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

    Summary
    EudraCT number
    2009-017690-38
    Trial protocol
    FR  
    Global end of trial date
    27 May 2010

    Results information
    Results version number
    v1(current)
    This version publication date
    16 Feb 2016
    First version publication date
    03 Dec 2014
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GRT90
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01121822
    WHO universal trial number (UTN)
    U1111-1112-8285
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur SA
    Sponsor organisation address
    1541, Avenue Marcel Mérieux, Marcy L’Etoile, France, 69280
    Public contact
    Director, Clinical Development, Sanofi Pasteur SA, 33 (0)4 37 37 53 50, diane.vandervliet@sanofipasteur.com
    Scientific contact
    Director, Clinical Development, Sanofi Pasteur SA, 33 (0)4 37 37 53 50, diane.vandervliet@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
    21 Jun 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 May 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1) To evaluate the compliance, in terms of immunogenicity, of the influenza vaccine (split virion, inactivated) 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 in both age groups 2) To describe the safety of the influenza vaccine (split virion, inactivated) NH 2010-2011 formulation in both age groups
    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 were also available on site in case of any immediate allergic reactions.
    Background therapy
    Not applcable
    Evidence for comparator
    Not applicable
    Actual start date of recruitment
    05 May 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
    France: 129
    Worldwide total number of subjects
    129
    EEA total number of subjects
    129
    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)
    99
    From 65 to 84 years
    30
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Study subjects were enrolled from 05 May 2010 to 27 May 2010 in 3 clinical centers in France.

    Pre-assignment
    Screening details
    A total of 129 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 60 years
    Arm description
    Subjects aged 18 to 60 years who received one dose of inactivated, split-virion influenza vaccine, Northern Hemisphere 2010-2011 formulation on day 0.
    Arm type
    Experimental

    Investigational medicinal product name
    Influenza vaccine (split virion, inactivated)
    Investigational medicinal product code
    314
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular into the deltoid muscle, one dose at Day 0.

    Arm title
    61 years or older
    Arm description
    Subjects aged 61 years or older who received one dose of inactivated, split-virion influenza vaccine, Northern Hemisphere 2010-2011 formulation on day 0.
    Arm type
    Experimental

    Investigational medicinal product name
    Influenza vaccine (split virion, inactivated)
    Investigational medicinal product code
    314
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL, intramuscular into the deltoid muscle, one dose at Day 0.

    Number of subjects in period 1
    18 to 60 years 61 years or older
    Started
    64
    65
    Completed
    63
    64
    Not completed
    1
    1
         Protocol deviation
             1
             -
         Adverse event, non-fatal
             -
             1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    18 to 60 years
    Reporting group description
    Subjects aged 18 to 60 years who received one dose of inactivated, split-virion influenza vaccine, Northern Hemisphere 2010-2011 formulation on day 0.

    Reporting group title
    61 years or older
    Reporting group description
    Subjects aged 61 years or older who received one dose of inactivated, split-virion influenza vaccine, Northern Hemisphere 2010-2011 formulation on day 0.

    Reporting group values
    18 to 60 years 61 years or older Total
    Number of subjects
    64 65 129
    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)
    64 35 99
        From 65-84 years
    0 30 30
        85 years and over
    0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    37.6 ± 14.3 66.7 ± 5.3 -
    Gender categorical
    Units: Subjects
        Female
    30 38 68
        Male
    34 27 61
    Previous seasonal influenza vaccination
    Units: Subjects
        Yes
    11 27 38
        No
    53 38 91

    End points

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    End points reporting groups
    Reporting group title
    18 to 60 years
    Reporting group description
    Subjects aged 18 to 60 years who received one dose of inactivated, split-virion influenza vaccine, Northern Hemisphere 2010-2011 formulation on day 0.

    Reporting group title
    61 years or older
    Reporting group description
    Subjects aged 61 years or older who received one dose of inactivated, split-virion influenza vaccine, Northern Hemisphere 2010-2011 formulation on day 0.

