Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Double-blind, Placebo-controlled, Randomized Phase III Pivotal Trial to Assess the Efficacy and Safety of Peanut Epicutaneous Immunotherapy with Viaskin® Peanut in Peanut-allergic Children (PEPITES Study)

    Summary
    EudraCT number
    		 2015-002461-37
    Trial protocol
    		 IE   DE  
    Global end of trial date
    18 Aug 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Sep 2021
    First version publication date
    15 Sep 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    V712-301
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02636699
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    DBV Technologies
    Sponsor organisation address
    177-181 avenue Pierre Brossolette, Montrouge, France, 92120
    Public contact
    Chief Medical Officer, DBV Technologies, 33 1-55-42-78-78, clinicaltrials@dbv-technologies.com
    Scientific contact
    Chief Medical Officer, DBV Technologies, 33 1-55-42-78-78, clinicaltrials@dbv-technologies.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001481-PIP01-13
    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
    18 Aug 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Aug 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy and safety of DBV712 (Viaskin® Peanut) to induce desensitization to peanut in peanut-allergic participants aged 4 to 11 years old after a 12-month treatment period by epicutaneous immunotherapy.
    Protection of trial subjects
    This study was designed and conducted in accordance with the International Council for Harmonisation Good Clinical Practice, as required by the major Regulatory Authorities, and in accordance with the ethical principles of the Declaration of Helsinki. The study was also carried out in keeping with local legal requirements. The study was conducted with Investigators and staff who were trained and experienced in the diagnosis and management of peanut allergy and anaphylaxis, and equipped and capable of performing a double-blind, placebo-controlled food challenge (DBPCFC) in children.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Jan 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Australia: 24
    Country: Number of subjects enrolled
    Canada: 89
    Country: Number of subjects enrolled
    Germany: 29
    Country: Number of subjects enrolled
    Ireland: 20
    Country: Number of subjects enrolled
    United States: 194
    Worldwide total number of subjects
    356
    EEA total number of subjects
    49
    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)
    356
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 This Phase III study was conducted in participants aged 4 to 11 years old with peanut allergy at 31 active centers in Australia, Canada, Germany, Ireland and USA. Participants were randomized in a 2:1 ratio to receive DBV712 250 micrograms (μg) or placebo.

    Pre-assignment
    Screening details
    		 Overall maximum study duration for each participant was approximately 61 weeks (6-week screening period, 53-week treatment period and 2-week follow-up period). During the screening period, participants underwent a DBPCFC up to a highest dose of 300 milligrams (mg) peanut protein to confirm their allergy and their entry peanut eliciting dose (ED).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor
    Blinding implementation details
    DBV712 250 μg and placebo patches were supplied in identical pouches and were similar in physical appearance, thereby enabling double-blind conditions.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 DBV712 250 μg
    Arm description
    		 Participants applied 1 new DBV712 250 μg patch for 24 hours (±4 hours) every day for 12 months. The application duration was progressively increased to a duration of 24 hours daily over a 15-day period (6 hours during the first week, 12 hours during the second week and 24 hours from the third week onwards).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Viaskin Peanut
    Investigational medicinal product code
    DBV712
    Other name
    Pharmaceutical forms
    Cutaneous patch
    Routes of administration
    Cutaneous use
    Dosage and administration details
    The active treatment, DBV712, is a cutaneous patch (DBV712 patch) containing a dry deposit of a formulation of peanut protein extract. The drug substance is an unmodified, lyophilized peanut extract produced from the extraction and freeze drying of defatted peanut flour. Application of the DBV712 patch at a similar time for each daily application (morning or evening) was recommended.

    Arm title
    		 Placebo
    Arm description
    		 Participants applied 1 new placebo patch for 24 hours (±4 hours) every day for 12 months. The application duration was progressively increased to a duration of 24 hours daily over a 15-day period (6 hours during the first week, 12 hours during the second week and 24 hours from the third week onwards).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cutaneous patch
    Routes of administration
    Cutaneous use
    Dosage and administration details
    The placebo treatment consists of a matching cutaneous patch and dry deposit formulation, in which the peanut proteins were replaced by mannitol. Application of the placebo patch at a similar time for each daily application (morning or evening) was recommended.

