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    Clinical Trial Results:
    Immunogenicity and Safety of the Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2010-2011 Formulation (Intradermal Route)

    Summary
    EudraCT number
    2009-017688-40
    Trial protocol
    BE  
    Global end of trial date
    24 Jun 2010

    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
    GID34
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01138397
    WHO universal trial number (UTN)
    U1111-1112-2795
    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 58 50, Stephanie.pepin@sanofipasteur.com
    Scientific contact
    Director, Clinical Development, Sanofi Pasteur SA, 33 4 37 37 58 50, 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
    07 Jul 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Jun 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    In each group: 1) To evaluate compliance, in terms of immunogenicity, of the corresponding strength of the ID influenza vaccine Northern Hemisphere (NH) 2010-2011 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 2010-2011 formulation
    Protection of trial subjects
    Only subjects who 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
    02 Jun 2010
    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
    Belgium: 130
    Worldwide total number of subjects
    130
    EEA total number of subjects
    130
    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)
    78
    From 65 to 84 years
    52
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Study subjects were enrolled from 02 June 2010 to 03 June 2010 in 2 clinical centers in Belgium.

    Pre-assignment
    Screening details
    A total of 130 subjects who met all the inclusion criteria and none of the exclusion criteria were enrolled, 129 were 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; ID 9μg
    Arm description
    Adults aged 18 to 59 years who received the intradermal (ID) influenza vaccine 9μg Northern Hemisphere (NH) 2010-2011 formulation on Day 0.
    Arm type
    Experimental

    Investigational medicinal product name
    Influenza vaccine (split-virion, inactivated) for intradermal route, NH 2010-2011
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    0.1 mL dose (9μg strength), intradermal (ID) in the region of the deltoid muscle, one dose on Day 0.

    Arm title
    60 years or older; ID 15μg
    Arm description
    Adults aged 60 years or older who received the intradermal (ID) influenza vaccine 15μg Northern Hemisphere (NH) 2010-2011 formulation on Day 0.
    Arm type
    Experimental

    Investigational medicinal product name
    Influenza vaccine (split-virion, inactivated) for intradermal route, NH 2010-2011
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    0.1 mL dose (15μg strength), intradermal (ID) in the region of the deltoid muscle, one dose on Day 0.

    Number of subjects in period 1
    18 to 59 years; ID 9μg 60 years or older; ID 15μg
    Started
    65
    65
    Completed
    64
    65
    Not completed
    1
    0
         Protocol deviation
             1
             -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    18 to 59 years; ID 9μg
    Reporting group description
    Adults aged 18 to 59 years who received the intradermal (ID) influenza vaccine 9μg Northern Hemisphere (NH) 2010-2011 formulation on Day 0.

    Reporting group title
    60 years or older; ID 15μg
    Reporting group description
    Adults aged 60 years or older who received the intradermal (ID) influenza vaccine 15μg Northern Hemisphere (NH) 2010-2011 formulation on Day 0.

    Reporting group values
    18 to 59 years; ID 9μg 60 years or older; ID 15μg Total
    Number of subjects
    65 65 130
    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)
    65 13 78
        From 65-84 years
    0 52 52
        85 years and over
    0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    34.2 ± 13.2 68.8 ± 5 -
    Gender categorical
    Units: Subjects
        Female
    37 29 66
        Male
    28 36 64
    Previous seasonal influenza vaccination
    Units: Subjects
        Yes
    21 52 73
        No
    44 13 57
        Unknown
    0 0 0

    End points

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    End points reporting groups
    Reporting group title
    18 to 59 years; ID 9μg
    Reporting group description
    Adults aged 18 to 59 years who received the intradermal (ID) influenza vaccine 9μg Northern Hemisphere (NH) 2010-2011 formulation on Day 0.

    Reporting group title
    60 years or older; ID 15μg
    Reporting group description
    Adults aged 60 years or older who received the intradermal (ID) influenza vaccine 15μg Northern Hemisphere (NH) 2010-2011 formulation on Day 0.

