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    Clinical Trial Results:
    An open-label extension study to assess efficacy, safety and tolerability of canakinumab and the efficacy and safety of childhood vaccinations in patients with Cryopyrin Associated Periodic Syndromes (CAPS)

    Summary
    EudraCT number
    2011-005154-57
    Trial protocol
    BE   FR   ES   DE   GB  
    Global end of trial date
    13 Oct 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    27 Apr 2016
    First version publication date
    27 Apr 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ACZ885D2307E1
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01576367
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    13 Oct 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Oct 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to assess the long-term efficacy of canakinumab with respect to relapse in CAPS patients who completed the CACZ885D2307 study
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    16 Jan 2012
    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
    Spain: 2
    Country: Number of subjects enrolled
    Switzerland: 2
    Country: Number of subjects enrolled
    United Kingdom: 3
    Country: Number of subjects enrolled
    Belgium: 3
    Country: Number of subjects enrolled
    Canada: 1
    Country: Number of subjects enrolled
    France: 1
    Country: Number of subjects enrolled
    Germany: 5
    Worldwide total number of subjects
    17
    EEA total number of subjects
    14
    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)
    4
    Children (2-11 years)
    13
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Patients who complete the CACZ885D2307 study and for whom a parent or legal guardian has signed the informed consent will be eligible to continue canakinumab treatment in the extension. This single treatment arm study will not require treatment assignment of the patients.

    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
    Arm title
    canakinumab
    Arm description
    Patients will receive a standard dose at an equivalent of 2 mg/kg s.c. of canakinumab (ACZ885) every 8 weeks. Possible dose and/or dosing regimen adjustments that can be administered include: 4 mg/kg s.c. (every 4 to 8 weeks) 6 mg/kg s.c. (every 4 to 8 weeks) 8 mg/kg s.c. (every 4 to 8 weeks)
    Arm type
    Experimental

    Investigational medicinal product name
    canakinumab.
    Investigational medicinal product code
    ACZ885D
    Other name
    canakinumab.
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    mg/kg sc of

    Number of subjects in period 1
    canakinumab
    Started
    17
    Completed
    14
    Not completed
    3
         Unsatisfactory therapeutic effect
    2
         Moved to commercial use after 6 months
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    canakinumab
    Reporting group description
    Patients will receive a standard dose at an equivalent of 2 mg/kg s.c. of canakinumab (ACZ885) every 8 weeks. Possible dose and/or dosing regimen adjustments that can be administered include: 4 mg/kg s.c. (every 4 to 8 weeks) 6 mg/kg s.c. (every 4 to 8 weeks) 8 mg/kg s.c. (every 4 to 8 weeks)

    Reporting group values
    canakinumab Total
    Number of subjects
    17 17
    Age categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    4 4
        Children (2-11 years)
    13 13
        Adolescents (12-17 years)
    0 0
        Adults (18-64 years)
    0 0
        From 65-84 years
    0 0
        85 years and over
    0 0
    Age Continuous | Age at start of extension study (years)
    Units: Years
        arithmetic mean (standard deviation)
    3.1 ± 1.7 -
    Gender, Male/Female
    Units: Participants
        Female
    5 5
        Male
    12 12

    End points

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    End points reporting groups
    Reporting group title
    canakinumab
    Reporting group description
    Patients will receive a standard dose at an equivalent of 2 mg/kg s.c. of canakinumab (ACZ885) every 8 weeks. Possible dose and/or dosing regimen adjustments that can be administered include: 4 mg/kg s.c. (every 4 to 8 weeks) 6 mg/kg s.c. (every 4 to 8 weeks) 8 mg/kg s.c. (every 4 to 8 weeks)

    Primary: The percentage of participants without disease relapse as determined by the Physician's global assessment of autoinflammatory disease activity, assessment of skin disease and serological inflammation markers.

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    End point title
    The percentage of participants without disease relapse as determined by the Physician's global assessment of autoinflammatory disease activity, assessment of skin disease and serological inflammation markers. [1]
    End point description
    Disease relapse following complete response is defined as inflammation markers: C-Reactive Protein (CRP) and/or Serum Amyloid A (SAA) result > 30 mg/L AND Physician's Global Assessment of Autoinflammatory Disease Activity > minimal or Physician's Global Assessment >= minimal AND Skin Disease Assessment > minimal. Physician's Global Assessment of Autoinflammatory Disease Activity and Skin Disease Assessment (urticarial skin rash) are completed by the investigator using a 5 point rating scale: absent, minimal, mild, moderate and severe. No statistical analysis was planned for this primary outcome.
    End point type
    Primary
    End point timeframe
    Week /80, 104, 128, and 152 (A minimum of 6 months and maximum of 24 months)
    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 analysis was planned for this primary outcome
    End point values
    canakinumab
    Number of subjects analysed
    17
    Units: Percentage of participants
        number (not applicable)
    94.1
    No statistical analyses for this end point

    Secondary: Immunogenicity of Canakinumab (ACZ885). Number of participants with anti-canakinumab antibodies

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    End point title
    Immunogenicity of Canakinumab (ACZ885). Number of participants with anti-canakinumab antibodies
    End point description
    Immunogenicity assessment included determination of anti-canakinumab (ACZ885) antibodies in serum samples using BIAcore system, with detection based on surface plasmon resonance technique.
    End point type
    Secondary
    End point timeframe
    minimum of 6 months and maximum of 24 months
    End point values
    canakinumab
    Number of subjects analysed
    15
    Units: Participants
    0
    No statistical analyses for this end point

    Secondary: Change from baseline (core study baseline) in C­-Reactive Protein (CRP) and Serum Amyloid A (SAA) concentrations

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    End point title
    Change from baseline (core study baseline) in C­-Reactive Protein (CRP) and Serum Amyloid A (SAA) concentrations
    End point description
    CRP and SAA were used as serologic inflammatory markers. The target level concentrations for CRP and SAA was ≤15 mg/L and ≤10 mg/L, respectively. Negative change in concentration of inflammatory markers indicated improvement.
    End point type
    Secondary
    End point timeframe
    Week 0, 80, 104, 128 and 152, last assessment
    End point values
    canakinumab
    Number of subjects analysed
    17
    Units: (mg/L)
    arithmetic mean (standard deviation)
        CRP at Core End of Study (last assessment) (n=14)
    -5.4 ± 6.28
        CRP at week 80 (n=16)
    -14.7 ± 35.8
        CRP at Week 104 (n=11)
    -3.8 ± 14.4
        CRP at Week 128(n=12)
    -4.1 ± 10.3
        CRP at Week 152 (n=12)
    -4.3 ± 11
        CRP at End of Study (last assessment) (n=16)
    -10.4 ± 30.3
        SAA at Core End of Study (last assessment) (n=16)
    -54.4 ± 133.8
        SAA at Week 80 (n=12)
    -79.1 ± 224.1
        SAA at week 104 (n=11)
    15.8 ± 158.1
        SAA at week 128 (n=10)
    -28.2 ± 47.4
        SAA at week 152 (n=11)
    -6.4 ± 60
        SAA at End of Study (last assessment) (n=15)
    -58.5 ± 183.6
    No statistical analyses for this end point

    Secondary: Frequency counts of physician’s global assessment of autoinflammatory disease and skin disease

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    End point title
    Frequency counts of physician’s global assessment of autoinflammatory disease and skin disease
    End point description
    Participants were assessed based by physician on Physician's Global Assessment measured on a 5­-point scale for auto inflammatory disease activity as: 0 = None/absent; 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe
    End point type
    Secondary
    End point timeframe
    minimum of 6 months and maximum of 24 months
    End point values
    canakinumab
    Number of subjects analysed
    17
    Units: Percentage of participants
    number (not applicable)
        Assessment of autoinflammatory disease (Absent)
    64.7
        Assessment of autoinflammatory disease (Minimal)
    29.4
        Assessment of autoinflammatory disease (Mild)
    5.9
        Assessment of autoinflammatory disease (Moderate)
    0
        Assessment of autoinflammatory disease (Severe)
    0
        Assessment of skin disease (Absent)
    94.1
        Assessment of skin disease (Minimal)
    0
        Assessment of skin disease (Mild)
    5.9
        Assessment of skin disease (Moderate)
    0
        Assessment of skin disease (Severe)
    0
    No statistical analyses for this end point

    Secondary: Number of vaccination cases with protective antibody levels following immunization with inactivated vaccines

