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    Clinical Trial Results:
    Immunogenicity and Safety of the Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2009-2010 Formulation (Intradermal Route)

    Summary
    EudraCT number
    		 2009-009977-85
    Trial protocol
    		 FR  
    Global end of trial date
    18 Jun 2009

    Results information
    Results version number
    		 v1(current)
    This version publication date
    05 Feb 2016
    First version publication date
    29 Jan 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GID29
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00945438
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur SA
    Sponsor organisation address
    2, Avenue Pont Pasteur, Lyon Cedex 07, France, F-69367
    Public contact
    Director, Clinical Development, Sanofi Pasteur SA, 33 (4) 37 37 5850, Stephanie.pepin@sanofipasteur.com
    Scientific contact
    Director, Clinical Development, Sanofi Pasteur SA, 33 (4) 37 37 5850, Stephanie.pepin@sanofipasteur.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
    08 Sep 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Jun 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    In subjects aged 18 to 59 years for the intradermal (ID) influenza vaccine 9 µg and in subjects aged 60 years or older for the ID influenza vaccine 15 µg: 1) To evaluate compliance, in terms of immunogenicity, of the corresponding strength of the ID influenza vaccine Northern Hemisphere (NH) 2009-2010 formulation with the requirements of the Committee for Proprietary Medicinal Products (CPMP) Note for Guidance (NfG) CPMP/BWP/214/96. 2) To describe the safety of the corresponding strength of the ID influenza vaccine, NH 2009-2010 formulation.
    Protection of trial subjects
    Only subjects that met all the study inclusion and none of the exclusion criteria were 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
    		 Not applicable
    Evidence for comparator
    		 Not applicable
    Actual start date of recruitment
    28 May 2009
    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
    France: 131
    Worldwide total number of subjects
    131
    EEA total number of subjects
    131
    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)
    80
    From 65 to 84 years
    51
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study subjects were enrolled on 28 May 2009 in 4 clinical centers in France.

    Pre-assignment
    Screening details
    		 A total of 131 subjects who met all inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 18 to 59 years 9 μg
    Arm description
    		 Subjects aged 18 to 59 years who were vaccinated on Day 0 with the intradermal (ID) influenza vaccine 9 μg, NH 2009-2010 formulation.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ID influenza vaccine (split virion, inactivated), NH 2009-2010 formulation
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    0.1 mL (9 μg strength), intradermal in the region of the deltoid muscle, one dose on Day 0.

    Arm title
    		 60 years or older 15 μg
    Arm description
    		 Subjects aged 60 years or older who were vaccinated on Day 0 with the intradermal (ID) influenza vaccine 15 μg, NH 2009-2010 formulation.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ID influenza vaccine (split virion, inactivated), NH 2009-2010 formulation
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    0.1 mL (15 μg strength), intradermal in the region of the deltoid muscle, one dose on Day 0.

    Number of subjects in period 1
    		18 to 59 years 9 μg 60 years or older 15 μg
    Started
    66
    65
    Completed
    65
    65
    Not completed
    1
    0
         Adverse event, non-fatal
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    18 to 59 years 9 μg
    Reporting group description
    		 Subjects aged 18 to 59 years who were vaccinated on Day 0 with the intradermal (ID) influenza vaccine 9 μg, NH 2009-2010 formulation.

    Reporting group title
    60 years or older 15 μg
    Reporting group description
    		 Subjects aged 60 years or older who were vaccinated on Day 0 with the intradermal (ID) influenza vaccine 15 μg, NH 2009-2010 formulation.

    Reporting group values
    		 18 to 59 years 9 μg 60 years or older 15 μg Total
    Number of subjects
    		 66 65 131
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 66 14 80
        From 65-84 years
    		 0 51 51
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 45.3 ± 11.6 72.7 ± 8.3 -
    Gender categorical
    Units: Subjects
        Female
    		 43 39 82
        Male
    		 23 26 49
    Previous influenza vaccination
    Units: Subjects
        Yes
    		 37 60 97
        No
    		 28 5 33
        Unknown
    		 1 0 1
    Previous influenza infection last winter
    Units: Subjects
        Yes
    		 13 0 13
        No
    		 53 65 118
        Unknown
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    18 to 59 years 9 μg
    Reporting group description
    		 Subjects aged 18 to 59 years who were vaccinated on Day 0 with the intradermal (ID) influenza vaccine 9 μg, NH 2009-2010 formulation.