    Number of subjects in period 1
    		DBV712 250 μg Placebo
    Started
    238
    118
    Completed
    213
    107
    Not completed
    25
    11
         Non-compliance with investigational product (IP)
    2
    -
         Physician decision
    -
    1
         Adverse Event
    4
    -
         Withdrawal by Subject
    13
    6
         Unspecified
    3
    1
         Lost to follow-up
    3
    3

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    DBV712 250 μg
    Reporting group description
    		 Participants applied 1 new DBV712 250 μg patch for 24 hours (±4 hours) every day for 12 months. The application duration was progressively increased to a duration of 24 hours daily over a 15-day period (6 hours during the first week, 12 hours during the second week and 24 hours from the third week onwards).

    Reporting group title
    Placebo
    Reporting group description
    		 Participants applied 1 new placebo patch for 24 hours (±4 hours) every day for 12 months. The application duration was progressively increased to a duration of 24 hours daily over a 15-day period (6 hours during the first week, 12 hours during the second week and 24 hours from the third week onwards).

    Reporting group values
    		 DBV712 250 μg Placebo Total
    Number of subjects
    		 238 118 356
    Age categorical
    Units: Subjects
        4 to 5 years
    		 55 32 87
        6 to 11 years
    		 183 86 269
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 7.4 ± 2.11 7.3 ± 2.30 -
    Gender categorical
    Units: Subjects
        Female
    		 89 49 138
        Male
    		 149 69 218
    Race
    Units: Subjects
        White
    		 194 96 290
        Black or African American
    		 1 2 3
        Asian
    		 19 8 27
        Other
    		 24 12 36
    Screening ED Subgroup
    Screening ED Subgroup 1: participants with a screening ED of 1 mg, 3 mg or 10 mg peanut protein. Screening ED Subgroup 2: participants with a screening ED of 30 mg, 100 mg or 300 mg peanut protein.
    Units: Subjects
        Screening ED Subgroup 1
    		 41 20 61
        Screening ED Subgroup 2
    		 197 98 295

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    DBV712 250 μg
    Reporting group description
    		 Participants applied 1 new DBV712 250 μg patch for 24 hours (±4 hours) every day for 12 months. The application duration was progressively increased to a duration of 24 hours daily over a 15-day period (6 hours during the first week, 12 hours during the second week and 24 hours from the third week onwards).

    Reporting group title
    Placebo
    Reporting group description
    		 Participants applied 1 new placebo patch for 24 hours (±4 hours) every day for 12 months. The application duration was progressively increased to a duration of 24 hours daily over a 15-day period (6 hours during the first week, 12 hours during the second week and 24 hours from the third week onwards).

    Primary: Difference in Percentage of Treatment Responders at Month 12; Analyzed in the Overall Population

    		 Close Top of page
    End point title
    		 Difference in Percentage of Treatment Responders at Month 12; Analyzed in the Overall Population
    End point description
    The DBPCFCs to determine ED were performed at screening and Month 12, with each challenge occurring over 2 days. The participant was gradually fed increasing amounts of standardized blinded oral formulas containing either peanut protein (during 1 of the 2 days of the challenge), or without any peanut protein (during the other day of the challenge). A participant was defined as a treatment responder if: • ED was ≥300 mg peanut protein at Month 12 DBPCFC (for screening ED subgroup 1), or • ED was ≥1,000 mg peanut protein at Month 12 DBPCFC (for screening ED subgroup 2). Participants with missing treatment response at Month 12 were imputed as non-responders. The percentage of treatment responders at Month 12 is presented. Analysis was performed in the overall population. The intent-to-treat (ITT) population was comprised of all participants who were randomized.
    End point type
    Primary
    End point timeframe
    At Month 12
    End point values
    		 DBV712 250 μg Placebo
    Number of subjects analysed
    238
    118
    Units: percentage of participants
        number (confidence interval 95%)
    35.3 (29.5 to 41.6)
    13.6 (8.5 to 20.9)
    Statistical analysis title
    		 DBV712 versus Placebo
    Statistical analysis description
    Analysis of the difference in response rates between DBV712 250 μg group and Placebo group and 2-sided Newcombe 95% confidence interval (CI). P-value was obtained from a 2-sided 5% test to evaluate the null hypothesis of no difference in response rates between treatment groups using the Wald method. Clinical relevance was evaluated based on the lower bound of the Newcombe 95% CI of the difference in response rates ≥15%.
    Comparison groups
    DBV712 250 μg v Placebo
    Number of subjects included in analysis
    356
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Wald
    Parameter type
    		 Difference in Response Rates (%)
    Point estimate
    21.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 12.4
         upper limit
    		 29.8