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

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    End point title
    Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies Before and After Vaccination with Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2010-2011 Formulation by the Intramuscular Route [1]
    End point description
    Influenza vaccine antibodies were assessed using the hemagglutination inhibition 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 60 years 61 years or older
    Number of subjects analysed
    64
    64
    Units: Titers
    geometric mean (confidence interval 95%)
        A/California/7/2009 (H1N1) like Strain (Day 0)
    14.3 (9.57 to 21.4)
    8.64 (6.92 to 10.8)
        A/Perth/16/2009(H3N2) like Strain (Day 0)
    16.9 (11.8 to 24.3)
    14.8 (10.7 to 20.3)
        Whole B/Brisbane/60/2008 like Strain (Day 0)
    11.6 (9.09 to 14.9)
    10.3 (7.9 to 13.4)
        Split B/Brisbane/60/2008 like Strain (Day 0)
    27.5 (19.6 to 38.7)
    26.2 (18.3 to 37.6)
        A/California/7/2009 (H1N1) like Strain (Day 21)
    385 (261 to 568)
    199 (125 to 315)
        A/Perth/16/2009(H3N2) like Strain (Day 21)
    504 (367 to 693)
    368 (246 to 552)
        Whole B/Brisbane/60/2008 like Strain (Day 21)
    157 (120 to 206)
    51.9 (37.6 to 71.6)
        Split B/Brisbane/60/2008 like Strain (Day 21)
    626 (477 to 822)
    225 (167 to 304)
    No statistical analyses for this end point

    Primary: Geometric Mean Titers Ratios (GMTR) of Influenza Vaccine Antibodies After Vaccination with Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2010-2011 Formulation by the Intramuscular Route

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    End point title
    Geometric Mean Titers Ratios (GMTR) of Influenza Vaccine Antibodies After Vaccination with Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2010-2011 Formulation by the Intramuscular Route [2]
    End point description
    Influenza vaccine antibodies were assessed using the hemagglutination inhibition technique. Geometric mean titer ratio is the geometric mean of the individual post-vaccination/pre-vaccination titer of antibodies to the influenza virus antigens.
    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 60 years 61 years or older
    Number of subjects analysed
    64
    64
    Units: Titer Ratios
    geometric mean (confidence interval 95%)
        A/California/7/2009 (H1N1) like Strain
    26.9 (17.5 to 41.4)
    23 (14.9 to 35.4)
        A/Perth/16/2009(H3N2) like Strain
    29.8 (20.5 to 43.3)
    24.9 (16.7 to 37.4)
        Whole B/Brisbane/60/2008 like Strain
    13.5 (9.4 to 19.5)
    5.05 (3.47 to 7.34)
        Split B/Brisbane/60/2008 like Strain
    22.8 (15.3 to 33.8)
    8.58 (5.59 to 13.2)
    No statistical analyses for this end point

    Primary: Percentage of Subjects Achieving a Titer of < 10 (1/dil) Against the Influenza Vaccine Antigens Before and After Vaccination with Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2010-2011 Formulation by the Intramuscular Route

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    End point title
    Percentage of Subjects Achieving a Titer of < 10 (1/dil) Against the Influenza Vaccine Antigens Before and After Vaccination with Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2010-2011 Formulation by the Intramuscular Route [3]
    End point description
    Influenza vaccine antibodies were assessed using the hemagglutination inhibition 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 60 years 61 years or older
    Number of subjects analysed
    64
    64
    Units: Percentage of subjects
    number (not applicable)
        A/California/7/2009 (H1N1) like Strain (Day 0)
    60.9
    65.6
        A/Perth/16/2009(H3N2) like Strain (Day 0)
    39.1
    42.2
        Whole B/Brisbane/60/2008 like Strain (Day 0)
    48.4
    59.4
        Split B/Brisbane/60/2008 like Strain (Day 0)
    28.1
    29.7
        A/California/7/2009 (H1N1) like Strain (Day 21)
    0
    3.1
        A/Perth/16/2009(H3N2) like Strain (Day 21)
    0
    1.6
        Whole B/Brisbane/60/2008 like Strain (Day 21)
    0
    6.3
        Split B/Brisbane/60/2008 like Strain (Day 21)
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Seroprotection Against the Influenza Vaccine Antigens Before and After Vaccination with Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2010-2011 Formulation by the Intramuscular Route