    Reporting group title
    60 years or older 15 μg
    Reporting group description
    		 Subjects aged 60 years or older who were vaccinated on Day 0 with the intradermal (ID) influenza vaccine 15 μg, NH 2009-2010 formulation.

    Primary: Summary of Geometric Mean Titers (GMTs) of Influenza Antibodies Before and After Vaccination with Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2009-2010 Formulation Administered by Intradermal Route

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    End point title
    		 Summary of Geometric Mean Titers (GMTs) of Influenza Antibodies Before and After Vaccination with Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2009-2010 Formulation Administered by Intradermal Route [1]
    End point description
    Influenza vaccine antibodies were assessed using the hemagglutination inhibition (HAI) technique.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 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 analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 18 to 59 years 9 μg 60 years or older 15 μg
    Number of subjects analysed
    64
    64
    Units: Titers
    geometric mean (confidence interval 95%)
        Strain A/Brisbane/59/2007 (H1N1) like; Day 0
    16 (11.7 to 21.9)
    26.2 (19.9 to 34.6)
        Strain A/Brisbane/10/2007 (H3N2) like; Day 0
    19.7 (14.4 to 26.9)
    45.3 (30.4 to 67.6)
        Strain B/Brisbane/60/2008 like; Day 0
    8.32 (7.07 to 9.79)
    11.1 (8.94 to 13.7)
        Strain A/Brisbane/59/2007 (H1N1) like; Day 21
    127 (92.1 to 174)
    62 (48.6 to 79.1)
        Strain A/Brisbane/10/2007 (H3N2) like; Day 21
    199 (139 to 284)
    119 (82.7 to 171)
        Strain B/Brisbane/60/2008 like; Day 21
    30.2 (22.8 to 39.9)
    19.8 (15.8 to 24.7)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Seroprotection Against Influenza Antigens Before and After Vaccination with Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2009-2010 Formulation Administered by Intradermal Route

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    End point title
    		 Percentage of Subjects With Seroprotection Against Influenza Antigens Before and After Vaccination with Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2009-2010 Formulation Administered by Intradermal Route [2]
    End point description
    Influenza vaccine antibodies were assessed using the hemagglutination Inhibition (HAI) technique. Seroprotection was defined as antibody titers ≥40 (1/dilution [1/dil]) on Day 0 and Day 21.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 post-vaccination
    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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 18 to 59 years 9 μg 60 years or older 15 μg
    Number of subjects analysed
    64
    64
    Units: Percentage of subjects
    number (not applicable)
        Strain A/Brisbane/59/2007 (H1N1) like; Day 0
    29.7
    42.2
        Strain A/Brisbane/10/2007 (H3N2) like; Day 0
    31.3
    51.6
        Strain B/Brisbane/60/2008 like; Day 0
    3.1
    12.5
        Strain A/Brisbane/59/2007 (H1N1) like; Day 21
    89.1
    71.9
        Strain A/Brisbane/10/2007 (H3N2) like; Day 21
    87.5
    79.7
        Strain B/Brisbane/60/2008 like; Day 21
    40.6
    25
    No statistical analyses for this end point

    Primary: Percentage of Subjects With Influenza Antibodies Titers < 10 (1/dil) Before and After Vaccination with Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2009-2010 Formulation Administered by Intradermal Route

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    End point title
    		 Percentage of Subjects With Influenza Antibodies Titers < 10 (1/dil) Before and After Vaccination with Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2009-2010 Formulation Administered by Intradermal Route [3]
    End point description
    Influenza vaccine antibodies were assessed using the hemagglutination inhibition (HAI) technique.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 post-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 analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 18 to 59 years 9 μg 60 years or older 15 μg
    Number of subjects analysed
    64
    64
    Units: Percentage of subjects
    number (not applicable)
        Strain A/Brisbane/59/2007 (H1N1) like; Day 0
    42.2
    15.6
        Strain A/Brisbane/10/2007 (H3N2) like; Day 0
    34.4
    18.8
        Strain B/Brisbane/60/2008 like; Day 0
    68.8
    56.3
        Strain A/Brisbane/59/2007 (H1N1) like; Day 21
    3.1
    0
        Strain A/Brisbane/10/2007 (H3N2) like; Day 21
    1.6
    1.6
        Strain B/Brisbane/60/2008 like; Day 21
    14.1
    20.3
    No statistical analyses for this end point