    Secondary: Difference in Percentages of Treatment Responders at Month 12; Analyzed in Each Screening ED Subgroup

    		 Close Top of page
    End point title
    		 Difference in Percentages of Treatment Responders at Month 12; Analyzed in Each Screening ED Subgroup
    End point description
    The DBPCFCs to determine ED were performed at screening and Month 12, with each challenge occurring over 2 days. The participant was gradually fed increasing amounts of blinded oral formulas containing either peanut protein (during 1 of the 2 days of the challenge), or without any peanut protein (during the other day of the challenge). A participant was defined as a treatment responder if: • ED was ≥300 mg peanut protein at Month 12 DBPCFC (for screening ED subgroup 1), or • ED was ≥1,000 mg peanut protein at Month 12 DBPCFC (for screening ED subgroup 2). Participants with missing treatment response at Month 12 were imputed as non-responders. The percentage of treatment responders at Month 12 is presented below. Analysis was performed for each separate screening ED subgroup. The ITT population was comprised of all participants who were randomized. 'n' denotes number of participants analyzed in each screening ED subgroup.
    End point type
    Secondary
    End point timeframe
    At Month 12
    End point values
    		 DBV712 250 μg Placebo
    Number of subjects analysed
    238
    118
    Units: percentage of participants
    number (confidence interval 95%)
        Screening ED subgroup 1 (n = 41, 20)
    39.0 (25.7 to 54.3)
    20.0 (8.1 to 41.6)
        Screening ED subgroup 2 (n = 197, 98)
    34.5 (28.2 to 41.4)
    12.2 (7.1 to 20.2)
    Statistical analysis title
    		 DBV712 versus Placebo (Screening ED subgroup 1)
    Statistical analysis description
    Analysis of the difference in response rates between DBV712 250 μg group and Placebo group and 2-sided Newcombe 95% CI. P-value was obtained from a 2-sided 5% test to evaluate the null hypothesis of no difference in response rates between treatment groups using the Wald method. Clinical relevance was evaluated based on the lower bound of the Newcombe 95% CI of the difference in response rates >0.
    Comparison groups
    DBV712 250 μg v Placebo
    Number of subjects included in analysis
    356
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.105
    Method
    		 Wald
    Parameter type
    		 Difference in Response Rates (%)
    Point estimate
    19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.4
         upper limit
    		 38.4
    Statistical analysis title
    		 DBV712 versus Placebo (Screening ED subgroup 2)
    Statistical analysis description
    Analysis of the difference in response rates between DBV712 250 μg group and Placebo group and 2-sided Newcombe 95% CI. P-value was obtained from a 2-sided 5% test to evaluate the null hypothesis of no difference in response rates between treatment groups using the Wald method. Clinical relevance was evaluated based on the lower bound of the Newcombe 95% CI of the difference in response rates >0.
    Comparison groups
    DBV712 250 μg v Placebo
    Number of subjects included in analysis
    356
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Wald
    Parameter type
    		 Difference in Response Rates (%)
    Point estimate
    22.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 12.1
         upper limit
    		 30.8

