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    Clinical Trial Results:
    A Phase 2a Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Immunogenicity, and Efficacy of Bris10 M2SR (H3N2 A/Brisbane/10/2007) Vaccine Administered as a Single Intranasal Dose (Versus Placebo) in Healthy Adult Volunteers who are Subsequently Challenged with a Live, Antigenically Different Wild-type Influenza Type A Virus (A/Belgium/4217/2015 H3N2)

    Summary
    EudraCT number
    2017-004971-30
    Trial protocol
    BE  
    Global end of trial date
    06 Mar 2019

    Results information
    Results version number
    v1(current)
    This version publication date
    19 Mar 2020
    First version publication date
    19 Mar 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    FLUGEN-H3N2-V002
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    FluGen Inc.
    Sponsor organisation address
    597 Science Drive, Madison, United States, WI USA 53711
    Public contact
    Pamuk Bilsel, FluGen, Inc, 001 608-442-6562, pbilsel@flugen.com
    Scientific contact
    Pamuk Bilsel, FluGen, Inc, 001 608-442-6562, pbilsel@flugen.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
    Final
    Date of interim/final analysis
    06 Mar 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Mar 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • Assess the effect of vaccination with Bris10/2007 M2SR (H3N2) vaccine on influenza viral shedding after intranasal challenge with a drifted H3N2 virus, A/Belgium/4217/2015. • Assess the safety of the Bris10 M2SR (H3N2) vaccine during the period from study vaccine administration until influenza virus challenge.
    Protection of trial subjects
    This study was conducted in compliance with the protocol, the ICH Note for Guidance on Good Clinical Practice (CMPM/ICH/135/95) and with the applicable regulatory requirement(s)
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    15 May 2018
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety
    Long term follow-up duration
    6 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 108
    Worldwide total number of subjects
    108
    EEA total number of subjects
    108
    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)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    108
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted in the SGS clinical pharmacology phase 1 unit in Antwerp, Belgium.

    Pre-assignment
    Screening details
    Screening for eligible, healthy male and non-pregnant female subjects who were 18 to 55 years old was performed within approximately 7 weeks prior to randomization/vaccine administration. A total of 108 subjects were randomized into the study and were vaccinated (56 placebo, 52 Bris10 M2SR), according to randomization.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator
    Blinding implementation details
    All subjects underwent the same procedures. The unblinded pharmacy staff or delegate prepared doses (active and placebo), filled delivery devices, and applied an opaque label to the device barrel to obscure any coloration of the contents. The unblinded site staff and unblinded monitor agreed in writing to maintain the blind by not providing details of the dose (active or placebo) to any blinded clinic staff including the investigator or any study subjects.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Subjects randomized to and receiving placebo
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Intranasal use
    Dosage and administration details
    The reference product (placebo) used in this study was a physiological saline suitable for intranasal delivery. Commercially available supplies of placebo (0.9% NaCl 10 mL) were used and supplied by the site following approval from the Sponsor. The placebo was drawn into a nasal sprayer for intranasal delivery. Doses of placebo were administered according to the same procedures as Bris10 M2SR vaccine.

    Arm title
    BRIS10 M2SR
    Arm description
    Subjects randomized to and receiving BRIS10 M2SR
    Arm type
    Experimental

    Investigational medicinal product name
    FluGen’s H3N2 (A/Brisbane/10/2007) M2SR Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Intranasal use
    Dosage and administration details
    The vaccine was provided frozen and in single-use cryovials. An unblinded pharmacist thawed the vial contents to room temperature just prior to dose administration. The contents were diluted to the dosing concentration with provided diluent for each subject. The final diluted product was drawn into a nasal sprayer for intranasal delivery.

    Number of subjects in period 1
    Placebo BRIS10 M2SR
    Started
    56
    52
    Completed
    51
    48
    Not completed
    5
    4
         due to excl criteria 1 in part B
    4
    3
         Due to bed capacity
    -
    1
         Consent withdrawn by subject
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects randomized to and receiving placebo

    Reporting group title
    BRIS10 M2SR
    Reporting group description
    Subjects randomized to and receiving BRIS10 M2SR

