences all number
    1
    1
    Inflammation
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 251 (0.40%)
         occurrences all number
    0
    1
    Injection site discomfort
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 251 (0.40%)
         occurrences all number
    0
    1
    Injection site erythema
         subjects affected / exposed
    6 / 249 (2.41%)
    8 / 251 (3.19%)
         occurrences all number
    8
    9
    Injection site haemorrhage
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (0.00%)
         occurrences all number
    1
    0
    Injection site oedema
         subjects affected / exposed
    0 / 249 (0.00%)
    2 / 251 (0.80%)
         occurrences all number
    0
    2
    Injection site swelling
         subjects affected / exposed
    7 / 249 (2.81%)
    8 / 251 (3.19%)
         occurrences all number
    8
    11
    Injection site warmth
         subjects affected / exposed
    0 / 249 (0.00%)
    2 / 251 (0.80%)
         occurrences all number
    0
    2
    Irritability postvaccinal
         subjects affected / exposed
    1 / 249 (0.40%)
    1 / 251 (0.40%)
         occurrences all number
    1
    1
    Malaise
         subjects affected / exposed
    2 / 249 (0.80%)
    3 / 251 (1.20%)
         occurrences all number
    3
    3
    Nodule
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 251 (0.40%)
         occurrences all number
    0
    1
    Pain
         subjects affected / exposed
    1 / 249 (0.40%)
    2 / 251 (0.80%)
         occurrences all number
    1
    3
    Peripheral swelling
         subjects affected / exposed
    4 / 249 (1.61%)
    4 / 251 (1.59%)
         occurrences all number
    4
    4
    Pyrexia
         subjects affected / exposed
    103 / 249 (41.37%)
    132 / 251 (52.59%)
         occurrences all number
    181
    237
    Swelling
         subjects affected / exposed
    1 / 249 (0.40%)
    1 / 251 (0.40%)
         occurrences all number
    1
    1
    Vaccination site erythema
         subjects affected / exposed
    0 / 249 (0.00%)
    2 / 251 (0.80%)
         occurrences all number
    0
    2
    Vaccination site granuloma
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 251 (0.40%)
         occurrences all number
    0
    2
    Vaccination site induration
         subjects affected / exposed
    0 / 249 (0.00%)
    2 / 251 (0.80%)
         occurrences all number
    0
    2
    Vaccination site swelling
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 251 (0.40%)
         occurrences all number
    0
    1
    Injection site pain
         subjects affected / exposed
    6 / 249 (2.41%)
    8 / 251 (3.19%)
         occurrences all number
    7
    8
    Immune system disorders
    Allergy to arthropod bite
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 251 (0.40%)
         occurrences all number
    0
    1
    Food allergy
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 251 (0.40%)
         occurrences all number
    0
    1
    Milk allergy
         subjects affected / exposed
    0 / 249 (0.00%)
    3 / 251 (1.20%)
         occurrences all number
    0
    3
    Reproductive system and breast disorders
    Genital labial adhesions
         subjects affected / exposed
    2 / 249 (0.80%)
    2 / 251 (0.80%)
         occurrences all number
    2
    2
    Respiratory, thoracic and mediastinal disorders
    Bronchial hyperreactivity
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 251 (0.40%)
         occurrences all number
    0
    1
    Bronchospasm
         subjects affected / exposed
    0 / 249 (0.00%)
    2 / 251 (0.80%)
         occurrences all number
    0
    2
    Catarrh
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 251 (0.40%)
         occurrences all number
    0
    1
    Cough
         subjects affected / exposed
    7 / 249 (2.81%)
    5 / 251 (1.99%)
         occurrences all number
    8
    6
    Nasal congestion
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 251 (0.40%)
         occurrences all number
    0
    1
    Pharyngeal inflammation
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (0.00%)
         occurrences all number
    1
    0
    Respiratory disorder
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (0.00%)
         occurrences all number
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 249 (0.00%)
    4 / 251 (1.59%)
         occurrences all number
    0
    4
    Psychiatric disorders
    Restlessness
         subjects affected / exposed
    8 / 249 (3.21%)
    13 / 251 (5.18%)
         occurrences all number
    14
    18
    Agitation
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 251 (0.40%)
         occurrences all number
    0
    1
    Anxiety
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (0.00%)
         occurrences all number
    1
    0
    Depressed mood
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (0.00%)
         occurrences all number
    1
    0
    Insomnia
         subjects affected / exposed
    1 / 249 (0.40%)
    2 / 251 (0.80%)
         occurrences all number
    1
    2
    Irritability
         subjects affected / exposed
    31 / 249 (12.45%)
    37 / 251 (14.74%)
         occurrences all number
    48
    56
    Sleep disorder
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 251 (0.40%)
         occurrences all number
    0
    1
    Investigations
    Blood iron decreased
         subjects affected / exposed
    1 / 249 (0.40%)
    2 / 251 (0.80%)
         occurrences all number
    1
    2
    Body temperature decreased
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 251 (0.40%)
         occurrences all number
    0
    1
    Body temperature increased
         subjects affected / exposed
    3 / 249 (1.20%)
    5 / 251 (1.99%)
         occurrences all number
    3
    5
    Injury, poisoning and procedural complications
    Nasal injury
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (0.00%)
         occurrences all number
    1
    0
    Arthropod bite
         subjects affected / exposed
    1 / 249 (0.40%)
    2 / 251 (0.80%)
         occurrences all number
    1
    2
    Bite
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (0.00%)
         occurrences all number
    1
    0
    Electric shock
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 251 (0.40%)
         occurrences all number
    0
    1
    Eye injury
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 251 (0.40%)
         occurrences all number
    0
    1
    Face injury
         subjects affected / exposed
    2 / 249 (0.80%)
    0 / 251 (0.00%)
         occurrences all number
    2
    0
    Hair-thread tourniquet syndrome
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 251 (0.40%)
         occurrences all number
    0
    1
    Head injury
         subjects affected / exposed
    2 / 249 (0.80%)
    1 / 251 (0.40%)
         occurrences all number
    2
    1
    Tibia fracture
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (0.00%)
         occurrences all number
    1
    0
    Vascular procedure complication
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 251 (0.40%)
         occurrences all number
    0
    1
    Congenital, familial and genetic disorders
    Developmental hip dysplasia
         subjects affected / exposed
    0 / 249 (0.00%)
    2 / 251 (0.80%)
         occurrences all number
    0
    2
    Microcephaly
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 251 (0.40%)
         occurrences all number
    0
    1
    Odontogenic cyst
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 251 (0.40%)
         occurrences all number
    0
    1
    Plagiocephaly
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 251 (0.40%)
         occurrences all number
    0
    1
    Ankyloglossia congenital
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Pulmonary valve stenosis
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 251 (0.40%)
         occurrences all number
    0
    1
    Nervous system disorders
    Head titubation
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 251 (0.40%)
         occurrences all number
    0
    1
    Hypertonia
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (0.00%)
         occurrences all number
    1
    0
    Somnolence
         subjects affected / exposed
    4 / 249 (1.61%)
    5 / 251 (1.99%)
         occurrences all number
    4
    5
    Syncope
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 251 (0.40%)
         occurrences all number
    0
    1
    Lymphadenopathy
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (0.00%)
         occurrences all number
    1
    0
    Thrombocytosis
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (0.00%)
         occurrences all number
    1
    0
    Ear and labyrinth disorders
    Otorrhoea
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 251 (0.40%)
         occurrences all number
    0
    1
    Eye disorders
    Astigmatism
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (0.00%)
         occurrences all number
    1
    0
    Dacryostenosis acquired
         subjects affected / exposed
    3 / 249 (1.20%)
    1 / 251 (0.40%)
         occurrences all number
    3
    1
    Eye haematoma
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 251 (0.40%)
         occurrences all number
    0
    1
    Eye irritation
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 251 (0.40%)
         occurrences all number
    0
    1
    Hypermetropia
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (0.00%)
         occurrences all number
    1
    0
    Corneal erosion
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 251 (0.40%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Frequent bowel movements
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (0.00%)
         occurrences all number
    1
    0
    Abdominal distension
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain
         subjects affected / exposed
    6 / 249 (2.41%)
    4 / 251 (1.59%)
         occurrences all number
    6
    4
    Abdominal pain upper
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (0.00%)
         occurrences all number
    1
    0
    Anal erythema
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (0.00%)
         occurrences all number
    1
    0
    Anal fissure
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 251 (0.40%)
         occurrences all number
    0
    1
    Constipation
         subjects affected / exposed
    3 / 249 (1.20%)
    9 / 251 (3.59%)
         occurrences all number
    3
    10
    Dental cyst
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 251 (0.40%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    15 / 249 (6.02%)
    16 / 251 (6.37%)
         occurrences all number
    20
    19
    Dry mouth
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 251 (0.40%)
         occurrences all number
    0
    1
    Flatulence
         subjects affected / exposed
    2 / 249 (0.80%)
    4 / 251 (1.59%)
         occurrences all number
    2
    4
    Gastrooesophageal reflux disease
         subjects affected / exposed
    6 / 249 (2.41%)
    4 / 251 (1.59%)
         occurrences all number
    6
    4
    Infantile colic
         subjects affected / exposed
    3 / 249 (1.20%)
    2 / 251 (0.80%)
         occurrences all number
    3
    2
    Nausea
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (0.00%)
         occurrences all number
    1
    0
    Odynophagia
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (0.00%)
         occurrences all number
    1
    0
    Oral pain
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (0.00%)
         occurrences all number
    1
    0
    Regurgitation
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 251 (0.40%)
         occurrences all number
    0
    1
    Teething
         subjects affected / exposed
    3 / 249 (1.20%)
    1 / 251 (0.40%)
         occurrences all number
    4
    2
    Vomiting
         subjects affected / exposed
    8 / 249 (3.21%)
    5 / 251 (1.99%)
         occurrences all number
    10
    5
    Haematochezia
         subjects affected / exposed
    2 / 249 (0.80%)
    0 / 251 (0.00%)
         occurrences all number
    2
    0
    Skin and subcutaneous tissue disorders
    Rash pruritic
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (0.00%)
         occurrences all number
    1
    0
    Dermatitis
         subjects affected / exposed
    7 / 249 (2.81%)
    4 / 251 (1.59%)
         occurrences all number
    7
    4
    Dermatitis atopic
         subjects affected / exposed
    3 / 249 (1.20%)
    1 / 251 (0.40%)
         occurrences all number
    3
    1
    Dermatitis diaper
         subjects affected / exposed
    6 / 249 (2.41%)
    6 / 251 (2.39%)
         occurrences all number
    6
    7
    Dry skin
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (0.00%)
         occurrences all number
    1
    0
    Eczema
         subjects affected / exposed
    6 / 249 (2.41%)
    5 / 251 (1.99%)
         occurrences all number
    7
    5
    Erythema
         subjects affected / exposed
    2 / 249 (0.80%)
    3 / 251 (1.20%)
         occurrences all number
    2
    3
    Papule
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (0.00%)
         occurrences all number
    1
    0
    Rash
         subjects affected / exposed
    5 / 249 (2.01%)
    3 / 251 (1.20%)
         occurrences all number
    5
    3
    Rash macular
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (0.00%)
         occurrences all number
    1
    0
    Seborrhoeic dermatitis
         subjects affected / exposed
    1 / 249 (0.40%)
    1 / 251 (0.40%)
         occurrences all number
    1
    1
    Urticaria
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 251 (0.40%)
         occurrences all number
    0
    1
    Skin mass
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Chromaturia
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    0 / 249 (0.00%)
    2 / 251 (0.80%)
         occurrences all number
    0
    2
    Torticollis
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    6 / 249 (2.41%)
    5 / 251 (1.99%)
         occurrences all number
    7
    5
    Acarodermatitis
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (0.00%)
         occurrences all number
    1
    0
    Asymptomatic COVID-19
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (0.00%)
         occurrences all number
    1
    0
    Bronchiolitis
         subjects affected / exposed
    4 / 249 (1.61%)
    3 / 251 (1.20%)
         occurrences all number
    4
    3
    Candida nappy rash
         subjects affected / exposed
    2 / 249 (0.80%)
    2 / 251 (0.80%)
         occurrences all number
    2
    2
    Conjunctivitis
         subjects affected / exposed
    14 / 249 (5.62%)
    14 / 251 (5.58%)
         occurrences all number
    14
    15
    COVID-19
         subjects affected / exposed
    14 / 249 (5.62%)
    9 / 251 (3.59%)
         occurrences all number
    14
    9
    Croup infectious
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 251 (0.40%)
         occurrences all number
    0
    1
    Ear infection
         subjects affected / exposed
    2 / 249 (0.80%)
    1 / 251 (0.40%)
         occurrences all number
    2
    1
    Escherichia urinary tract infection
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 251 (0.40%)
         occurrences all number
    0
    1
    Exanthema subitum
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 251 (0.40%)
         occurrences all number
    0
    1
    Fungal skin infection
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (0.00%)
         occurrences all number
    1
    0
    Gastroenteritis
         subjects affected / exposed
    9 / 249 (3.61%)
    10 / 251 (3.98%)
         occurrences all number
    9
    11
    Hand-foot-and-mouth disease
         subjects affected / exposed
    2 / 249 (0.80%)
    2 / 251 (0.80%)
         occurrences all number
    2
    2
    Herpangina
         subjects affected / exposed
    1 / 249 (0.40%)
    2 / 251 (0.80%)
         occurrences all number
    1
    2
    Impetigo
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 251 (0.40%)
         occurrences all number
    0
    1
    Infected fistula
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 251 (0.40%)
         occurrences all number
    0
    1
    Influenza
         subjects affected / exposed
    2 / 249 (0.80%)
    0 / 251 (0.00%)
         occurrences all number
    2
    0
    Laryngitis
         subjects affected / exposed
    5 / 249 (2.01%)
    4 / 251 (1.59%)
         occurrences all number
    5
    4
    Nasopharyngitis
         subjects affected / exposed
    6 / 249 (2.41%)
    14 / 251 (5.58%)
         occurrences all number
    7
    14
    Oral candidiasis
         subjects affected / exposed
    4 / 249 (1.61%)
    5 / 251 (1.99%)
         occurrences all number
    4
    5
    Otitis media
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (0.00%)
         occurrences all number
    1
    0
    Otitis media acute
         subjects affected / exposed
    5 / 249 (2.01%)
    6 / 251 (2.39%)
         occurrences all number
    5
    6
    Paronychia
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 251 (0.40%)
         occurrences all number
    0
    1
    Pharyngitis
         subjects affected / exposed
    1 / 249 (0.40%)
    3 / 251 (1.20%)
         occurrences all number
    1
    3
    Pharyngotonsillitis
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (0.00%)
         occurrences all number
    1
    0
    Pilonidal disease
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (0.00%)
         occurrences all number
    1
    0
    Pneumonia
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 251 (0.40%)
         occurrences all number
    0
    1
    Pyelonephritis
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (0.00%)
         occurrences all number
    1
    0
    Respiratory tract infection
         subjects affected / exposed
    2 / 249 (0.80%)
    6 / 251 (2.39%)
         occurrences all number
    2
    8
    Respiratory tract infection viral
         subjects affected / exposed
    3 / 249 (1.20%)
    3 / 251 (1.20%)
         occurrences all number
    3
    3
    Rhinitis
         subjects affected / exposed
    2 / 249 (0.80%)
    5 / 251 (1.99%)
         occurrences all number
    2
    5
    Roseola
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (0.00%)
         occurrences all number
    1
    0
    Subglottic laryngitis
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 251 (0.40%)
         occurrences all number
    0
    1
    Suspected COVID-19
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 251 (0.40%)
         occurrences all number
    0
    1
    Tonsillitis
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 251 (0.40%)
         occurrences all number
    0
    1
    Tonsillitis bacterial
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 251 (0.40%)
         occurrences all number
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    18 / 249 (7.23%)
    20 / 251 (7.97%)
         occurrences all number
    22
    24
    Urinary tract infection
         subjects affected / exposed
    1 / 249 (0.40%)
    3 / 251 (1.20%)
         occurrences all number
    1
    3
    Viral infection
         subjects affected / exposed
    1 / 249 (0.40%)
    4 / 251 (1.59%)
         occurrences all number
    1
    4
    Viral rash
         subjects affected / exposed
    1 / 249 (0.40%)
    2 / 251 (0.80%)
         occurrences all number
    1
    2
    Viral upper respiratory tract infection
         subjects affected / exposed
    5 / 249 (2.01%)
    6 / 251 (2.39%)
         occurrences all number
    6
    6
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 251 (0.40%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    4 / 249 (1.61%)
    5 / 251 (1.99%)
         occurrences all number
    5
    5
    Hypoferritinaemia
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (0.00%)
         occurrences all number
    1
    0
    Iron deficiency
         subjects affected / exposed
    0 / 249 (0.00%)
    1 / 251 (0.40%)
         occurrences all number
    0
    1
    Lactose intolerance
         subjects affected / exposed
    1 / 249 (0.40%)
    0 / 251 (0.00%)
         occurrences all number
    1
    0

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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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