    Secondary: Cumulative Reactive Dose (CRD) of Peanut Protein at Baseline and Month 12

    		 Close Top of page
    End point title
    		 Cumulative Reactive Dose (CRD) of Peanut Protein at Baseline and Month 12
    End point description
    The CRD was calculated as the sum of all doses given (including any repeated and partial doses). The median CRD of peanut protein at baseline and Month 12 is presented. Analysis was performed using the modified baseline observation carried forward method to impute missing data at Month 12. The ITT population was comprised of all participants who were randomized.
    End point type
    Secondary
    End point timeframe
    Baseline and Month 12
    End point values
    		 DBV712 250 μg Placebo
    Number of subjects analysed
    238
    118
    Units: mg
    median (inter-quartile range (Q1-Q3))
        Baseline
    144.0 (44.0 to 444.0)
    144.0 (44.0 to 444.0)
        Month 12
    444.0 (144.0 to 1444.0)
    144.0 (44.0 to 444.0)
    Statistical analysis title
    		 DBV712 versus Placebo
    Statistical analysis description
    The treatment effect was estimated using the Hodges-Lehmann estimate of the difference in median CRDs at Month 12.
    Comparison groups
    Placebo v DBV712 250 μg
    Number of subjects included in analysis
    356
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Wilcoxon rank-sum test
    Parameter type
    		 Difference in Median CRD
    Point estimate
    297
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 130
         upper limit
    		 317

    Secondary: Relative Change From Baseline in Peanut-specific Immunoglobulin E (IgE) Over Time

    		 Close Top of page
    End point title
    		 Relative Change From Baseline in Peanut-specific Immunoglobulin E (IgE) Over Time
    End point description
    Venous blood samples were drawn to assess peanut-specific IgE levels at baseline and Months 3, 6 and 12. The median relative changes from baseline in IgE levels for each timepoint are presented. Relative change from baseline=100×(value at the visit–value at baseline)/value at baseline. The ITT population was comprised of all participants who were randomized. Only those with non-missing data were included in the analysis. 'n' denotes number of participants analyzed for each timepoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 3, 6 and 12
    End point values
    		 DBV712 250 μg Placebo
    Number of subjects analysed
    238
    118
    Units: Relative change (percentage)
    median (inter-quartile range (Q1-Q3))
        Month 3 (n = 232, 115)
    78.716 (26.557 to 174.588)
    16.964 (-12.591 to 48.802)
        Month 6 (n = 229, 111)
    39.716 (-3.676 to 109.690)
    4.605 (-26.380 to 30.352)
        Month 12 (n = 224, 108)
    2.858 (-24.739 to 61.058)
    -6.919 (-31.468 to 25.291)
    No statistical analyses for this end point

    Secondary: Relative Changes From Baseline in Peanut-specific Immunoglobulin G4 Subtype (IgG4) Over Time

    		 Close Top of page
    End point title
    		 Relative Changes From Baseline in Peanut-specific Immunoglobulin G4 Subtype (IgG4) Over Time
    End point description
    Venous blood samples were drawn to assess peanut-specific IgG4 levels at baseline and Months 3, 6 and 12. The median relative changes from baseline in IgG4 levels for each timepoint are presented. Relative change from baseline=100×(value at the visit–value at baseline)/value at baseline. The ITT population was comprised of all participants who were randomized. Only those with non-missing data were included in the analysis. 'n' denotes number of participants analyzed for each timepoint.
    End point type
    Secondary
    End point timeframe
    Baseline and Months 3, 6 and 12
    End point values
    		 DBV712 250 μg Placebo
    Number of subjects analysed
    238
    118
    Units: Relative change (percentage)
    median (inter-quartile range (Q1-Q3))
        Month 3 (n = 231, 115)
    127.778 (55.660 to 259.615)
    14.286 (0.000 to 45.833)
        Month 6 (n = 229, 110)
    258.491 (107.843 to 549.351)
    11.492 (-9.677 to 42.105)
        Month 12 (n = 224, 109)
    513.487 (196.458 to 1105.235)
    10.496 (-10.108 to 33.333)
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Treatment-emergent adverse events (TEAEs) were collected from Day 1, throughout the 53-week treatment period and additional 2-week follow-up period. Overall time frame of up to 55 weeks.
    Adverse event reporting additional description
    The safety population was comprised of all participants who were randomized and received at least 1 dose of IP. Adverse events occurring after the end of the treatment period were recorded only if the Investigator considered there was a causal relationship with the IP and as such, were considered also as TEAEs.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    DBV712 250 μg
    Reporting group description
    		 Participants applied 1 new DBV712 250 μg patch for 24 hours (±4 hours) every day for 12 months. The application duration was progressively increased to a duration of 24 hours daily over a 15-day period (6 hours during the first week, 12 hours during the second week and 24 hours from the third week onwards).