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    End point title
    Percentage of Subjects with Seroprotection Against the Influenza Vaccine Antigens Before and After Vaccination with Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2010-2011 Formulation by the Intramuscular Route [4]
    End point description
    Influenza vaccine antibodies were assessed using the hemagglutination inhibition technique. Seroprotection was defined as titers ≥40 (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
    [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 60 years 61 years or older
    Number of subjects analysed
    64
    64
    Units: Percentage of subjects
    number (not applicable)
        A/California/7/2009 (H1N1) like Strain (Day 0)
    26.6
    9.4
        A/Perth/16/2009(H3N2) like Strain (Day 0)
    21.09
    20.3
        Whole B/Brisbane/60/2008 like Strain (Day 0)
    20.3
    15.6
        Split B/Brisbane/60/2008 like Strain (Day 0)
    51.6
    45.3
        A/California/7/2009 (H1N1) like Strain (Day 21)
    92.2
    81.3
        A/Perth/16/2009(H3N2) like Strain (Day 21)
    100
    93.8
        Whole B/Brisbane/60/2008 like Strain (Day 21)
    95.3
    64.1
        Split B/Brisbane/60/2008 like Strain (Day 21)
    100
    93.8
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Seroconversion or Significant Increase Against the Influenza Vaccine Antigens Before and After Vaccination with Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2010-2011 Formulation by Intramuscular Route

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    End point title
    Percentage of Subjects with Seroconversion or Significant Increase Against the Influenza Vaccine Antigens Before and After Vaccination with Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2010-2011 Formulation by Intramuscular Route [5]
    End point description
    Influenza vaccine antibodies were assessed using the hemagglutination inhibition technique. Seroconversion was defined as subjects with a titer <10 (1/dil) on Day 0 and a post-injection titer ≥40 (1/dil) on Day 21 or significant increase was defined as subjects with a titer ≥10 (1/dil) on Day 0 and a ≥4-fold increase from pre- to 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 60 years 61 years or older
    Number of subjects analysed
    64
    64
    Units: Percentage of subjects
    number (not applicable)
        A/California/7/2009 (H1N1) like Strain
    78.1
    79.7
        A/Perth/16/2009(H3N2) like Strain
    89.1
    84.4
        Whole B/Brisbane/60/2008 like Strain
    78.1
    45.3
        Split B/Brisbane/60/2008 like Strain
    87.5
    59.4
    No statistical analyses for this end point

    Primary: Percentage of Subjects with at Least One Reaction Corresponding to those Listed in the EMEA Note for Guidance Within 3 Days After Vaccination with Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2010-2011 Formulation (Intramuscular Route)

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    End point title
    Percentage of Subjects with at Least One Reaction Corresponding to those Listed in the EMEA Note for Guidance Within 3 Days After Vaccination with Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2010-2011 Formulation (Intramuscular Route) [6]
    End point description
    Solicited injection site: Induration and Ecchymosis. Solicited systemic reactions: Pyrexia, 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 60 years 61 years or older
    Number of subjects analysed
    64
    65
    Units: Percentage of subjects
    number (not applicable)
        Injection site induration ≥5 cm for 4 days
    0
    0
        Injection site ecchymosis
    6.3
    0
        Pyrexia (>38°C for at least 1 day)
    3.1
    1.5
        Malaise
    7.8
    6.2
        Shivering
    9.4
    1.5
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting Solicited Injection-site or Systemic Reactions within 3 Days After Vaccination with Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2010-2011 Formulation by the Intramuscular Route

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    End point title
    Percentage of Subjects Reporting Solicited Injection-site or Systemic Reactions within 3 Days After Vaccination with Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2010-2011 Formulation by the Intramuscular Route [7]
    End point description
    Solicited injection site: Pain, Erythema, Swelling, Induration and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3 injection site: Pain – 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 60 years 61 years or older
    Number of subjects analysed
    64
    65
    Units: Percentage of subjects
    number (not applicable)
        Injection site Pain
    53.1
    20
        Grade 3 Injection site Pain
    0
    0
        Injection site Erythema
    1.6
    1.5
        Grade 3 Injection site Erythema
    0
    0
        Injection site Swelling
    1.6
    1.5
        Grade 3 Injection site Swelling
    0
    0
        Injection site Induration
    4.7
    0
        Grade 3 Injection site Induration
    0
    0
        Injection site Ecchymosis
    0
    0
        Grade 3 Injection site Ecchymosis
    0
    0
        Fever
    3.1
    1.5
        Grade 3 Fever
    0
    0
        Headache
    23.4
    9.2
        Grade 3 Headache
    1.6
    0
        Malaise
    7.8
    6.2
        Grade 3 Malaise
    0
    0
        Myalgia
    25
    10.8
        Grade 3 Myalgia
    0
    0
        Shivering
    9.4
    1.5
        Grade 3 Shivering
    0
    0
    No statistical analyses for this end point

