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    Clinical Trial Results:
    Immunogenicity and Tolerability Study of FLUVAL AB Novo Suspension for Injection (trivalent, seasonal influenza vaccine, active ingredient content: 6 μg HA/strain/0.5 ml) for Children and Adolescents

    Summary
    EudraCT number
    		 2013-003449-40
    Trial protocol
    		 HU  
    Global end of trial date
    09 Dec 2014

    Results information
    Results version number
    		 v2(current)
    This version publication date
    25 Jun 2017
    First version publication date
    06 Jan 2017
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Correction of data set.
    Summary report(s)
    		 2013-003449-40-FSR-Synospis

    Trial information

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    Trial identification
    Sponsor protocol code
    FABNovo-H-16
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Omninvest Ltd.
    Sponsor organisation address
    Fö utca 7., Pilisborosjenö, Hungary, H-2097
    Public contact
    Clinical expert, Fluart Innovative Vaccines Ltd., 36 204197063, jeno.makra@fluart.hu
    Scientific contact
    Study director, Omninvest Ltd., 36 204197136, brigitta.kozma@omninvest.hu
    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
    25 Feb 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    09 Dec 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Dec 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Assessment immunogenicity and safety of Fluval AB Novo seasonal influenza vaccine with 3 x 6 μgHA active ingredient in two age groups (children and adolescents).
    Protection of trial subjects
    Only subjects that met all the study inclusion and none of the exclusion criteria were enrolled and vaccinated in the study. Vaccinations were performed by qualified and trained study personnel. Subjects with allergy to any of the vaccine components were not vaccinated. After vaccination, subjects were also kept under clinical observation for 30 minutes to ensure their safety. Appropriate medical equipment was also available on site in case of any immediate allergic reactions.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Oct 2013
    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
    Hungary: 120
    Worldwide total number of subjects
    120
    EEA total number of subjects
    120
    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)
    60
    Adolescents (12-17 years)
    60
    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
    		 healthy volunteers of full contractual capacity were planned to be enrolled in two age groups (3 to 11 years and 12 to 18 years) from both sexes

    Pre-assignment
    Screening details
    		 Performance of brief physical examination, including measurement of heart rate, axillary temperature, blood pressure, check of the heart, lungs, and axillary lymph nodes, etc.

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

    Arms
    Arm title
    		 Treatment
    Arm description
    		 Children 3-11 years: Sixty (60) healthy volunteers of full contractual capacity from both sexes were enrolled. Treatment: 0.5 x 6 μgHA/strain/0.5ml of Fluval AB Novo trivalent influenza vaccine was administered once at Day 0. Adolescents 12-18 years: Sixty (60) healthy volunteers of full contractual capacity from both sexes were enrolled. Treatment: 1 x 6 μgHA/strain/0.5ml of Fluval AB Novo trivalent influenza vaccine was administered once at Day 0.
    Arm type
    		 Intervention

    Investigational medicinal product name
    Fluval AB Novo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Children 3-11 years: Treatment: 0.5 x 6 μgHA/strain/0.5ml of Fluval AB Novo trivalent influenza vaccine was administered once at Day 0. Adolescents 12-18 years: Treatment: 1 x 6 μgHA/strain/0.5ml of Fluval AB Novo trivalent influenza vaccine was administered once at Day 0.

    Number of subjects in period 1
    		Treatment
    Started
    120
    Completed
    120

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 All one hundred and twenty (120) subjects entered in the study and were vaccinated (ITT population). All one hundred and twenty (120) subjects attended visit at Day 21-28, all of whom (one hundred and twenty (120) subjects) data were available and evaluated (PP population).

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 120 120
    Age categorical
    Children 3-11 years: A child is belonging to age group 3-11 years, if he/she has already been turning 3 but has not yet been turning 12 on the day of vaccination. Adolescents 12-18 years: An adolescent subject is belonging to age group 12-18 years, if he/she has already been turning 12 but has not yet been turning 18 on the day of vaccination.
    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)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 60 60
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
        Children 3-11 years
    		 60 60
    Age continuous
    Units: years
        median (full range (min-max))
    		 11 (3 to 17) -
    Gender categorical
    Units: Subjects
        Female
    		 53 53
        Male
    		 67 67

    End points

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    End points reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 Children 3-11 years: Sixty (60) healthy volunteers of full contractual capacity from both sexes were enrolled. Treatment: 0.5 x 6 μgHA/strain/0.5ml of Fluval AB Novo trivalent influenza vaccine was administered once at Day 0. Adolescents 12-18 years: Sixty (60) healthy volunteers of full contractual capacity from both sexes were enrolled. Treatment: 1 x 6 μgHA/strain/0.5ml of Fluval AB Novo trivalent influenza vaccine was administered once at Day 0.

    Primary: Geometric Mean Titers (GMTs) of influenza Antibodies Before and After Vaccination in subjects aged 3-11 years

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    End point title
    		 Geometric Mean Titers (GMTs) of influenza Antibodies Before and After Vaccination in subjects aged 3-11 years [1]
    End point description
    Anti-hemagglutinin antibody titers were measured for each strain by Hemagglutination Inhibition (HI) test. The GMTs were determined by HI titer.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21-28 (post-vaccination)
    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: Descriptive analysis was performed based on the study group and the study vaccine administered for this outcome.
    End point values
    		 Treatment
    Number of subjects analysed
    60 [2]
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        A/H1N1; Day 0
    31.8 (23.69 to 41.58)
        A/H1N1; Day 21
    136.1 (106 to 174.8)
        A/H3N2; Day 0
    92.96 (65.88 to 131.2)
        A/H3N2; Day 21
    463.1 (349.8 to 613.2)
        B/; Day 0
    17.82 (12.5 to 25.39)
        B/; Day 21
    75.95 (51.64 to 111.7)
    Notes
    [2] - PP population in Children aged 3-11 years: sixty (60) persons.
    No statistical analyses for this end point

    Primary: Percentage of Subjects Aged 3-11 years With Seroconversion Against Influenza Antigens Before and After Vaccination

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    End point title
    		 Percentage of Subjects Aged 3-11 years With Seroconversion Against Influenza Antigens Before and After Vaccination [3]
    End point description
    Anti-hemagglutinin antibody titers were measured for each strain by Hemagglutination Inhibition (HI) test. Seroconversion was defined as the proportion of subjects with a pre-vaccination titer < 10 (1/dil) to a post-vaccination titer ≥ 40 (1/dil). Significant increase was defined as proportion of subjects with a pre- vaccination titer ≥ 10 (1/dil) and ≥ 4-fold increase of the titer.
    End point type
    Primary
    End point timeframe
    Day 21 post-vaccination/Day 0 (pre-vaccination
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analysis was performed based on the study group and the study vaccine administered for this outcome.
    End point values
    		 Treatment
    Number of subjects analysed
    60 [4]
    Units: Percentage of subjects
    number (not applicable)
        A/H1N1; Day 21
    61.67
        A/H3N2; Day 21
    58.33
        B/; Day 21
    66.67
    Notes
    [4] - PP population in Children aged 3-11 years: sixty (60) persons.
    No statistical analyses for this end point

    Primary: Geometric Mean Titers (GMTs) of Influenza Antibodies Before and After Vaccination with Fluval AB Novo in subjects 12-17 years.

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    End point title
    		 Geometric Mean Titers (GMTs) of Influenza Antibodies Before and After Vaccination with Fluval AB Novo in subjects 12-17 years. [5]
    End point description
    Anti-hemagglutinin antibody titers were measured for each strain by Hemagglutination Inhibition (HI) test. The GMTs were determined by HI titer.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 post-vaccination.
    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: Descriptive analysis was performed based on the study group and the study vaccine administered for this outcome.
    End point values
    		 Treatment
    Number of subjects analysed
    60 [6]
    Units: 1/dil
    geometric mean (confidence interval 95%)
        A/H1N1; Day 0
    35.64 (26.06 to 48.74)
        A/H1N1; Day 21
    167.6 (134 to 209.5)
        A/H3N2; Day 0
    69.64 (46.4 to 104.5)
        A/H3N2; Day 21
    417.4 (317.3 to 549)
        B/; Day 0
    20.47 (15.24 to 27.49)
        B/; Day 21
    97.36 (75.4 to 125.7)
    Notes
    [6] - PP population in Children aged 12-17 years: sixty (60) persons.
    No statistical analyses for this end point

    Primary: Percentage of Subjects Aged 12 - 17 years With Seroconversion Against Influenza Antigens Before and After Vaccination

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    End point title
    		 Percentage of Subjects Aged 12 - 17 years With Seroconversion Against Influenza Antigens Before and After Vaccination [7]
    End point description
    Anti-hemagglutinin antibody titers were measured for each strain by Hemagglutination Inhibition (HI) test. Seroconversion was defined as the proportion of subjects with a pre-vaccination titer < 10 (1/dil) to a post-vaccination titer ≥ 40 (1/dil). Significant increase was defined as proportion of subjects with a pre-vaccination titer ≥ 10 (1/dil) and ≥ 4-fold increase of the titer. Seroprotection was defined as antibody titers ≥ 40 (1/dil).
    End point type
    Primary
    End point timeframe
    Day 21 post-vaccination/Day 0 (pre-vaccination)
    Notes
    [7] - 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: Descriptive analysis was performed based on the study group and the study vaccine administered for this outcome.
    End point values
    		 Treatment
    Number of subjects analysed
    60 [8]
    Units: Percentage of subjects
    number (not applicable)
        A/H1N1; Day 21
    66.67
        A/H3N2; Day 21
    61.67
        B/; Day 21
    70
    Notes
    [8] - PP population in Children aged 12-17 years: sixty (60) persons.
    No statistical analyses for this end point

    Primary: Geometric Mean Titer Ratios (GMTRs) of influenza Antibodies After Vaccination in subjects aged 3-11 years

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    End point title
    		 Geometric Mean Titer Ratios (GMTRs) of influenza Antibodies After Vaccination in subjects aged 3-11 years [9]
    End point description
    Anti-hemagglutinin antibody titers were measured for each strain by Hemagglutination Inhibition (HI) test. The GMTs were determined by HI titer.
    End point type
    Primary
    End point timeframe
    Day 21 post-vaccination/Day 0 (pre-vaccination)
    Notes
    [9] - 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: Descriptive analysis was performed based on the study group and the study vaccine administered for this outcome.
    End point values
    		 Treatment
    Number of subjects analysed
    60 [10]
    Units: Titer ratios (1/dil)
    geometric mean (confidence interval 95%)
        A/H1N1
    4.337 (3.432 to 5.48)
        A/H3N2
    4.982 (3.847 to 6.451)
        B/
    4.262 (3.383 to 5.37)
    Notes
    [10] - PP population in Children aged 3-11 years: sixty (60) persons.
    No statistical analyses for this end point

    Primary: Geometric Mean Titer Ratios (GMTRs) of influenza Antibodies After Vaccination in subjects aged 12-17 years

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    End point title
    		 Geometric Mean Titer Ratios (GMTRs) of influenza Antibodies After Vaccination in subjects aged 12-17 years [11]
    End point description
    Anti-hemagglutinin antibody titers were measured for each strain by Hemagglutination Inhibition (HI) test. The GMTs were determined by HI titer.
    End point type
    Primary
    End point timeframe
    Day 21 post-vaccination/Day 0 (pre-vaccination)
    Notes
    [11] - 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: Descriptive analysis was performed based on the study group and the study vaccine administered for this outcome.
    End point values
    		 Treatment
    Number of subjects analysed
    60 [12]
    Units: Titer ratios (1/dil)
    geometric mean (confidence interval 95%)
        A/H1N1
    4.702 (3.595 to 6.151)
        A/H3N2
    5.993 (4.207 to 8.539)
        B/
    4.757 (3.762 to 6.014)
    Notes
    [12] - PP population in Children aged 12-17 years: sixty (60) persons.
    No statistical analyses for this end point

    Primary: Percentage of Subjects Aged 3 to 11 Years With Seroprotection Against Influenza Antigens Before and After Vaccination

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    End point title
    		 Percentage of Subjects Aged 3 to 11 Years With Seroprotection Against Influenza Antigens Before and After Vaccination [13]
    End point description
    Anti-hemagglutinin antibody titers were measured for each strain by Hemagglutination Inhibition (HI) test. Seroprotection was defined as antibody titers ≥ 40 (1/dil).
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 post-vaccination
    Notes
    [13] - 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: Descriptive analysis was performed based on the study group and the study vaccine administered for this outcome.
    End point values
    		 Treatment
    Number of subjects analysed
    60 [14]
    Units: Percentage of subjects
    number (not applicable)
        A/H1N1; Day 0
    50
        A/H1N1; Day 21
    91.67
        A/H3N2; Day 0
    70
        A/H3N2; Day 21
    95
        B/; Day 0
    26.67
        B/; Day 21
    80
    Notes
    [14] - PP population in Children aged 3-11 years: sixty (60) persons.
    No statistical analyses for this end point

    Primary: Percentage of Subjects Aged 12-17 Years With Seroprotection Against Influenza Antigens Before and After Vaccination

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    End point title
    		 Percentage of Subjects Aged 12-17 Years With Seroprotection Against Influenza Antigens Before and After Vaccination [15]
    End point description
    Anti-hemagglutinin antibody titers were measured for each strain by Hemagglutination Inhibition (HI) test. Seroprotection was defined as antibody titers ≥ 40 (1/dil).
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 post-vaccination
    Notes
    [15] - 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: Descriptive analysis was performed based on the study group and the study vaccine administered for this outcome.
    End point values
    		 Treatment
    Number of subjects analysed
    60 [16]
    Units: Percentage of subjects
    number (not applicable)
        A/H1N1; Day 0
    56.67
        A/H1N1; Day 21
    96.67
        A/H3N2; Day 0
    58.33
        A/H3N2; Day 21
    95
        B/; Day 0
    40
        B/; Day 21
    86.67
    Notes
    [16] - PP population in Children aged 12-17 years: sixty (60) persons.
    No statistical analyses for this end point

    Primary: Proportion of subjects seroconverted or had a significant increase in titres in subjects aged 3-11 years

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    End point title
    		 Proportion of subjects seroconverted or had a significant increase in titres in subjects aged 3-11 years [17]
    End point description
    Criteria: number of seroconversions or significant increase in antihaemagglutinin antibody titre >40%
    End point type
    Primary
    End point timeframe
    From day 0 to Day 21-28
    Notes
    [17] - 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: Descriptive analysis was performed based on the study group and the study vaccine administered for this outcome.
    End point values
    		 Treatment
    Number of subjects analysed
    60 [18]
    Units: Percentage of subjects
    number (not applicable)
        A/H1N1
    61.67
        A/H3N2
    58.33
        B/
    66.67
    Notes
    [18] - PP population in Children aged 3-11 years: sixty (60) persons.
    No statistical analyses for this end point

    Primary: Increase in GMT in subjects aged 3-11 years

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    End point title
    		 Increase in GMT in subjects aged 3-11 years [19]
    End point description
    Criteria: mean geometric increase of antihaemagglutinin antibody titres: >2.5
    End point type
    Primary
    End point timeframe
    Day 0 to Day 21-28
    Notes
    [19] - 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: Descriptive analysis was performed based on the study group and the study vaccine administered for this outcome.
    End point values
    		 Treatment
    Number of subjects analysed
    60 [20]
    Units: unit(s)
    number (not applicable)
        A/H1N1
    4.337
        A/H3N2
    4.982
        B/
    4.262
    Notes
    [20] - PP population in Children aged 3-11 years: sixty (60) persons.
    No statistical analyses for this end point

    Primary: Proportion of subjects seroprotected in subjects aged 3-11 years

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    End point title
    		 Proportion of subjects seroprotected in subjects aged 3-11 years [21]
    End point description
    Criteria: the proportion of subjects achieving an antihaemagglutinin antibody titre ≥40 should be >70%.
    End point type
    Primary
    End point timeframe
    Day 0 to Day 21-28.
    Notes
    [21] - 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: Descriptive analysis was performed based on the study group and the study vaccine administered for this outcome.
    End point values
    		 Treatment
    Number of subjects analysed
    60 [22]
    Units: Percentage of subjects
    number (not applicable)
        A/H1N1
    91.67
        A/H3N2
    95
        B/
    80
    Notes
    [22] - PP population in Children aged 3-11 years: sixty (60) persons.
    No statistical analyses for this end point

    Primary: Proportion of subjects seroconverted or had a significant increase in titres in subjects aged 12-17 years

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    End point title
    		 Proportion of subjects seroconverted or had a significant increase in titres in subjects aged 12-17 years [23]
    End point description
    Criteria: number of seroconversions or significant increase in antihaemagglutinin antibody titre >40%
    End point type
    Primary
    End point timeframe
    Day 0 to Day21-28.
    Notes
    [23] - 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: Descriptive analysis was performed based on the study group and the study vaccine administered for this outcome.
    End point values
    		 Treatment
    Number of subjects analysed
    60 [24]
    Units: Percentage of subjects
    number (not applicable)
        A/H1N1
    66.67
        A/H3N2
    61.67
        B/
    70
    Notes
    [24] - PP population in Children aged 12-17 years: sixty (60) persons.
    No statistical analyses for this end point