    Reporting group values
    Placebo BRIS10 M2SR Total
    Number of subjects
    56 52 108
    Age categorical
    Units: Subjects
        Adults (18-55 years)
    56 52 108
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    38.9 ± 11.84 39.6 ± 9.68 -
    Gender categorical
    Units: Subjects
        Female
    21 21 42
        Male
    35 31 66
    Race
    Units: Subjects
        Asian
    0 1 1
        Black or African American
    1 1 2
        White
    55 50 105
    Ethnicity
    Units: Subjects
        Not Hispanic or Latino
    56 52 108
    Age categorical
    Units: Subjects
        Age ≤ 50 yrs
    44 44 88
        Age > 50 yrs
    12 8 20
    Smoking status
    Units: Subjects
        Ex-Smoker
    13 16 29
        Non-Smoker
    42 34 76
        Smoker
    1 2 3
    Age continuous
    Units: years
        median (full range (min-max))
    40.0 (18.0 to 55.0) 40.5 (22.0 to 55.0) -
    Weight - 1
    Units: kg
        arithmetic mean (standard deviation)
    75.0 ± 12.20 73.8 ± 12.83 -
    Weight - 2
    Units: kg
        median (full range (min-max))
    73.4 (52.3 to 106.8) 72.1 (49.7 to 122.0) -
    BMI - 1
    Units: kg/m2
        arithmetic mean (standard deviation)
    24.29 ± 2.919 24.37 ± 3.218 -
    BMI - 2
    Units: kg/m2
        median (full range (min-max))
    24.61 (19.07 to 30.54) 23.81 (18.66 to 30.96) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Subjects randomized to and receiving placebo

    Reporting group title
    BRIS10 M2SR
    Reporting group description
    Subjects randomized to and receiving BRIS10 M2SR

    Primary: Summary of qRT-PCR Viral Load Following Challenge (FAS) - AUC - 1

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    End point title
    Summary of qRT-PCR Viral Load Following Challenge (FAS) - AUC - 1 [1]
    End point description
    Primary endpoint 1: Area under the curve (AUC) of the influenza RNA log10 viral load by qRT-PCR from nasopharyngeal swabs of study subjects in the vaccine and placebo groups.
    End point type
    Primary
    End point timeframe
    From the time of challenge inoculation with A/Belgium/4217/2015 until discharge (10 days after inoculation).
    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: There were no pre-specified tests of hypotheses. Analyses were descriptive summaries of results.
    End point values
    Placebo BRIS10 M2SR
    Number of subjects analysed
    51
    48
    Units: n, n Missing
        AUC (n)
    51
    48
        AUC (n Missing)
    0
    0
        ln(AUC) (n)
    51
    48
        ln(AUC) (n Missing)
    0
    0
    No statistical analyses for this end point

    Primary: Summary of qRT-PCR Viral Load Following Challenge (FAS) - AUC - 2

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    End point title
    Summary of qRT-PCR Viral Load Following Challenge (FAS) - AUC - 2 [2]
    End point description
    Primary endpoint 1: Area under the curve (AUC) of the influenza RNA log10 viral load by qRT-PCR from nasopharyngeal swabs of study subjects in the vaccine and placebo groups.
    End point type
    Primary
    End point timeframe
    From the time of challenge inoculation with A/Belgium/4217/2015 until discharge (10 days after inoculation).
    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: There were no pre-specified tests of hypotheses. Analyses were descriptive summaries of results.
    End point values
    Placebo BRIS10 M2SR
    Number of subjects analysed
    51
    48
    Units: Viral load
    arithmetic mean (standard deviation)
        AUC
    513.85 ± 444.798
    423.99 ± 420.644
        ln(AUC)
    5.11 ± 2.348
    4.78 ± 2.296
    No statistical analyses for this end point

    Primary: Summary of qRT-PCR Viral Load Following Challenge (FAS) - AUC - 3

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    End point title
    Summary of qRT-PCR Viral Load Following Challenge (FAS) - AUC - 3 [3]
    End point description
    Primary endpoint 1: Area under the curve (AUC) of the influenza RNA log10 viral load by qRT-PCR from nasopharyngeal swabs of study subjects in the vaccine and placebo groups.
    End point type
    Primary
    End point timeframe
    From the time of challenge inoculation with A/Belgium/4217/2015 until discharge (10 days after inoculation).
    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: There were no pre-specified tests of hypotheses. Analyses were descriptive summaries of results.
    End point values
    Placebo BRIS10 M2SR
    Number of subjects analysed
    51
    48
    Units: Viral load
    median (full range (min-max))
        AUC
    501.33 (0.00 to 1404.25)
    303.23 (0.00 to 1216.12)
        ln(AUC)
    6.22 (0.00 to 7.25)
    5.71 (0.00 to 7.10)
    No statistical analyses for this end point

    Primary: Overall Summary of Adverse Events – Vaccine Period (Safety Set) - 1

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    End point title
    Overall Summary of Adverse Events – Vaccine Period (Safety Set) - 1 [4]
    End point description
    Primary endpoint 2: Number of study subjects reporting solicited and unsolicited adverse events (AEs) and serious adverse events (SAEs)
    End point type
    Primary
    End point timeframe
    From the time of administration of the vaccine or placebo until administration of challenge virus.
    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: There were no pre-specified tests of hypotheses. Analyses were descriptive summaries of results.
    End point values
    Placebo BRIS10 M2SR
    Number of subjects analysed
    56
    52
    Units: Number of subjects
        # Subjects with at least 1 TEAE
    34
    32
        # Subjects with at least 1 TEAE related to vaccine
    28
    21
    No statistical analyses for this end point

    Primary: Overall Summary of Adverse Events – Vaccine Period (Safety Set) - 2

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    End point title
    Overall Summary of Adverse Events – Vaccine Period (Safety Set) - 2 [5]
    End point description
    Primary endpoint 2: Proportions of study subjects reporting solicited and unsolicited adverse events (AEs) and serious adverse events (SAEs).
    End point type
    Primary
    End point timeframe
    From the time of administration of the vaccine or placebo until administration of challenge virus.
    Notes
    [5] - 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: There were no pre-specified tests of hypotheses. Analyses were descriptive summaries of results.
    End point values
    Placebo BRIS10 M2SR
    Number of subjects analysed
    56
    52
    Units: % of Subjects
        % Subjects with at least 1 TEAE
    61
    62
        % Subjects with at least 1 TEAE related to vaccine
    50
    40
    No statistical analyses for this end point

    Secondary: Summary of Overall Infection and Influenza Illness (Full Analysis Set)

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    End point title
    Summary of Overall Infection and Influenza Illness (Full Analysis Set)
    End point description
    Secondary endpoint: the proportion of study subjects in vaccine and placebo groups with infection following challenge with A/Belgium/4217/2015 as determined by qRT-PCR.2 and the proportion of study subjects in vaccine and placebo groups with infection AND influenza illness following intranasal challenge with A/Belgium/4217/2015. - Infection is defined as at least two consecutive qRT-PCR positive swabs starting on the second day after challenge (Day 3). - Influenza illness is defined as either at least one respiratory symptom on two consecutive days OR at least one respiratory and at least one systemic symptom on two consecutive days.
    End point type
    Secondary
    End point timeframe
    During the trial
    End point values
    Placebo BRIS10 M2SR
    Number of subjects analysed
    51
    48
    Units: Number of Subjects
        Infected
    36
    26
        Influenza illness
    29
    23
        Infected and Influenza illness
    25
    16
    Statistical analysis title
    Proportion of subjects infected
    Comparison groups
    Placebo v BRIS10 M2SR
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    other [6]
    P-value
    = 0.10133
    Method
    Fisher exact
    Confidence interval
    Notes
    [6] - Descriptive
    Statistical analysis title
    Proportion of subjects with Influenza illness
    Comparison groups
    Placebo v BRIS10 M2SR
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    other [7]
    P-value
    = 0.42383
    Method
    Fisher exact
    Confidence interval
    Notes
    [7] - Descriptive
    Statistical analysis title
    Proportion of subjects infected &Influenza illness
    Comparison groups
    Placebo v BRIS10 M2SR
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    other [8]
    P-value
    = 0.15316
    Method
    Fisher exact
    Confidence interval
    Notes
    [8] - Descriptive

    Secondary: Treatment-Emergent Adverse Events (TEAE)

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    End point title
    Treatment-Emergent Adverse Events (TEAE)
    End point description
    Secondary endpoint: Number (+%) of study subjects reporting treatment-emergent solicited and unsolicited AEs and SAEs.
    End point type
    Secondary
    End point timeframe
    During the study
    End point values
    Placebo BRIS10 M2SR
    Number of subjects analysed
    56
    52
    Units: Number (+%) of subjects
        Nbr of subjects with any TEAE
    34
    32
        % of subjects with any TEAE
    61
    62
        Nbr of subjects with any vaccine related TEAE
    28
    21
        % of subjects with any vaccine related TEAE
    50
    40
    No statistical analyses for this end point