    Primary: Summary of Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Before and After Vaccination with Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2009-2010 Formulation Administered by Intradermal Route

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    End point title
    		 Summary of Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Before and After Vaccination with Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2009-2010 Formulation Administered by Intradermal Route [4]
    End point description
    Influenza vaccine antibodies were assessed using the hemagglutination inhibition (HAI) technique. Geometric mean of individual ratio was defined as the mean geometric increase between Day 0 and Day 21.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 post-vaccination
    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: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 18 to 59 years 9 μg 60 years or older 15 μg
    Number of subjects analysed
    64
    64
    Units: Titer ratios
    geometric mean (confidence interval 95%)
        Strain A/Brisbane/59/2007 (H1N1) like
    7.91 (5.59 to 11.2)
    2.37 (1.8 to 3.11)
        Strain A/Brisbane/10/2007 (H3N2) like
    10.1 (6.82 to 14.9)
    2.62 (1.99 to 3.45)
        Strain B/Brisbane/60/2008 like
    3.63 (2.74 to 4.8)
    1.79 (1.47 to 2.16)
    No statistical analyses for this end point

    Primary: Percentage of Subjects Achieving Seroconversion or Significant Increase Against Influenza Antigen After Vaccination with Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2009-2010 Formulation Administered by Intradermal Route

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    End point title
    		 Percentage of Subjects Achieving Seroconversion or Significant Increase Against Influenza Antigen After Vaccination with Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2009-2010 Formulation Administered by Intradermal Route [5]
    End point description
    Influenza vaccine antibodies were assessed using the hemagglutination inhibition (HAI) technique. Seroconversion was defined as subjects with a titer <10 (1/dil) on Day 0: post-injection titer ≥40 (1/dil) on Day 21 or significant increase for subjects with a titer ≥10 (1/dil) on Day 0: ≥4-fold increase of post-injection titer on Day 21.
    End point type
    Primary
    End point timeframe
    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 analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 18 to 59 years 9 μg 60 years or older 15 μg
    Number of subjects analysed
    64
    64
    Units: Percentage of subjects
    number (not applicable)
        Strain A/Brisbane/59/2007 (H1N1) like
    65.6
    17.2
        Strain A/Brisbane/10/2007 (H3N2) like
    67.2
    25
        Strain B/Brisbane/60/2008 like
    34.4
    4.7
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting Solicited Reactions Listed in the CPMP Note for Guidance Within 3 Days After Vaccination with Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2009-2010 Formulation Administered by Intradermal Route

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    End point title
    		 Percentage of Subjects Reporting Solicited Reactions Listed in the CPMP Note for Guidance Within 3 Days After Vaccination with Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2009-2010 Formulation Administered by Intradermal Route [6]
    End point description
    Solicited injection site reactions: Injection site induration ≥5 cm for at least 4 consecutive days and Injection site ecchymosis. Solicited systemic reactions: Pyrexia (recorded temperature > 38°C) for at least one day, Malaise, and Shivering.
    End point type
    Primary
    End point timeframe
    Day 0 up to Day 3 post-vaccination
    Notes
    [6] - 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 analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 18 to 59 years 9 μg 60 years or older 15 μg
    Number of subjects analysed
    65
    65
    Units: Percentage of subjects
    number (not applicable)
        At least 1 reaction listed in CPMP recommendation
    7.7
    4.6
        Injection site induration ≥5 cm for 4 days
    0
    0
        Injection site ecchymosis
    1.5
    0
        Pyrexia (recorded temperature > 38°C) for 1 day
    0
    0
        Malaise
    3.1
    1.5
        Shivering
    6.2
    4.6
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting Solicited Injection-site or Systemic Reaction Within 3 Days After Vaccination with Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2009-2010 Formulation Administered by Intradermal Route