    Primary: Increase in GMT in subjects aged 12-17 years

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    End point title
    		 Increase in GMT in subjects aged 12-17 years [25]
    End point description
    Criteria: mean geometric increase of antihaemagglutinin antibody titres: >2.5
    End point type
    Primary
    End point timeframe
    Day 0 to day 21-28.
    Notes
    [25] - 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: Descriptive analysis was performed based on the study group and the study vaccine administered for this outcome.
    End point values
    		 Treatment
    Number of subjects analysed
    60 [26]
    Units: unit(s)
    number (not applicable)
        A/H1N1
    4.702
        A/H3N2
    5.993
        B/
    4.757
    Notes
    [26] - PP population in Children aged 12-17 years: sixty (60) persons.
    No statistical analyses for this end point

    Primary: Proportion of subjects seroprotected in subjects aged 12-17 years

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    End point title
    		 Proportion of subjects seroprotected in subjects aged 12-17 years [27]
    End point description
    Criteria: the proportion of subjects achieving an antihaemagglutinin antibody titre ≥40 should be >70%.
    End point type
    Primary
    End point timeframe
    Day 0 to day 21-28.
    Notes
    [27] - 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: Descriptive analysis was performed based on the study group and the study vaccine administered for this outcome.
    End point values
    		 Treatment
    Number of subjects analysed
    60 [28]
    Units: Percentage of subjects
    number (not applicable)
        A/H1N1
    96.67
        A/H3N2
    95
        B/
    86.67
    Notes
    [28] - PP population in Children aged 12-17 years: sixty (60) persons.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 0 to day 21-28.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14
    Reporting groups
    Reporting group title
    Treatment group
    Reporting group description
    		 -

    Serious adverse events
    		 Treatment group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 120 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Treatment group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    50 / 120 (41.67%)
    Nervous system disorders
    Headache
    Additional description: 1 of them was not related to the study medication, according to the investigator.
         subjects affected / exposed
    5 / 120 (4.17%)
         occurrences all number
    5
    Syncope
    Additional description: All of them was not related to the study medication, according to the investigator.
         subjects affected / exposed
    3 / 120 (2.50%)
         occurrences all number
    3
    General disorders and administration site conditions
    Vaccination site pain
         subjects affected / exposed
    38 / 120 (31.67%)
         occurrences all number
    38
    Vaccination site erythema
         subjects affected / exposed
    9 / 120 (7.50%)
         occurrences all number
    9
    Vaccination site induration
         subjects affected / exposed
    8 / 120 (6.67%)
         occurrences all number
    8
    Vaccination site swelling
         subjects affected / exposed
    9 / 120 (7.50%)
         occurrences all number
    9
    Vaccination site haematoma
         subjects affected / exposed
    2 / 120 (1.67%)
         occurrences all number
    2
    Chills
    Additional description: 2 of them were not related to the study medication, according to the investigator.
         subjects affected / exposed
    3 / 120 (2.50%)
         occurrences all number
    3
    Malaise
    Additional description: 1 of them was not related to the study medication, according to the investigator.
         subjects affected / exposed
    9 / 120 (7.50%)
         occurrences all number
    9
    Pyrexia
    Additional description: 3 of them were not related to the study medication, according to the investigator.
         subjects affected / exposed
    6 / 120 (5.00%)
         occurrences all number
    6
    Immune system disorders
    Hypersensitivity
    Additional description: All of them was not related to the study medication, according to the investigator.
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Gastrointestinal disorders
    Vomiting
    Additional description: 1 of them was not related to the study medication, according to the investigator.
         subjects affected / exposed
    2 / 120 (1.67%)
         occurrences all number
    2
    Abdominal pain
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
    Additional description: All of them was not related to the study medication, according to the investigator.
         subjects affected / exposed
    2 / 120 (1.67%)
         occurrences all number
    2
    Cough
    Additional description: All of them was not related to the study medication, according to the investigator.
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    12 / 120 (10.00%)
         occurrences all number
    12
    Infections and infestations
    Nasopharyngitis
    Additional description: All of them was not related to the study medication, according to the investigator.
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Pharyngitis
    Additional description: All of them was not related to the study medication, according to the investigator.
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Cystitis
    Additional description: All of them was not related to the study medication, according to the investigator.
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1
    Helminthic infection
    Additional description: All of them was not related to the study medication, according to the investigator.
         subjects affected / exposed
    1 / 120 (0.83%)
         occurrences all number
    1

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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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