    Secondary: Challenge-Emergent Adverse Events (CEAE)

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    End point title
    Challenge-Emergent Adverse Events (CEAE)
    End point description
    Secondary endpoint: Number (+%) of study subjects reporting challenge -emergent solicited and unsolicited AEs and SAEs.
    End point type
    Secondary
    End point timeframe
    During the study
    End point values
    Placebo BRIS10 M2SR
    Number of subjects analysed
    56
    52
    Units: Number and % of subjects
        Nbr of subjects with any CEAE
    39
    36
        % of subjects with any CEAE
    76
    75
        Nbr of subjects with any innoculation related CEAE
    37
    34
        % of subjects with any innoculation related CEAE
    73
    71
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events are monitored continuously from day of IP treatment until the last study-related activity (typically Day 28)
    Adverse event reporting additional description
    At regular intervals during the study, subjects will be asked non-leading questions to determine the occurrence of any AEs. All AEs reported spontaneously during the course of the study will be recorded as well. Solicited and unsolicited signs and symptoms will be reported as AEs after review by the Investigator or designee.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Placebo - TEAE
    Reporting group description
    Subjects randomized to and receiving placebo

    Reporting group title
    BRIS10 M2SR - TEAE
    Reporting group description
    Subjects randomized to and receiving BRIS10 M2SR

    Reporting group title
    Placebo - CEAE
    Reporting group description
    -

    Reporting group title
    BRIS10 M2SR - CEAE
    Reporting group description
    -

    Serious adverse events
    Placebo - TEAE BRIS10 M2SR - TEAE Placebo - CEAE BRIS10 M2SR - CEAE
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 48 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Placebo - TEAE BRIS10 M2SR - TEAE Placebo - CEAE BRIS10 M2SR - CEAE
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    34 / 56 (60.71%)
    32 / 52 (61.54%)
    39 / 51 (76.47%)
    36 / 48 (75.00%)
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    1
    0
    0
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    6 / 56 (10.71%)
    4 / 52 (7.69%)
    0 / 51 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Malaise
         subjects affected / exposed
    2 / 56 (3.57%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Chills
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Influenza like illness
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 52 (0.00%)
    34 / 51 (66.67%)
    30 / 48 (62.50%)
         occurrences all number
    0
    0
    1
    1
    Vessel puncture site haematoma
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    1
    1
    Feeling hot
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    0
    1
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 52 (0.00%)
    4 / 51 (7.84%)
    0 / 48 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Injury, poisoning and procedural complications
    Fracture
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Arthropod bite
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Ligament sprain
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Skin wound
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 48 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Injury
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    0
    1
    Investigations
    Hepatic enzyme increased
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Nasal congestion
         subjects affected / exposed
    9 / 56 (16.07%)
    7 / 52 (13.46%)
    1 / 51 (1.96%)
    0 / 48 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    9 / 56 (16.07%)
    8 / 52 (15.38%)
    0 / 51 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Cough
         subjects affected / exposed
    4 / 56 (7.14%)
    2 / 52 (3.85%)
    0 / 51 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Throat irritation
         subjects affected / exposed
    4 / 56 (7.14%)
    6 / 52 (11.54%)
    0 / 51 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Respiratory tract irritation
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Sneezing
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    1 / 48 (2.08%)
         occurrences all number
    1
    0
    1
    1
    Epistaxis
         subjects affected / exposed
    0 / 56 (0.00%)
    2 / 52 (3.85%)
    0 / 51 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    0
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    0
    1
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    16 / 56 (28.57%)
    11 / 52 (21.15%)
    1 / 51 (1.96%)
    0 / 48 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Dysgeusia
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vertigo
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 56 (1.79%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Constipation
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Tooth disorder
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Toothache
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Vomiting
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Diarrhoea
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 48 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Abdominal discomfort
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    0
    1
    Stomatitis
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pruritus
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Rash
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    3 / 56 (5.36%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Musculoskeletal stiffness
         subjects affected / exposed
    2 / 56 (3.57%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Back pain
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    0
    1
    Pain in extremity
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    1
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 56 (3.57%)
    1 / 52 (1.92%)
    1 / 51 (1.96%)
    0 / 48 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Oral herpes
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Herpes simplex
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 48 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 48 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Fungal skin infection
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 48 (2.08%)
         occurrences all number
    0
    0
    0
    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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