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    Clinical Trial Results:
    Post-Authorization Safety, Tolerability and Immunogenicity Evaluation of HyQvia in Pediatric Subjects With Primary Immunodeficiency Diseases

    Summary
    EudraCT number
    		 2016-003438-26
    Trial protocol
    		 GB   SE   DK   CZ   SK   FR   GR   HU  
    Global end of trial date
    15 Jan 2021

    Results information
    Results version number
    		 v1
    This version publication date
    04 Aug 2021
    First version publication date
    04 Aug 2021
    Other versions
    		 v2

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    161504
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03116347
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Baxalta Innovations GmbH
    Sponsor organisation address
    Industriestrasse 67, Vienna, Austria, 1220
    Public contact
    Study Director, Baxalta Innovations GmbH, ClinicalTransparency@takeda.com
    Scientific contact
    Study Director, Baxalta Innovations GmbH, ClinicalTransparency@takeda.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?
    No
    Results analysis stage
    Analysis stage
    Interim
    Date of interim/final analysis
    14 May 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jan 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to evaluate the safety of HyQvia treatment in pediatric subjects with Primary Immunodeficiency Diseases (PIDD) who received immunoglobulin therapy prior to study enrollment.
    Protection of trial subjects
    This study will be conducted in accordance with this protocol, the International Council for Harmonisation Guideline for Good Clinical Practice E6 (ICH GCP, R2, November 2016), Title 21 of the US Code of Federal Regulations , the EU Directives 2001/20/EC and 2005/28/EC, the Declaration of Helsinki and applicable national and local regulatory requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Jun 2017
    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
    Czechia: 7
    Country: Number of subjects enrolled
    Denmark: 3
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Greece: 6
    Country: Number of subjects enrolled
    Slovakia: 9
    Country: Number of subjects enrolled
    Sweden: 4
    Country: Number of subjects enrolled
    United Kingdom: 9
    Country: Number of subjects enrolled
    Hungary: 3
    Worldwide total number of subjects
    42
    EEA total number of subjects
    33
    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)
    0
    Children (2-11 years)
    21
    Adolescents (12-17 years)
    21
    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
    		 The study was conducted at 16 sites in Czech Republic, Denmark, France, Greece, Slovakia, Sweden, Hungary, and United Kingdom.

    Pre-assignment
    Screening details
    		 A total of 42 subjects were enrolled and treated in this study. Based on one year safety follow-up, subjects will be followed to Epoch 3 if anti-rHuPH20 antibody titer >= 160, and who experience either a related SAE or a related severe AE during Epoch 1 or Epoch 2. Data was reported based on interim analysis cut-off date (14-May-2020).

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Epoch 1
    Arm description
    		 Pediatric subjects with PIDD who were on non-HyQvia intravenous (IV) or subcutaneous (SC) treatment with immunoglobulin (IV-pretreated, SC-pretreated) were enrolled and treated with HyQvia (Immune Globulin Infusion 10% [Human] with Recombinant Human Hyaluronidase) SC with a dose or interval ramp-up period of up to 6 weeks. HyQvia was administered at a starting dose of 5 milliliter per hour per site (mL/h/site) to maximum tolerated dose of 80 mL/h/site (for subject with body weight [BW] < 40 kilogram [kg]) or starting dose of 10 mL/h/site to maximum tolerated dose of 240 mL/h/site (for subject with BW greater than or equal to [>=] 40 kg).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Immune Globulin Infusion
    Investigational medicinal product code
    Other name
    HyQvia
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Pediatric subjects treated with HyQvia subcutaneously with a dose or interval ramp-up period of up to 6 weeks.

    Arm title
    		 Epoch 2
    Arm description
    		 Pediatric subjects who were treated with HyQvia prior to this study and those who completed the ramp-up period (Epoch 1) are followed by Epoch 2 with HyQvia treatment. After one year in Epoch 2, subjects with anti-rHuPH20 antibody titer <160 at all time-points during the study will complete the study termination/completion visit at the next possible occasion. Subjects with anti-rHuPH20 antibody titer >= 160 during the study and/or at the last measurement will continue for an additional two years of HyQvia treatment and observation. HyQvia was administered at a starting dose of 10 mL/h/site to maximum tolerated dose of 160 mL/h/site (for subject with body weight [BW] <40kg) or starting dose of 10 mL/h/site to maximum tolerated dose of 300 mL/h/site (for subject with BW >=40kg).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Immune Globulin Infusion
    Investigational medicinal product code
    Other name
    HyQvia
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects who were treated with HyQvia prior to this study, and those who completed the ramp up period (Epoch 1) is followed by Epoch 2 with HyQvia treatment.

    Number of subjects in period 1
    		Epoch 1 Epoch 2
    Started
    23
    19
    Completed
    11
    11
    Not completed
    12
    8
         Consent withdrawn by subject
    1
    1
         Ongoing
    11
    6
         Lost to follow-up
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Epoch 1
    Reporting group description
    		 Pediatric subjects with PIDD who were on non-HyQvia intravenous (IV) or subcutaneous (SC) treatment with immunoglobulin (IV-pretreated, SC-pretreated) were enrolled and treated with HyQvia (Immune Globulin Infusion 10% [Human] with Recombinant Human Hyaluronidase) SC with a dose or interval ramp-up period of up to 6 weeks. HyQvia was administered at a starting dose of 5 milliliter per hour per site (mL/h/site) to maximum tolerated dose of 80 mL/h/site (for subject with body weight [BW] < 40 kilogram [kg]) or starting dose of 10 mL/h/site to maximum tolerated dose of 240 mL/h/site (for subject with BW greater than or equal to [>=] 40 kg).