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    End point title
    Number of vaccination cases with protective antibody levels following immunization with inactivated vaccines
    End point description
    Participants who received any inactivated vaccines during the study were assessed for their ability to attain protective antibody levels against the vaccine (antigen) post immunization. Participants vaccinations were not assessed for a response if the antibody titre was already sufficient at pre-dose and maintained during the study.
    End point type
    Secondary
    End point timeframe
    pre-vaccine dose, Day 28 post-vaccine
    End point values
    canakinumab
    Number of subjects analysed
    4
    Units: vaccination cases
        Positive response for antibody levels
    16
        No pre-dose antibody levels
    3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    ACZ885
    Reporting group description
    ACZ885

    Serious adverse events
    ACZ885
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 17 (47.06%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Limb injury
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Haematoma
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Papillitis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ear and labyrinth disorders
    Conductive deafness
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Meningitis aseptic
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences causally related to treatment / all
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    ACZ885
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    16 / 17 (94.12%)
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    6 / 17 (35.29%)
         occurrences all number
    12
    Immune system disorders
    Milk allergy
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Seasonal allergy
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Breast pain
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Vulvovaginal burning sensation
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    5 / 17 (29.41%)
         occurrences all number
    16
    Epistaxis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Oropharyngeal pain
         subjects affected / exposed
    3 / 17 (17.65%)
         occurrences all number
    4
    Productive cough
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Rhinorrhoea
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Investigations
    Body temperature increased
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    C-reactive protein increased
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    3
    CSF white blood cell count increased
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Serum amyloid A protein increased
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    3
    Transaminases increased
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Tympanometry abnormal
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Craniocerebral injury
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Congenital, familial and genetic disorders
    Cryopyrin associated periodic syndrome
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    3
    Nervous system disorders
    Burning sensation
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Cerebral ventricle dilatation
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Headache
         subjects affected / exposed
    6 / 17 (35.29%)
         occurrences all number
    16
    Hemiplegia
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Lethargy
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Loss of consciousness
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Motor developmental delay
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Pyramidal tract syndrome
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Seizure
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Speech disorder developmental
         subjects affected / exposed
    3 / 17 (17.65%)
         occurrences all number
    3
    Blood and lymphatic system disorders
    Eosinophilia
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Conductive deafness
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    2
    Ear pain
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    4
    Eye disorders
    Eye pruritus
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Papilloedema
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    3
    Iridocyclitis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Uveitis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    33
    Abdominal pain upper
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    8
    Aphthous stomatitis
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    5
    Diarrhoea
         subjects affected / exposed
    7 / 17 (41.18%)
         occurrences all number
    9
    Gingival hypertrophy
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Mouth ulceration
         subjects affected / exposed
    3 / 17 (17.65%)
         occurrences all number
    5
    Nausea
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Toothache
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    6 / 17 (35.29%)
         occurrences all number
    8
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Dermatitis diaper
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Dry skin
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Eczema
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    4
    Hypersensitivity vasculitis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Prurigo
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    2
    Pruritus
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    2
    Pruritus generalised
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    2
    Rash
         subjects affected / exposed
    5 / 17 (29.41%)
         occurrences all number
    5
    Skin lesion
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Rash maculo-papular
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Urticaria
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Renal and urinary disorders
    Hypertonic bladder
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Joint swelling
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Pain in extremity
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    6
    Infections and infestations
    Abscess limb
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Bronchitis
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    4
    Cellulitis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Cystitis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Ear infection
         subjects affected / exposed
    3 / 17 (17.65%)
         occurrences all number
    3
    Eczema infected
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Enterobiasis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Gastroenteritis
         subjects affected / exposed
    4 / 17 (23.53%)
         occurrences all number
    4
    Hand-foot-and-mouth disease
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Impetigo
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Laryngitis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    2
    Lice infestation
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    2
    Meningitis aseptic
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Molluscum contagiosum
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Nasopharyngitis
         subjects affected / exposed
    7 / 17 (41.18%)
         occurrences all number
    17
    Oral herpes
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    2
    Otitis media
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Paronychia
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Pharyngitis streptococcal
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Pneumonia
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Rhinitis
         subjects affected / exposed
    4 / 17 (23.53%)
         occurrences all number
    12
    Tonsillitis
         subjects affected / exposed
    3 / 17 (17.65%)
         occurrences all number
    3
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 17 (23.53%)
         occurrences all number
    5
    Urinary tract infection
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Varicella
         subjects affected / exposed
    3 / 17 (17.65%)
         occurrences all number
    3
    Vulval abscess
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    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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