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

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    End point title
    Percentage of Subjects Reporting Solicited Injection-site or Systemic Reactions More than 3 Days After Vaccination with Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2010-2011 Formulation by the Intramuscular Route [8]
    End point description
    Solicited injection site: Pain, Erythema, Swelling, Induration and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3 injection site: Pain – 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 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 60 years 61 years or older
    Number of subjects analysed
    64
    65
    Units: Percentage of subjects
    number (not applicable)
        Injection site Pain
    0
    0
        Grade 3 Injection site Pain
    0
    0
        Injection site Erythema
    0
    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
    1.5
        Grade 3 Fever
    0
    0
        Headache
    9.4
    1.5
        Grade 3 Headache
    0
    0
        Malaise
    3.1
    1.5
        Grade 3 Malaise
    0
    0
        Myalgia
    3.1
    1.5
        Grade 3 Myalgia
    0
    0
        Shivering
    1.6
    0
        Grade 3 Shivering
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of Subjects Reporting a Solicited Injection-site or Systemic Reactions Within 7 Days After Vaccination with Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2010-2011 Formulation by the Intramuscular Route

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    End point title
    Percentage of Subjects Reporting a Solicited Injection-site or Systemic Reactions Within 7 Days After Vaccination with Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2010-2011 Formulation by the Intramuscular Route [9]
    End point description
    Solicited injection site: Pain, Erythema, Swelling, Induration and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering.
    End point type
    Primary
    End point timeframe
    Day 0 up to Day 7 post-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 analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    18 to 60 years 61 years or older
    Number of subjects analysed
    64
    65
    Units: Percentage of subjects
    number (not applicable)
        Injection site Pain
    53.1
    20
        Injection site Erythema
    1.6
    1.5
        Injection site Swelling
    1.6
    1.5
        Injection site Induration
    4.7
    0
        Injection site Ecchymosis
    0
    0
        Fever
    3.1
    3.1
        Headache
    32.8
    10.8
        Malaise
    10.9
    7.7
        Myalgia
    28.1
    12.3
        Shivering
    10.9
    1.5
    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 60 years
    Reporting group description
    Subjects aged 18 to 60 years who received one dose of inactivated, split-virion influenza vaccine, Northern Hemisphere 2010-2011 formulation on day 0.

    Reporting group title
    61 years or older
    Reporting group description
    Subjects aged 61 years or older who received one dose of inactivated, split-virion influenza vaccine, Northern Hemisphere 2010-2011 formulation on day 0.

    Serious adverse events
    18 to 60 years 61 years or older
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 65 (1.54%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Renal and urinary disorders
    Left ureter lithiasis
         subjects affected / exposed
    0 / 64 (0.00%)
    1 / 65 (1.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         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 60 years 61 years or older
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    34 / 64 (53.13%)
    13 / 65 (20.00%)
    Nervous system disorders
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    21 / 64 (32.81%)
    7 / 65 (10.77%)
         occurrences all number
    21
    7
    General disorders and administration site conditions
    Injection site ecchymosis
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 64 (6.25%)
    0 / 65 (0.00%)
         occurrences all number
    4
    0
    Malaise
    alternative assessment type: Systematic
         subjects affected / exposed
    7 / 64 (10.94%)
    5 / 65 (7.69%)
         occurrences all number
    7
    5
    Shivering
    alternative assessment type: Systematic
         subjects affected / exposed
    7 / 64 (10.94%)
    1 / 65 (1.54%)
         occurrences all number
    7
    1
    Injection site pain
    alternative assessment type: Systematic
         subjects affected / exposed
    34 / 64 (53.13%)
    13 / 65 (20.00%)
         occurrences all number
    34
    13
    Musculoskeletal and connective tissue disorders
    Myalgia
    alternative assessment type: Systematic
         subjects affected / exposed
    18 / 64 (28.13%)
    8 / 65 (12.31%)
         occurrences all number
    18
    8
    Infections and infestations
    Pharyngitis
         subjects affected / exposed
    5 / 64 (7.81%)
    0 / 65 (0.00%)
         occurrences all number
    5
    0

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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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