    Reporting group title
    Epoch 2
    Reporting group description
    		 Pediatric subjects who were treated with HyQvia prior to this study and those who completed the ramp-up period (Epoch 1) are followed by Epoch 2 with HyQvia treatment. After one year in Epoch 2, subjects with anti-rHuPH20 antibody titer <160 at all time-points during the study will complete the study termination/completion visit at the next possible occasion. Subjects with anti-rHuPH20 antibody titer >= 160 during the study and/or at the last measurement will continue for an additional two years of HyQvia treatment and observation. HyQvia was administered at a starting dose of 10 mL/h/site to maximum tolerated dose of 160 mL/h/site (for subject with body weight [BW] <40kg) or starting dose of 10 mL/h/site to maximum tolerated dose of 300 mL/h/site (for subject with BW >=40kg).

    Reporting group values
    		 Epoch 1 Epoch 2 Total
    Number of subjects
    		 23 19 42
    Age Categorical
    Units:
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 10.3 ± 3.82 11.7 ± 4.33 -
    Gender Categorical
    Units: Subjects
        Female
    		 5 3 8
        Male
    		 18 16 34
    Race
    Units: Subjects
        American Indian Or Alaska Native
    		 0 0 0
        Asian
    		 0 0 0
        Black Or African American
    		 0 0 0
        Native Hawaiian Or Other Pacific Islander
    		 0 0 0
        White
    		 22 19 41
        Unknown/Not Available/Not Reported
    		 0 0 0
        Not Collected Per Local Regulations
    		 1 0 1
        Other
    		 0 0 0
    Ethnicity
    Units: Subjects
        Hispanic Or Latino
    		 0 0 0
        Not Hispanic Or Latino
    		 23 19 42
        Not Reported
    		 0 0 0
        Unknown
    		 0 0 0
        Decline To Provide
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Epoch 1
    Reporting group description
    		 Pediatric subjects with PIDD who were on non-HyQvia intravenous (IV) or subcutaneous (SC) treatment with immunoglobulin (IV-pretreated, SC-pretreated) were enrolled and treated with HyQvia (Immune Globulin Infusion 10% [Human] with Recombinant Human Hyaluronidase) SC with a dose or interval ramp-up period of up to 6 weeks. HyQvia was administered at a starting dose of 5 milliliter per hour per site (mL/h/site) to maximum tolerated dose of 80 mL/h/site (for subject with body weight [BW] < 40 kilogram [kg]) or starting dose of 10 mL/h/site to maximum tolerated dose of 240 mL/h/site (for subject with BW greater than or equal to [>=] 40 kg).

    Reporting group title
    Epoch 2
    Reporting group description
    		 Pediatric subjects who were treated with HyQvia prior to this study and those who completed the ramp-up period (Epoch 1) are followed by Epoch 2 with HyQvia treatment. After one year in Epoch 2, subjects with anti-rHuPH20 antibody titer <160 at all time-points during the study will complete the study termination/completion visit at the next possible occasion. Subjects with anti-rHuPH20 antibody titer >= 160 during the study and/or at the last measurement will continue for an additional two years of HyQvia treatment and observation. HyQvia was administered at a starting dose of 10 mL/h/site to maximum tolerated dose of 160 mL/h/site (for subject with body weight [BW] <40kg) or starting dose of 10 mL/h/site to maximum tolerated dose of 300 mL/h/site (for subject with BW >=40kg).

    Primary: Number of Subjects with All Severe Related Treatment-emergent Adverse Events (TEAEs) per Infusion (Excluding Infections)

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    End point title
    		 Number of Subjects with All Severe Related Treatment-emergent Adverse Events (TEAEs) per Infusion (Excluding Infections) [1]
    End point description
    An Adverse Events (AEs) was defined as any untoward medical occurrence in a subject administered an investigational product (IP) that does not necessarily have a causal relationship with the treatment. TEAE was defined as AEs with onset after date-time of first dose of IP, or medical conditions present prior to the start of IP but increased in severity or relationship after date-time of first dose of IP. Related AEs was defined as an AE that was recorded as “possibly related” or “probably related” to IP was considered “related AE”, and AE recorded as “unlikely related” or “not related” was considered “unrelated” AE. Safety analysis set included all subjects in the full analysis set (enrolled set) who received at least one dose of HyQvia.
    End point type
    Primary
    End point timeframe
    From start of study drug administration up to 35 months (Data cut-off date: 14-May-2020)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical and comparison analyses were performed for this endpoint.
    End point values
    		 Epoch 1 Epoch 2
    Number of subjects analysed
    23
    19
    Units: Subjects
    1
    0
    No statistical analyses for this end point

    Primary: Rate of All Severe Related TEAEs per Infusion (Excluding Infections)

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    End point title
    		 Rate of All Severe Related TEAEs per Infusion (Excluding Infections) [2]
    End point description
    An Adverse Events (AEs) was defined as any untoward medical occurrence in a subject administered an investigational product (IP) that does not necessarily have a causal relationship with the treatment. TEAE was defined as AEs with onset after date-time of first dose of IP in Epoch 1, or medical conditions present prior to the start of IP but increased in severity or relationship after date-time of first dose of IP in Epoch 1. Severe Related adverse events rate per infusion= number of adverse events/total number of infusions prior to subject's start date of non-response. Severe related TEAEs per Infusion was calculated based on events per 1000 subject years, Safety analysis set included all subjects in the full analysis set (enrolled set) who received at least one dose of HyQvia.
    End point type
    Primary
    End point timeframe
    From start of study drug administration up to 35 months (Data cut-off date: 14-May-2020)
    Notes
    [2] - 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: No statistical and comparison analyses were performed for this endpoint.
    End point values
    		 Epoch 1 Epoch 2
    Number of subjects analysed
    23
    19
    Units: Events per infusion
        number (not applicable)
    0.1
    0
    No statistical analyses for this end point

    Primary: Number of Subjects with Related Serious TEAEs per Infusion (Excluding Infections)

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    End point title
    		 Number of Subjects with Related Serious TEAEs per Infusion (Excluding Infections) [3]
    End point description
    TEAE was defined as AEs with onset after date-time of first dose of IP in Epoch 1, or medical conditions present prior to the start of IP but increased in severity or relationship after date-time of first dose of IP in Epoch 1. A serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged in-patient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Related TEAE = AEs recorded in the study database as “possibly related” or “probably related” to IP. Safety analysis set included all subjects in the full analysis set (enrolled set) who received at least one dose of HyQvia.
    End point type
    Primary
    End point timeframe
    From start of study drug administration up to 35 months (Data cut-off date: 14-May-2020)
    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: No statistical and comparison analyses were performed for this endpoint.
    End point values
    		 Epoch 1 Epoch 2
    Number of subjects analysed
    23
    19
    Units: Subjects
    0
    0
    No statistical analyses for this end point

    Primary: Rate of Related Serious TEAEs per Infusion (Excluding Infections)

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    End point title
    		 Rate of Related Serious TEAEs per Infusion (Excluding Infections) [4]
    End point description
    TEAE was defined as AEs with onset after date-time of first dose of IP in Epoch 1, or medical conditions present prior to the start of IP but increased in severity or relationship after date-time of first dose of IP in Epoch 1. A serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged in-patient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Related TEAE = AEs recorded in the study database as “possibly related” or “probably related” to IP. Related serious adverse events rate per infusion= number of adverse events/total number of infusions prior to subject's start date of non-response. Related serious TEAEs per Infusion was calculated based on events per infusion. Safety analysis set included all subjects in the full analysis set (enrolled set) who received at least one dose of HyQvia.
    End point type
    Primary
    End point timeframe
    From start of study drug administration up to 35 months (Data cut-off date: 14-May-2020)
    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: No statistical and comparison analyses were performed for this endpoint.
    End point values
    		 Epoch 1 Epoch 2
    Number of subjects analysed
    23
    19
    Units: Events per infusion
        number (not applicable)
    0
    0
    No statistical analyses for this end point

    Secondary: Total Serum Trough Levels of Immunoglobulin G (IgG)

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    End point title
    		 Total Serum Trough Levels of Immunoglobulin G (IgG)
    End point description
    Total serum trough levels of IgG in Epoch 1 and 2 were reported. Full analysis set included all participants who provide informed consent and meet enrollment eligibility.
    End point type
    Secondary
    End point timeframe
    Months 6 and 12
    End point values
    		 Epoch 1 Epoch 2
    Number of subjects analysed
    0 [5]
    0 [6]
    Units: Milligram per deciliter (mg/dL)
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [5] - Data will be reported from the final analysis.
    [6] - Data will be reported from the final analysis.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects who Achieved a Treatment Interval of Three or Four weeks in Epoch 2

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    End point title
    		 Percentage of Subjects who Achieved a Treatment Interval of Three or Four weeks in Epoch 2
    End point description
    Percentage of subjects who achieve a treatment interval of three or four weeks in Epoch 2 will be reported.
    End point type
    Secondary
    End point timeframe
    up to Month 12
    End point values
    		 Epoch 1 Epoch 2
    Number of subjects analysed
    0 [7]
    0 [8]
    Units: Percentage of subjects
        number (not applicable)
    Notes
    [7] - Data will be reported from the final analysis.
    [8] - Data will be reported from the final analysis.
    No statistical analyses for this end point

    Secondary: Percentage of Subjects who Maintained a Treatment Interval of Three or Four Weeks in Epoch 2

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    End point title
    		 Percentage of Subjects who Maintained a Treatment Interval of Three or Four Weeks in Epoch 2
    End point description
    Percentage of subjects who maintained a treatment interval of three or four weeks in Epoch 2 will be reported.
    End point type
    Secondary
    End point timeframe
    up to Month 12
    End point values
    		 Epoch 1 Epoch 2
    Number of subjects analysed
    0 [9]
    0 [10]
    Units: Percentage of subjects
        number (not applicable)
    Notes
    [9] - Data will be reported from the final analysis.
    [10] - Data will be reported from the final analysis.
    No statistical analyses for this end point

    Secondary: Number of Subjects with Local TEAEs

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    End point title
    		 Number of Subjects with Local TEAEs
    End point description
    TEAE was defined as AEs with onset after date-time of first dose of IP, or medical conditions present prior to the start of IP but increased in severity or relationship after date-time of first dose of IP. Safety analysis set included all subjects in the full analysis set (enrolled set) who received at least one dose of HyQvia.
    End point type
    Secondary
    End point timeframe
    From start of study drug administration up to 35 months (Data cut-off date: 14-May-2020)
    End point values
    		 Epoch 1 Epoch 2
    Number of subjects analysed
    23
    19
    Units: Subjects
    9
    2
    No statistical analyses for this end point

    Secondary: Rate of Local TEAEs Per Infusion

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    End point title
    		 Rate of Local TEAEs Per Infusion
    End point description
    Local adverse event rate per infusion = number of local adverse events/total number of infusions prior to subject's start date of non-response. Local Adverse Events: comprises all events reported within the MedDRA high level terms "administration site reactions NEC (Not Elsewhere Classified)", "infusion site reactions", and "injection site reactions". Only events are included which start prior to subject's start date of non-response. Safety analysis set included all subjects in the full analysis set (enrolled set) who received at least one dose of HyQvia.
    End point type
    Secondary
    End point timeframe
    From start of study drug administration up to 35 months (Data cut-off date: 14-May-2020)
    End point values
    		 Epoch 1 Epoch 2
    Number of subjects analysed
    23
    19
    Units: Events per infusion
        number (not applicable)
    0.1
    0.1
    No statistical analyses for this end point

    Secondary: Number of Subjects with Local Adverse Reactions

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    End point title
    		 Number of Subjects with Local Adverse Reactions
    End point description
    Local Adverse reactions was defined as any TEAE that meets any of the following criteria: 1) A TEAE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or; 2) A TEAE that begins during infusion of IP or within 72 hours following the end of IP infusion, or; 3) A TEAE for which causality assessment is missing or indeterminate. Safety analysis set included all subjects in the full analysis set (enrolled set) who received at least one dose of HyQvia.
    End point type
    Secondary
    End point timeframe
    From start of study drug administration up to 35 months (Data cut-off date: 14-May-2020)
    End point values
    		 Epoch 1 Epoch 2
    Number of subjects analysed
    23
    19
    Units: Subjects
    9
    2
    No statistical analyses for this end point

    Secondary: Rate of Local Adverse Reaction per Infusion

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    End point title
    		 Rate of Local Adverse Reaction per Infusion
    End point description
    Local adverse reaction per infusion = number of local adverse events/total number of infusions prior to subject's start date of non-response. Safety analysis set included all subjects in the full analysis set (enrolled Set) who received at least one dose of HyQvia.
    End point type
    Secondary
    End point timeframe
    From start of study drug administration up to 35 months (Data cut-off date: 14-May-2020)
    End point values
    		 Epoch 1 Epoch 2
    Number of subjects analysed
    23
    19
    Units: Events per infusion
        number (not applicable)
    0.1
    0.1
    No statistical analyses for this end point

    Secondary: Number of Subjects with Systemic TEAEs

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    End point title
    		 Number of Subjects with Systemic TEAEs
    End point description
    TEAE was defined as AEs with onset after date-time of first dose of IP in Epoch 1, or medical conditions present prior to the start of IP but increased in severity or relationship after date-time of first dose of IP in Epoch 1. Safety analysis set included all subjects in the full analysis set (enrolled set) who received at least one dose of HyQvia.
    End point type
    Secondary
    End point timeframe
    From start of study drug administration up to 35 months (Data cut-off date: 14-May-2020)
    End point values
    		 Epoch 1 Epoch 2
    Number of subjects analysed
    23
    19
    Units: Subjects
    13
    11
    No statistical analyses for this end point

    Secondary: Rate of Systemic TEAEs Per Infusion

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    End point title
    		 Rate of Systemic TEAEs Per Infusion
    End point description
    Systemic TEAEs per infusion = number of local adverse events/total number of infusions prior to subject's start date of non-response. Safety analysis set included all subjects in the full analysis set (enrolled set) who received at least one dose of HyQvia.
    End point type
    Secondary
    End point timeframe
    From start of study drug administration up to 35 months (Data cut-off date: 14-May-2020)
    End point values
    		 Epoch 1 Epoch 2
    Number of subjects analysed
    23
    19
    Units: Events per infusion
        number (not applicable)
    0.2
    0.2
    No statistical analyses for this end point

    Secondary: Number of Subjects with Systemic Adverse Reactions

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    End point title
    		 Number of Subjects with Systemic Adverse Reactions
    End point description
    Number of subjects with systemic adverse reactions were reported. Safety analysis set included all subjects in the full analysis set (enrolled set) who received at least one dose of HyQvia.
    End point type
    Secondary
    End point timeframe
    From start of study drug administration up to 35 months (Data cut-off date: 14-May-2020)
    End point values
    		 Epoch 1 Epoch 2
    Number of subjects analysed
    23
    19
    Units: Subjects
    6
    3
    No statistical analyses for this end point

    Secondary: Rate of Systemic Adverse Reactions Per Infusion

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    End point title
    		 Rate of Systemic Adverse Reactions Per Infusion
    End point description
    Systemic adverse reactions rate per infusion = number of local adverse events/total number of infusions prior to subject's start date of non-response. Safety analysis set included all subjects in the full analysis set (enrolled set) who received at least one dose of HyQvia.
    End point type
    Secondary
    End point timeframe
    From start of study drug administration up to 35 months (Data cut-off date: 14-May-2020)
    End point values
    		 Epoch 1 Epoch 2
    Number of subjects analysed
    23
    19
    Units: Events per infusion
        number (not applicable)
    0.1
    0.1
    No statistical analyses for this end point

    Secondary: Number of Subjects with All TEAEs

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    End point title
    		 Number of Subjects with All TEAEs
    End point description
    TEAE was defined as AEs with onset after date-time of first dose of IP in Epoch 1, or medical conditions present prior to the start of IP but increased in severity or relationship after date-time of first dose of IP in Epoch 1. Safety analysis set included all subjects in the full analysis set (Enrolled set) who received at least one dose of HyQvia.
    End point type
    Secondary
    End point timeframe
    From start of study drug administration up to 35 months (Data cut-off date: 14-May-2020)
    End point values
    		 Epoch 1 Epoch 2
    Number of subjects analysed
    23
    19
    Units: Subjects
    16
    11
    No statistical analyses for this end point

    Secondary: Rate of TEAEs per Infusion

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    End point title
    		 Rate of TEAEs per Infusion
    End point description
    Rate of TEAEs per infusion = number of adverse events/total number of infusions prior to subject's start date of non-response. Safety analysis set included all subjects in the full analysis set (enrolled set) who received at least one dose of HyQvia.
    End point type
    Secondary
    End point timeframe
    From start of study drug administration up to 35 months (Data cut-off date: 14-May-2020)
    End point values
    		 Epoch 1 Epoch 2
    Number of subjects analysed
    23
    19
    Units: Events per infusion
        number (not applicable)
    0.3
    0.2
    No statistical analyses for this end point

    Secondary: Number of Subjects with All Adverse Reactions

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    End point title
    		 Number of Subjects with All Adverse Reactions
    End point description
    Adverse reactions was defined as any TEAE that meets any of the following criteria: 1) A TEAE considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration, or; 2) A TEAE that begins during infusion of IP or within 72 hours following the end of IP infusion, or; 3) A TEAE for which causality assessment is missing or indeterminate. Safety analysis set included all subjects in the full analysis set (enrolled set) who received at least one dose of HyQvia.
    End point type
    Secondary
    End point timeframe
    From start of study drug administration up to 35 months (Data cut-off date: 14-May-2020)
    End point values
    		 Epoch 1 Epoch 2
    Number of subjects analysed
    23
    19
    Units: Subjects
    12
    4
    No statistical analyses for this end point

    Secondary: Rate of Adverse Reaction per Infusion

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    End point title
    		 Rate of Adverse Reaction per Infusion
    End point description
    Rate of adverse reaction per infusion = number of adverse events/total number of infusions prior to subject's start date of non-response. Safety analysis set included all subjects in the full analysis set (enrolled set) who received at least one dose of HyQvia.
    End point type
    Secondary
    End point timeframe
    From start of study drug administration up to 35 months (Data cut-off date: 14-May-2020)
    End point values
    		 Epoch 1 Epoch 2
    Number of subjects analysed
    23
    19
    Units: Events per infusion
        number (not applicable)
    0.1
    0.1
    No statistical analyses for this end point

    Secondary: Number of Subjects with all Temporally Associated TEAEs per infusion (Excluding Infections)

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    End point title
    		 Number of Subjects with all Temporally Associated TEAEs per infusion (Excluding Infections)
    End point description
    Temporally associated TEAEs were all AEs which occur during the infusion or within 72 hours of completion of infusion.
    End point type
    Secondary
    End point timeframe
    From start of study drug administration up to 35 months (Data cut-off date: 14-May-2020)
    End point values
    		 Epoch 1 Epoch 2
    Number of subjects analysed
    0 [11]
    0 [12]
    Units: Subjects
    Notes
    [11] - Data will be reported from the final analysis.
    [12] - Data will be reported from the final analysis.
    No statistical analyses for this end point

    Secondary: Rate of all Temporally Associated TEAEs per Infusion (Excluding Infections)

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    End point title
    		 Rate of all Temporally Associated TEAEs per Infusion (Excluding Infections)
    End point description
    Rate of Temporally associated TEAEs per infusion = number of adverse events/total number of infusions prior to subject's start date of non-response. Safety analysis set included all subjects in the full analysis set (enrolled set) who received at least one dose of HyQvia.
    End point type
    Secondary
    End point timeframe
    From start of study drug administration up to 35 months (Data cut-off date: 14-May-2020)
    End point values
    		 Epoch 1 Epoch 2
    Number of subjects analysed
    0 [13]
    0 [14]
    Units: Events per infusion
        number (not applicable)
    Notes
    [13] - Data will be reported from the final analysis.
    [14] - Data will be reported from the final analysis.
    No statistical analyses for this end point

    Secondary: Number of Subjects with all Causally Related TEAEs per Infusion (Excluding Infections)

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    End point title
    		 Number of Subjects with all Causally Related TEAEs per Infusion (Excluding Infections)
    End point description
    Related TEAEs were defined as causally related TEAEs. Number of Subjects with all causally related TEAEs per infusion (excluding infections) were reported. Safety analysis set included all subjects in the full analysis set (enrolled set) who received at least one dose of HyQvia.
    End point type
    Secondary
    End point timeframe
    From start of study drug administration up to 35 months (Data cut-off date: 14-May-2020)
    End point values
    		 Epoch 1 Epoch 2
    Number of subjects analysed
    23
    19
    Units: Subjects
    10
    2
    No statistical analyses for this end point

    Secondary: Rate of Causally Related TEAEs per Infusion (Excluding Infections)

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    End point title
    		 Rate of Causally Related TEAEs per Infusion (Excluding Infections)
    End point description
    Rate of causally related TEAEs per infusion = number of causally related adverse events/total number of infusions prior to subject's start date of non-response. Safety analysis set included all subjects in the full analysis set (enrolled set) who received at least one dose of HyQvia.
    End point type
    Secondary
    End point timeframe
    From start of study drug administration up to 35 months (Data cut-off date: 14-May-2020)
    End point values
    		 Epoch 1 Epoch 2
    Number of subjects analysed
    23
    19
    Units: Events per infusion
        number (not applicable)
    0.1
    0.1
    No statistical analyses for this end point

    Secondary: Number of Subjects with all Serious TEAEs

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    End point title
    		 Number of Subjects with all Serious TEAEs
    End point description
    Serious TEAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged in-patient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. Safety analysis set included all subjects in the full analysis set (enrolled set) who received at least one dose of HyQvia.
    End point type
    Secondary
    End point timeframe
    From start of study drug administration up to 35 months (Data cut-off date: 14-May-2020)
    End point values
    		 Epoch 1 Epoch 2
    Number of subjects analysed
    23
    19
    Units: Subjects
    1
    3
    No statistical analyses for this end point

    Secondary: Rate of Serious TEAEs per Infusion

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    End point title
    		 Rate of Serious TEAEs per Infusion
    End point description
    Rate of Serious TEAEs per infusion = number of local adverse events/total number of infusions prior to subject's start date of non-response. Safety analysis set included all subjects in the full analysis set (enrolled set) who received at least one dose of HyQvia.
    End point type
    Secondary
    End point timeframe
    From start of study drug administration up to 35 months (Data cut-off date: 14-May-2020)
    End point values
    		 Epoch 1 Epoch 2
    Number of subjects analysed
    23
    19
    Units: Events per infusion
        number (not applicable)
    0.1
    0.1
    No statistical analyses for this end point

    Secondary: Number of Subjects who Developed Positive Titer (>=160) of Binding or Neutralizing Antibodies to rHuPH20

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    End point title
    		 Number of Subjects who Developed Positive Titer (>=160) of Binding or Neutralizing Antibodies to rHuPH20
    End point description
    Number of Subjects who developed positive titer (>=160) of binding or neutralizing antibodies to rHuPH20 were reported. Safety analysis set included all subjects in the full analysis set (enrolled set) who received at least one dose of HyQvia.
    End point type
    Secondary
    End point timeframe
    Epoch 1 (up to 6 weeks) and Epoch 2 (up to 35 months)
    End point values
    		 Epoch 1 Epoch 2
    Number of subjects analysed
    23
    19
    Units: Subjects
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Infusions per Month per Subject

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    End point title
    		 Number of Infusions per Month per Subject
    End point description
    Number of infusions per month was calculated as total number of infusions per duration of treatment (days) * 30.4 days per month. Number of infusions per month per subject was reported. Safety analysis set included all subjects in the full analysis set (enrolled set) who received at least one dose of HyQvia.
    End point type
    Secondary
    End point timeframe
    Epoch 1 (up to 6 weeks) and Epoch 2 (up to 35 months)
    End point values
    		 Epoch 1 Epoch 2
    Number of subjects analysed
    23
    19
    Units: Infusions per month
        arithmetic mean (standard deviation)
    1.62 ± 1.423
    1.11 ± 0.517
    No statistical analyses for this end point

    Secondary: Number of Infusion Sites per Infusion per Month per Subject

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    End point title
    		 Number of Infusion Sites per Infusion per Month per Subject
    End point description
    Number of infusion sites per infusion per month was calculated as total number of infusion sites per total number of infusions per duration of treatment (days) * 30.4 days per month. Mean number of infusion sites per infusion per month per subject was reported. Safety analysis set included all subjects in the full analysis set (enrolled set) who received at least one dose of HyQvia.
    End point type
    Secondary
    End point timeframe
    Epoch 1 (up to 6 weeks) and Epoch 2 (up to 35 months)
    End point values
    		 Epoch 1 Epoch 2
    Number of subjects analysed
    23
    19
    Units: Infusion sites per infusion/Month
        arithmetic mean (standard deviation)
    0.43 ± 0.824
    0.31 ± 0.622
    No statistical analyses for this end point

    Secondary: Duration of Infusion

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    End point title
    		 Duration of Infusion
    End point description
    Duration of infusion was defined as time from the start of rHuPH20 infusion until the stop time of immunoglobulin infusion. Duration of infusion was calculated as stop time of infusion – start time of infusion. Safety analysis set included all subjects in the full analysis set (enrolled set) who received at least one dose of HyQvia.
    End point type
    Secondary
    End point timeframe
    Epoch 1 (up to 6 weeks) and Epoch 2 (up to 35 months)
    End point values
    		 Epoch 1 Epoch 2
    Number of subjects analysed
    23
    19
    Units: Minutes
        arithmetic mean (standard deviation)
    77.6 ± 28.41
    104.1 ± 37.68
    No statistical analyses for this end point

    Secondary: Maximum Infusion Rate per Site

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    End point title
    		 Maximum Infusion Rate per Site
    End point description
    Maximum infusion rate per site was reported. Safety analysis set included all subjects in the full analysis set (enrolled set) who received at least one dose of HyQvia.
    End point type
    Secondary
    End point timeframe
    Epoch 1 (up to 6 weeks) and Epoch 2 (up to 35 months)
    End point values
    		 Epoch 1 Epoch 2
    Number of subjects analysed
    23
    19
    Units: Milliliter per hour (mL/h)
        arithmetic mean (standard deviation)
    253.84 ± 113.952
    181.61 ± 98.932
    No statistical analyses for this end point

    Secondary: Infusion Volume per Site

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    End point title
    		 Infusion Volume per Site
    End point description
    Infusion volume per site was calculated as actual IgG volume (milliliter [mL]) per total number of infusion sites used. Safety analysis set included all subjects in the full analysis set (enrolled set) who received at least one dose of HyQvia.
    End point type
    Secondary
    End point timeframe
    Epoch 1 (up to 6 weeks) and Epoch 2 (up to 35 months)
    End point values
    		 Epoch 1 Epoch 2
    Number of subjects analysed
    23
    19
    Units: milliliter per site
        arithmetic mean (standard deviation)
    101.99 ± 66.388
    162.00 ± 93.988
    No statistical analyses for this end point

    Secondary: Number of Subjects with Infusions that are Discontinued, Slowed, or Interrupted due to an AE

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    End point title
    		 Number of Subjects with Infusions that are Discontinued, Slowed, or Interrupted due to an AE
    End point description
    Number of subjects with infusions that are discontinued, slowed, or interrupted due to an AE were reported. Safety analysis set included all subjects in the full analysis set (enrolled set) who received at least one dose of HyQvia.
    End point type
    Secondary
    End point timeframe
    Epoch 1 (up to 6 weeks) and Epoch 2 (up to 35 months)
    End point values
    		 Epoch 1 Epoch 2
    Number of subjects analysed
    23
    19
    Units: Subjects
    8
    5
    No statistical analyses for this end point

    Secondary: Number of Weeks to Reach Final Dose Interval

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    End point title
    		 Number of Weeks to Reach Final Dose Interval [15]
    End point description
    Final dose interval was defined as three or four weeks infusion interval. Safety analysis set included all subjects in the full analysis set (enrolled Set) who received at least one dose of HyQvia.
    End point type
    Secondary
    End point timeframe
    Epoch 1 (up to 6 weeks) and Epoch 2 (up to 35 months)
    Notes
    [15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data for this endpoint was not planned to be collected and analysed for EPOCH 2 group.
    End point values
    		 Epoch 1
    Number of subjects analysed
    22
    Units: Weeks
        arithmetic mean (standard deviation)
    5.19 ± 1.625
    No statistical analyses for this end point

    Secondary: Health Related Quality of Life (HR QoL): Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9)

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    End point title
    		 Health Related Quality of Life (HR QoL): Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9)
    End point description
    TSQM-9 was a 9-item, validated, self-administered instrument to assess subjects satisfaction with medication. The 3 domains assessed are effectiveness, convenience, and global satisfaction. The score of each of the 3 domains is based on an algorithm to create a score of 0 to 100. Higher score indicated greater satisfaction in that domain.
    End point type
    Secondary
    End point timeframe
    Epoch 1 (up to 6 weeks) and Epoch 2 (up to 35 months)
    End point values
    		 Epoch 1 Epoch 2
    Number of subjects analysed
    0 [16]
    0 [17]
    Units: Score on a scale
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [16] - Data will be reported from the final analysis.
    [17] - Data will be reported from the final analysis.
    No statistical analyses for this end point

    Secondary: HRQoL: Pediatric Quality of Life Questionnaire (PedsQL)

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    End point title
    		 HRQoL: Pediatric Quality of Life Questionnaire (PedsQL)
    End point description
    The Peds-QL was a generic HR QoL instrument designed specifically for a pediatric population. It captures the following domains: general health/activities, feelings/emotional, social functioning, school functioning. For this study, the Peds-QL for 8 to 18-year-old subjects was used. Higher scores indicate better quality of life (QOL) for all domains of the Peds-QL. This modular instrument uses a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, & school functioning) are scored.
    End point type
    Secondary
    End point timeframe
    Epoch 1 (up to 6 weeks) and Epoch 2 (up to 35 months)
    End point values
    		 Epoch 1 Epoch 2
    Number of subjects analysed
    0 [18]
    0 [19]
    Units: Score on a scale
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [18] - Data will be reported from the final analysis.
    [19] - Data will be reported from the final analysis.
    No statistical analyses for this end point

    Secondary: EuroQoL (Quality of Life)-5 Dimensions (EQ-5D)

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    End point title
    		 EuroQoL (Quality of Life)-5 Dimensions (EQ-5D)
    End point description
    EQ-5D considered five attributes of quality of life evaluation, that is, mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension had five possible levels: 1 (no problems); 2 (slight problems); 3 (moderate problems); 4 (severe problems), and; 5 (extreme problems). EQ-5D also included an additional visual analogic scale (EQ-VAS), which ranged from 0 to 100, where 0 indicated worst imaginable health state and 100 was best imaginable health state.
    End point type
    Secondary
    End point timeframe
    Epoch 1 (up to 6 weeks) and Epoch 2 (up to 35 months)
    End point values
    		 Epoch 1 Epoch 2
    Number of subjects analysed
    0 [20]
    0 [21]
    Units: Score on a scale
        arithmetic mean (standard deviation)
    ±
    ±
    Notes
    [20] - Data will be reported from the final analysis.
    [21] - Data will be reported from the final analysis.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From start of study drug administration up to 35 months (Data cut-off date: 14-May-2020)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    Epoch 1
    Reporting group description
    		 Pediatric subjects with PIDD who were on non-HyQvia intravenous (IV) or subcutaneous (SC) treatment with immunoglobulin (IV-pretreated, SC-pretreated) were enrolled and treated with HyQvia (Immune Globulin Infusion 10% [Human] with Recombinant Human Hyaluronidase) SC with a dose or interval ramp-up period of up to 6 weeks. HyQvia was administered at a starting dose of 5 milliliter per hour per site (mL/h/site) to maximum tolerated dose of 80 mL/h/site (for subject with body weight [BW] < 40 kilogram [kg]) or starting dose of 10 mL/h/site to maximum tolerated dose of 240 mL/h/site (for subject with BW greater than or equal to [>=] 40 kg).

    Reporting group title
    Epoch 2
    Reporting group description
    		 Pediatric subjects who were treated with HyQvia prior to this study and those who completed the ramp-up period (Epoch 1) are followed by Epoch 2 with HyQvia treatment. After one year in Epoch 2, subjects with anti-rHuPH20 antibody titer <160 at all time-points during the study will complete the study termination/completion visit at the next possible occasion. Subjects with anti-rHuPH20 antibody titer >= 160 during the study and/or at the last measurement will continue for an additional two years of HyQvia treatment and observation. HyQvia was administered at a starting dose of 10 mL/h/site to maximum tolerated dose of 160 mL/h/site (for subject with body weight [BW] <40kg) or starting dose of 10 mL/h/site to maximum tolerated dose of 300 mL/h/site (for subject with BW >=40kg).

    Serious adverse events
    		 Epoch 1 Epoch 2
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 23 (8.70%)
    4 / 19 (21.05%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Nervous system disorders
    Syncope
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Idiopathic orbital inflammation
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Dental caries
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inflammatory bowel disease
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pharyngitis
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 19 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pilonidal cyst
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 19 (5.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 23 (4.35%)
    0 / 19 (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: 5%
    Non-serious adverse events
    		 Epoch 1 Epoch 2
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    22 / 23 (95.65%)
    14 / 19 (73.68%)
    Investigations
    Blood immunoglobulin G decreased
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Haemangioma
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 23 (4.35%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1
    Radius fracture
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 19 (0.00%)
         occurrences all number
    3
    0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Application site pruritus
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Fatigue
         subjects affected / exposed
    3 / 23 (13.04%)
    1 / 19 (5.26%)
         occurrences all number
    3
    2
    Infusion site erythema
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 19 (0.00%)
         occurrences all number
    2
    0
    Infusion site pain
         subjects affected / exposed
    6 / 23 (26.09%)
    1 / 19 (5.26%)
         occurrences all number
    11
    1
    Infusion site pruritus
         subjects affected / exposed
    4 / 23 (17.39%)
    0 / 19 (0.00%)
         occurrences all number
    6
    0
    Pyrexia
         subjects affected / exposed
    3 / 23 (13.04%)
    3 / 19 (15.79%)
         occurrences all number
    5
    7
    Eye disorders
    Conjunctival haemorrhage
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Eye pain
         subjects affected / exposed
    1 / 23 (4.35%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 23 (4.35%)
    1 / 19 (5.26%)
         occurrences all number
    1
    5
    Inflammatory bowel disease
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    2 / 23 (8.70%)
    1 / 19 (5.26%)
         occurrences all number
    4
    2
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Bronchiectasis
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Cough
         subjects affected / exposed
    8 / 23 (34.78%)
    6 / 19 (31.58%)
         occurrences all number
    13
    12
    Epistaxis
         subjects affected / exposed
    2 / 23 (8.70%)
    2 / 19 (10.53%)
         occurrences all number
    2
    6
    Oropharyngeal pain
         subjects affected / exposed
    2 / 23 (8.70%)
    2 / 19 (10.53%)
         occurrences all number
    4
    2
    Rhinorrhoea
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 19 (0.00%)
         occurrences all number
    2
    0
    Solar urticaria
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Infections and infestations
    Acute sinusitis
         subjects affected / exposed
    1 / 23 (4.35%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1
    Bacterial infection
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Bronchitis
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 19 (0.00%)
         occurrences all number
    2
    0
    Gastroenteritis
         subjects affected / exposed
    5 / 23 (21.74%)
    0 / 19 (0.00%)
         occurrences all number
    7
    0
    Gastroenteritis viral
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 19 (0.00%)
         occurrences all number
    2
    0
    Impetigo
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Lower respiratory tract infection
         subjects affected / exposed
    2 / 23 (8.70%)
    0 / 19 (0.00%)
         occurrences all number
    3
    0
    Nasopharyngitis
         subjects affected / exposed
    5 / 23 (21.74%)
    1 / 19 (5.26%)
         occurrences all number
    6
    1
    Otitis media
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Pharyngotonsillitis
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 19 (5.26%)
         occurrences all number
    0
    1
    Pneumonia
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    2
    Respiratory tract infection
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 19 (10.53%)
         occurrences all number
    0
    2
    Rhinitis
         subjects affected / exposed
    3 / 23 (13.04%)
    6 / 19 (31.58%)
         occurrences all number
    4
    12
    Sinusitis
         subjects affected / exposed
    1 / 23 (4.35%)
    1 / 19 (5.26%)
         occurrences all number
    1
    1
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 23 (0.00%)
    3 / 19 (15.79%)
         occurrences all number
    0
    3
    Viral infection
         subjects affected / exposed
    3 / 23 (13.04%)
    0 / 19 (0.00%)
         occurrences all number
    4
    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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    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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