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    End point title
    		 Percentage of Subjects Reporting Solicited Injection-site or Systemic Reaction Within 3 Days After Vaccination with Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2009-2010 Formulation Administered by Intradermal Route [7]
    End point description
    Solicited injection site reactions: Pain, Erythema, Swelling, Induration, Ecchymosis, and Pruritus. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3 Solicited injection site reactions: Pain and Pruritus – Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis - >10 cm. Grade 3 systemic reactions: Fever - ≥39.0˚C; Headache, Malaise, Myalgia, and Shivering – Significant, prevents daily activity.
    End point type
    Primary
    End point timeframe
    Day 0 up to Day 3 post-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 analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 18 to 59 years 9 μg 60 years or older 15 μg
    Number of subjects analysed
    65
    65
    Units: Percentage of subjects
    number (not applicable)
        Injection site Pain
    55.4
    16.9
        Grade 3 Injection site Pain
    0
    0
        Injection site Erythema
    40
    32.3
        Grade 3 Injection site Erythema
    0
    0
        Injection site Swelling
    10.8
    6.2
        Grade 3 Injection site Swelling
    0
    0
        Injection site Induration
    10.8
    3.1
        Grade 3 Injection site Induration
    0
    0
        Injection site Ecchymosis
    0
    0
        Grade 3 Injection site Ecchymosis
    0
    0
        Injection site Pruritus
    32.3
    24.6
        Grade 3 Injection site Pruritus
    0
    0
        Fever
    0
    0
        Grade 3 Fever
    0
    0
        Headache
    7.7
    7.7
        Grade 3 Headache
    0
    0
        Malaise
    3.1
    1.5
        Grade 3 Malaise
    0
    0
        Myalgia
    12.3
    7.7
        Grade 3 Myalgia
    0
    0
        Shivering
    6.2
    4.6
        Grade 3 Shivering
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 post-vaccination.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.0
    Reporting groups
    Reporting group title
    18 to 59 years 9 μg
    Reporting group description
    		 Subjects aged 18 to 59 years who were vaccinated on Day 0 with the intradermal (ID) influenza vaccine 9 μg, NH 2009-2010 formulation.

    Reporting group title
    60 years or older 15 μg
    Reporting group description
    		 Subjects aged 60 years or older who were vaccinated on Day 0 with the intradermal (ID) influenza vaccine 15 μg, NH 2009-2010 formulation.

    Serious adverse events
    		 18 to 59 years 9 μg 60 years or older 15 μg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 65 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Psychiatric disorders
    Schizophrenia
         subjects affected / exposed
    1 / 65 (1.54%)
    0 / 65 (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
    		 18 to 59 years 9 μg 60 years or older 15 μg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    36 / 65 (55.38%)
    21 / 65 (32.31%)
    Nervous system disorders
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    5 / 65 (7.69%)
    5 / 65 (7.69%)
         occurrences all number
    5
    5
    General disorders and administration site conditions
    Injection site pain
    alternative assessment type: Systematic
         subjects affected / exposed
    36 / 65 (55.38%)
    11 / 65 (16.92%)
         occurrences all number
    36
    11
    Injection site erythema
    alternative assessment type: Systematic
         subjects affected / exposed
    26 / 65 (40.00%)
    21 / 65 (32.31%)
         occurrences all number
    26
    21
    Injection site swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    7 / 65 (10.77%)
    4 / 65 (6.15%)
         occurrences all number
    7
    4
    Shivering
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 65 (6.15%)
    3 / 65 (4.62%)
         occurrences all number
    4
    3
    Skin and subcutaneous tissue disorders
    Injection site pruritus
    alternative assessment type: Systematic
         subjects affected / exposed
    21 / 65 (32.31%)
    16 / 65 (24.62%)
         occurrences all number
    21
    16
    Injection site induration
    alternative assessment type: Systematic
         subjects affected / exposed
    7 / 65 (10.77%)
    2 / 65 (3.08%)
         occurrences all number
    7
    2
    Musculoskeletal and connective tissue disorders
    Myalgia
    alternative assessment type: Systematic
         subjects affected / exposed
    8 / 65 (12.31%)
    5 / 65 (7.69%)
         occurrences all number
    8
    5

    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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    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.

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