    Reporting group title
    Placebo
    Reporting group description
    		 Participants applied 1 new placebo patch for 24 hours (±4 hours) every day for 12 months. The application duration was progressively increased to a duration of 24 hours daily over a 15-day period (6 hours during the first week, 12 hours during the second week and 24 hours from the third week onwards).

    Serious adverse events
    		 DBV712 250 μg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 238 (4.20%)
    6 / 118 (5.08%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    6 / 238 (2.52%)
    3 / 118 (2.54%)
         occurrences causally related to treatment / all
    4 / 7
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Food allergy
         subjects affected / exposed
    1 / 238 (0.42%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Visual impairment
         subjects affected / exposed
    0 / 238 (0.00%)
    1 / 118 (0.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Coeliac disease
         subjects affected / exposed
    0 / 238 (0.00%)
    1 / 118 (0.85%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Throat irritation
         subjects affected / exposed
    1 / 238 (0.42%)
    0 / 118 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wheezing
         subjects affected / exposed
    1 / 238 (0.42%)
    0 / 118 (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
    Appendicitis
         subjects affected / exposed
    1 / 238 (0.42%)
    1 / 118 (0.85%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    1 / 238 (0.42%)
    0 / 118 (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
    		 DBV712 250 μg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    222 / 238 (93.28%)
    96 / 118 (81.36%)
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    8 / 238 (3.36%)
    6 / 118 (5.08%)
         occurrences all number
    9
    7
    Limb injury
         subjects affected / exposed
    1 / 238 (0.42%)
    6 / 118 (5.08%)
         occurrences all number
    1
    6
    Nervous system disorders
    Headache
         subjects affected / exposed
    39 / 238 (16.39%)
    18 / 118 (15.25%)
         occurrences all number
    74
    41
    General disorders and administration site conditions
    Application site eczema
         subjects affected / exposed
    25 / 238 (10.50%)
    6 / 118 (5.08%)
         occurrences all number
    29
    18
    Application site erythema
         subjects affected / exposed
    67 / 238 (28.15%)
    20 / 118 (16.95%)
         occurrences all number
    118
    54
    Application site pruritus
         subjects affected / exposed
    83 / 238 (34.87%)
    14 / 118 (11.86%)
         occurrences all number
    154
    30
    Application site reaction
         subjects affected / exposed
    21 / 238 (8.82%)
    2 / 118 (1.69%)
         occurrences all number
    29
    5
    Application site swelling
         subjects affected / exposed
    38 / 238 (15.97%)
    2 / 118 (1.69%)
         occurrences all number
    86
    18
    Application site urticaria
         subjects affected / exposed
    16 / 238 (6.72%)
    0 / 118 (0.00%)
         occurrences all number
    24
    0
    Pyrexia
         subjects affected / exposed
    48 / 238 (20.17%)
    22 / 118 (18.64%)
         occurrences all number
    63
    34
    Immune system disorders
    Allergy to animal
         subjects affected / exposed
    8 / 238 (3.36%)
    8 / 118 (6.78%)
         occurrences all number
    11
    16
    Food allergy
         subjects affected / exposed
    21 / 238 (8.82%)
    9 / 118 (7.63%)
         occurrences all number
    29
    14
    Anaphylactic reaction
         subjects affected / exposed
    12 / 238 (5.04%)
    4 / 118 (3.39%)
         occurrences all number
    12
    4
    Hypersensitivity
         subjects affected / exposed