    Primary: Geometric Mean Titers (GMTs) of Influenza Antibodies Before and After Vaccination with Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2010-2011 Formulation Administered by Intradermal Route

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    End point title
    Geometric Mean Titers (GMTs) of Influenza Antibodies Before and After Vaccination with Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2010-2011 Formulation Administered by Intradermal Route [1]
    End point description
    Immunogenicity was evaluated using the hemagglutination inhibition (HAI) method.
    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; ID 9μg 60 years or older; ID 15μg
    Number of subjects analysed
    61
    65
    Units: Titer (1/dil)
    geometric mean (confidence interval 95%)
        A/California/7/2009 (H1N1) like strain; D0
    18.5 (12.4 to 27.5)
    9.48 (7.3 to 12.3)
        A/California/7/2009 (H1N1) like strain; D21
    900 (639 to 1268)
    138 (90.4 to 210)
        A/Perth/16/2009 (H3N2) like strain; D0
    31.3 (22.4 to 43.7)
    29.8 (20.9 to 42.6)
        A/Perth/16/2009 (H3N2) like strain; D21
    1223 (907 to 1650)
    394 (275 to 564)
        Whole B/Brisbane/60/2008 like strain; D0
    13.1 (9.49 to 18.2)
    13.9 (10.7 to 18.1)
        Whole B/Brisbane/60/2008 like strain; D21
    176 (134 to 231)
    42.6 (31.3 to 58.1)
        Split B/Brisbane/60/2008 like strain; D0
    29.6 (20 to 43.9)
    47.4 (33 to 68.1)
        Split B/Brisbane/60/2008 like strain; D21
    644 (490 to 846)
    193 (143 to 259)
    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 2010-2011 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 2010-2011 Formulation Administered by Intradermal Route [2]
    End point description
    Immunogenicity was evaluated using the hemagglutination inhibition (HAI) method. Seroprotection was defined as a titer ≥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; ID 9μg 60 years or older; ID 15μg
    Number of subjects analysed
    61
    65
    Units: Percentage of subjects
    number (not applicable)
        A/California/7/2009 (H1N1) like strain; D0
    31.1
    12.3
        A/California/7/2009 (H1N1) like strain; D21
    98.4
    76.9
        A/Perth/16/2009 (H3N2) like strain; D0
    49.2
    47.7
        A/Perth/16/2009 (H3N2) like strain; D21
    100
    93.8
        Whole B/Brisbane/60/2008 like strain; D0
    24.6
    27.7
        Whole B/Brisbane/60/2008 like strain; D21
    96.7
    56.9
        Split B/Brisbane/60/2008 like strain; D0
    36.1
    58.5
        Split B/Brisbane/60/2008 like strain; D21
    98.4
    93.8
    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 2010-2011 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 2010-2011 Formulation Administered by Intradermal Route [3]
    End point description
    Immunogenicity was evaluated using the hemagglutination inhibition (HAI) method.
    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; ID 9μg 60 years or older; ID 15μg
    Number of subjects analysed
    61
    65
    Units: Percentage of subjects
    number (not applicable)
        A/California/7/2009 (H1N1) like strain; D0
    42.6
    60
        A/California/7/2009 (H1N1) like strain; D21
    0
    1.5
        A/Perth/16/2009 (H3N2) like strain; D0
    16.4
    26.2
        A/Perth/16/2009 (H3N2) like strain; D21
    0
    0
        Whole B/Brisbane/60/2008 like strain; D0
    52.5
    40
        Whole B/Brisbane/60/2008 like strain; D21
    1.6
    10.8
        Split B/Brisbane/60/2008 like strain; D0
    29.5
    15.4
        Split B/Brisbane/60/2008 like strain; D21
    0
    0
    No statistical analyses for this end point

    Primary: Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Before and After Vaccination with Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2010-2011 Formulation Administered by Intradermal Route

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    End point title
    Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Before and After Vaccination with Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2010-2011 Formulation Administered by Intradermal Route [4]
    End point description
    Immunogenicity was evaluated using the hemagglutination inhibition (HAI) method. Geometric mean of individual ratio was defined as the mean geometric increase between Day 0 and Day 21 as per the CPMP NfG.
    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; ID 9μg 60 years or older; ID 15μg
    Number of subjects analysed
    61
    65
    Units: Titer (1/dil)
    geometric mean (confidence interval 95%)
        A/California/7/2009 (H1N1) like strain
    48.7 (33.4 to 71.1)
    14.5 (9.96 to 21.2)
        A/Perth/16/2009 (H3N2) like strain
    39 (26.3 to 58)
    13.2 (8.96 to 19.5)
        Whole B/Brisbane/60/2008 like strain
    13.4 (8.87 to 20.3)
    3.06 (2.27 to 4.13)
        Split B/Brisbane/60/2008 like strain
    21.7 (14 to 33.7)
    4.06 (2.87 to 5.77)
    No statistical analyses for this end point

    Primary: Percentage of Subjects Achieving Seroconversion or Significant increase Against Influenza Antigen Before and After Vaccination with Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2010-2011 Formulation Administered by Intradermal Route

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    End point title
    Percentage of Subjects Achieving Seroconversion or Significant increase Against Influenza Antigen Before and After Vaccination with Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2010-2011 Formulation Administered by Intradermal Route [5]
    End point description
    Immunogenicity was evaluated using the hemagglutination inhibition (HAI) method. 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; ID 9μg 60 years or older; ID 15μg
    Number of subjects analysed
    61
    65
    Units: Percentage of subjects
    number (not applicable)
        A/California/7/2009 (H1N1) like strain
    93.4
    70.8
        A/Perth/16/2009 (H3N2) like strain
    95.1
    81.5
        Whole B/Brisbane/60/2008 like strain
    75.4
    26.2
        Split B/Brisbane/60/2008 like strain
    77
    43.1
    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 2010-2011 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 2010-2011 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 1 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; ID 9μg 60 years or older; ID 15μg
    Number of subjects analysed
    63
    65
    Units: Percentage of subjects
    number (not applicable)
        At least 1 reaction listed in EMEA recommendation
    20.6
    23.1
        Injection site Induration ≥5 cm for ≥ 4 days
    0
    0
        Injection site Ecchymosis
    1.6
    3.1
        Pyrexia (recorded temp. >38°C) for at least 1 day
    3.2
    1.5
        Malaise
    15.9
    20
        Shivering
    3.2
    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 2010-2011 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 2010-2011 Formulation Administered by Intradermal Route [7]
    End point description
    Solicited injection site: Pain, Pruritus, Erythema, Swelling, Induration and Ecchymosis. 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 Solicited systemic reactions: Fever - ≥39˚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; ID 9μg 60 years or older; ID 15μg
    Number of subjects analysed
    63
    65
    Units: Percentage of subjects
    number (not applicable)
        Injection site Pain
    57.1
    26.2
        Grade 3 Injection site Pain
    0
    0
        Injection site Pruritus
    34.9
    27.7
        Grade 3 Injection site Pruritus
    0
    0
        Injection site Erythema
    65.1
    50.8
        Grade 3 Injection site Erythema
    0
    0
        Injection site Swelling
    20.6
    15.4
        Grade 3 Injection site Swelling
    0
    0
        Injection site Induration
    17.5
    13.8
        Grade 3 Injection site Induration
    0
    0
        Injection site Ecchymosis
    0
    0
        Grade 3 Injection site Ecchymosis
    0
    0
        Fever
    3.2
    1.5
        Grade 3 Fever
    1.6
    0
        Headache
    25.4
    12.3
        Grade 3 Headache
    4.8
    0
        Malaise
    15.9
    20
        Grade 3 Malaise
    1.6
    0
        Myalgia
    4.8
    6.2
        Grade 3 Myalgia
    0
    0
        Shivering
    3.2
    4.6
        Grade 3 Shivering
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting Solicited Injection-site or Systemic Reaction More than 3 Days After Vaccination with Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2010-2011 Formulation Administered by Intradermal Route

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    End point title
    Percentage of Subjects Reporting Solicited Injection-site or Systemic Reaction More than 3 Days After Vaccination with Influenza Vaccine (Split Virion, Inactivated), Northern Hemisphere 2010-2011 Formulation Administered by Intradermal Route [8]
    End point description
    Solicited injection site: Pain, Pruritus, Erythema, Swelling, Induration and Ecchymosis. 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 Solicited systemic reactions: Fever - ≥39˚C; Headache, Malaise, Myalgia, and Shivering – Significant, prevents daily activity.
    End point type
    Primary
    End point timeframe
    >Day 3 post-vaccination
    Notes
    [8] - 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; ID 9μg 60 years or older; ID 15μg
    Number of subjects analysed
    63
    65
    Units: Percentage of subjects
    number (not applicable)
        Injection site Pain
    0
    0
        Grade 3 Injection site Pain
    0
    0
        Injection site Pruritus
    3.2
    0
        Grade 3 Injection site Pruritus
    0
    0
        Injection site Erythema
    1.6
    0
        Grade 3 Injection site Erythema
    0
    0
        Injection site Swelling
    0
    0
        Grade 3 Injection site Swelling
    0
    0
        Injection site Induration
    0
    0
        Grade 3 Injection site Induration
    0
    0
        Injection site Ecchymosis
    0
    0
        Grade 3 Injection site Ecchymosis
    0
    0
        Fever
    0
    0
        Grade 3 Fever
    0
    0
        Headache
    7.9
    0
        Grade 3 Headache
    0
    0
        Malaise
    3.2
    1.5
        Grade 3 Malaise
    0
    0
        Myalgia
    3.2
    0
        Grade 3 Myalgia
    0
    0
        Shivering
    3.2
    1.5
        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
    12.0
    Reporting groups
    Reporting group title
    18 to 59 years; ID 9μg
    Reporting group description
    Adults aged 18 to 59 years who received the intradermal (ID) influenza vaccine 9μg Northern Hemisphere (NH) 2010-2011 formulation on Day 0.

    Reporting group title
    60 years or older; ID 15μg
    Reporting group description
    Adults aged 60 years or older who received the intradermal (ID) influenza vaccine 15μg Northern Hemisphere (NH) 2010-2011 formulation on Day 0.

    Serious adverse events
    18 to 59 years; ID 9μg 60 years or older; ID 15μg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 63 (0.00%)
    0 / 65 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    18 to 59 years; ID 9μg 60 years or older; ID 15μg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    41 / 63 (65.08%)
    33 / 65 (50.77%)
    Nervous system disorders
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    16 / 63 (25.40%)
    8 / 65 (12.31%)
         occurrences all number
    16
    8
    General disorders and administration site conditions
    Injection site pain
    alternative assessment type: Systematic
         subjects affected / exposed
    36 / 63 (57.14%)
    17 / 65 (26.15%)
         occurrences all number
    36
    17
    Injection site erythema
    alternative assessment type: Systematic
         subjects affected / exposed
    41 / 63 (65.08%)
    33 / 65 (50.77%)
         occurrences all number
    41
    33
    Injection site swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    13 / 63 (20.63%)
    10 / 65 (15.38%)
         occurrences all number
    13
    10
    Malaise
    alternative assessment type: Systematic
         subjects affected / exposed
    10 / 63 (15.87%)
    13 / 65 (20.00%)
         occurrences all number
    10
    13
    Skin and subcutaneous tissue disorders
    Injection site induration
    alternative assessment type: Systematic
         subjects affected / exposed
    11 / 63 (17.46%)
    9 / 65 (13.85%)
         occurrences all number
    11
    9
    Musculoskeletal and connective tissue disorders
    Myalgia
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 63 (4.76%)
    4 / 65 (6.15%)
         occurrences all number
    3
    4

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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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