    22 / 238 (9.24%)
    6 / 118 (5.08%)
         occurrences all number
    29
    8
    Seasonal allergy
         subjects affected / exposed
    20 / 238 (8.40%)
    5 / 118 (4.24%)
         occurrences all number
    30
    9
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    17 / 238 (7.14%)
    3 / 118 (2.54%)
         occurrences all number
    19
    4
    Abdominal pain
         subjects affected / exposed
    10 / 238 (4.20%)
    7 / 118 (5.93%)
         occurrences all number
    16
    12
    Vomiting
         subjects affected / exposed
    31 / 238 (13.03%)
    10 / 118 (8.47%)
         occurrences all number
    42
    12
    Diarrhoea
         subjects affected / exposed
    14 / 238 (5.88%)
    3 / 118 (2.54%)
         occurrences all number
    18
    4
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    30 / 238 (12.61%)
    16 / 118 (13.56%)
         occurrences all number
    78
    28
    Cough
         subjects affected / exposed
    52 / 238 (21.85%)
    15 / 118 (12.71%)
         occurrences all number
    97
    27
    Oropharyngeal pain
         subjects affected / exposed
    16 / 238 (6.72%)
    8 / 118 (6.78%)
         occurrences all number
    24
    12
    Nasal congestion
         subjects affected / exposed
    21 / 238 (8.82%)
    10 / 118 (8.47%)
         occurrences all number
    34
    16
    Rhinitis allergic
         subjects affected / exposed
    27 / 238 (11.34%)
    9 / 118 (7.63%)
         occurrences all number
    50
    14
    Wheezing
         subjects affected / exposed
    18 / 238 (7.56%)
    9 / 118 (7.63%)
         occurrences all number
    26
    10
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    27 / 238 (11.34%)
    9 / 118 (7.63%)
         occurrences all number
    36
    31
    Rash
         subjects affected / exposed
    18 / 238 (7.56%)
    5 / 118 (4.24%)
         occurrences all number
    24
    5
    Urticaria
         subjects affected / exposed
    21 / 238 (8.82%)
    15 / 118 (12.71%)
         occurrences all number
    29
    25
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    20 / 238 (8.40%)
    10 / 118 (8.47%)
         occurrences all number
    23
    11
    Gastroenteritis viral
         subjects affected / exposed
    15 / 238 (6.30%)
    3 / 118 (2.54%)
         occurrences all number
    17
    5
    Pharyngitis streptococcal
         subjects affected / exposed
    16 / 238 (6.72%)
    5 / 118 (4.24%)
         occurrences all number
    23
    5
    Influenza
         subjects affected / exposed
    7 / 238 (2.94%)
    6 / 118 (5.08%)
         occurrences all number
    8
    6
    Sinusitis
         subjects affected / exposed
    17 / 238 (7.14%)
    3 / 118 (2.54%)
         occurrences all number
    20
    3
    Upper respiratory tract infection
         subjects affected / exposed
    73 / 238 (30.67%)
    30 / 118 (25.42%)
         occurrences all number
    134
    48
    Viral infection
         subjects affected / exposed
    19 / 238 (7.98%)
    3 / 118 (2.54%)
         occurrences all number
    21
    3
    Viral upper respiratory tract infection
         subjects affected / exposed
    42 / 238 (17.65%)
    20 / 118 (16.95%)
         occurrences all number
    82
    40

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Dec 2015
    Sections affected by important changes in the protocol as per amendment 1: - Study design - Efficacy endpoints - Safety endpoints - Exploratory endpoints - Inclusion criteria - Exclusion criteria - Criteria for withdrawal from IP and study - Prohibited prior and concomitant medication - DBPCFC stopping rules - Safety criteria - Statistical methods.

    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
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Mon Apr 29 11:41:26 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA