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    Clinical Trial Results:
    Immunogenicity and Safety of Multiple Formulations of an Intramuscular Inactivated, Split Virion Swine-Origin A/H1N1 Influenza Vaccine With and Without Adjuvant in Healthy European Adult and Elderly subjects

    Summary
    EudraCT number
    2009-013344-37
    Trial protocol
    FR  
    Global end of trial date
    08 Oct 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
    GPF07
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00954798
    WHO universal trial number (UTN)
    U1111-1111-4918
    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 (0)4 37 37 58 50, stephanie.pepin@sanofipasteur.com
    Scientific contact
    Director, Clinical Development, Sanofi Pasteur SA, 33 (0)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
    24 Jan 2011
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Oct 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    •To describe the immune response of each candidate vaccine 21 days after each vaccination by hemagglutination inhibition (HAI) and seroneutralization (SN) method in all adult and elderly subjects. •To describe the safety profiles (injection site reactions, and systemic events) of each candidate vaccine during the 21 days following each vaccination, and serious adverse events throughout the study in all adult and elderly subjects.
    Protection of trial subjects
    Only subjects that met all the study inclusion and none of the exclusion criteria were randomized 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
    Not applicable
    Evidence for comparator
    Not applicable
    Actual start date of recruitment
    18 Aug 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: 450
    Worldwide total number of subjects
    450
    EEA total number of subjects
    450
    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)
    339
    From 65 to 84 years
    109
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    Study subjects were enrolled 18 August 2009 to 22 August 2009 in 12 clinical centers in France.

    Pre-assignment
    Screening details
    A total of 450 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
    3.8 μg HA+AF03; 18-60 years
    Arm description
    Subjects aged 18-60 years who received two doses of adjuvanted A/H1N1 pandemic influenza vaccine (3.8 μg HA + AF03) 21 days apart.
    Arm type
    Experimental

    Investigational medicinal product name
    Swine A/H1N1 Influenza Vaccine (split virion, inactivated, adjuvanted with AF03)
    Investigational medicinal product code
    448
    Other name
    Pharmaceutical forms
    Emulsion and suspension for emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL dose, intramuscular to be injected into the deltoid area, two doses 21 days apart.

    Arm title
    7.5 μg HA+AF03; 18-60 years
    Arm description
    Subjects aged 18-60 years who received two doses of adjuvanted A/H1N1 pandemic influenza vaccine (7.5 μg HA + AF03) 21 days apart.
    Arm type
    Experimental

    Investigational medicinal product name
    Swine A/H1N1 Influenza Vaccine (split virion, inactivated, adjuvanted with AF03)
    Investigational medicinal product code
    448
    Other name
    Pharmaceutical forms
    Emulsion and suspension for emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL dose, intramuscular to be injected into the deltoid area, two doses 21 days apart.

    Arm title
    15 μg HA; 18-60 years
    Arm description
    Subjects aged 18-60 years who received two doses of A/H1N1 pandemic influenza vaccine (15 μg HA) 21 days apart.
    Arm type
    Active comparator

    Investigational medicinal product name
    Swine A/H1N1 Influenza Vaccine (split virion, inactivated)
    Investigational medicinal product code
    448
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL dose, intramuscular to be injected into the deltoid area, two doses 21 days apart.

    Arm title
    3.8 μg HA+AF03; >60 years
    Arm description
    Subjects aged >60 years who received two doses of adjuvanted A/H1N1 pandemic influenza vaccine (3.8 μg HA + AF03) 21 days apart.
    Arm type
    Experimental

    Investigational medicinal product name
    Swine A/H1N1 Influenza Vaccine (split virion, inactivated, adjuvanted with AF03)
    Investigational medicinal product code
    448
    Other name
    Pharmaceutical forms
    Emulsion and suspension for emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL dose, intramuscular to be injected into the deltoid area, two doses 21 days apart.

    Arm title
    7.5 μg HA+AF03; >60 years
    Arm description
    Subjects aged >60 years who received two doses of adjuvanted A/H1N1 pandemic influenza vaccine (7.5 μg HA + AF03) 21 days apart.
    Arm type
    Experimental

    Investigational medicinal product name
    Swine A/H1N1 Influenza Vaccine (split virion, inactivated, adjuvanted with AF03)
    Investigational medicinal product code
    448
    Other name
    Pharmaceutical forms
    Emulsion and suspension for emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL dose, intramuscular to be injected into the deltoid area, two doses 21 days apart.

    Arm title
    15 μg HA; >60 years
    Arm description
    Subjects aged >60 years who received two doses of A/H1N1 pandemic influenza vaccine (15 μg HA) 21 days apart.
    Arm type
    Active comparator

    Investigational medicinal product name
    Swine A/H1N1 Influenza Vaccine (split virion, inactivated)
    Investigational medicinal product code
    448
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL dose, intramuscular to be injected into the deltoid area, two doses 21 days apart.

    Number of subjects in period 1
    3.8 μg HA+AF03; 18-60 years 7.5 μg HA+AF03; 18-60 years 15 μg HA; 18-60 years 3.8 μg HA+AF03; >60 years 7.5 μg HA+AF03; >60 years 15 μg HA; >60 years
    Started
    99
    100
    101
    54
    51
    45
    Completed
    98
    99
    101
    54
    50
    44
    Not completed
    1
    1
    0
    0
    1
    1
         Protocol deviation
             -
             1
             -
             -
             -
             -
         Adverse event, serious fatal
             1
             -
             -
             -
             1
             1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    3.8 μg HA+AF03; 18-60 years
    Reporting group description
    Subjects aged 18-60 years who received two doses of adjuvanted A/H1N1 pandemic influenza vaccine (3.8 μg HA + AF03) 21 days apart.

    Reporting group title
    7.5 μg HA+AF03; 18-60 years
    Reporting group description
    Subjects aged 18-60 years who received two doses of adjuvanted A/H1N1 pandemic influenza vaccine (7.5 μg HA + AF03) 21 days apart.

    Reporting group title
    15 μg HA; 18-60 years
    Reporting group description
    Subjects aged 18-60 years who received two doses of A/H1N1 pandemic influenza vaccine (15 μg HA) 21 days apart.

    Reporting group title
    3.8 μg HA+AF03; >60 years
    Reporting group description
    Subjects aged >60 years who received two doses of adjuvanted A/H1N1 pandemic influenza vaccine (3.8 μg HA + AF03) 21 days apart.

    Reporting group title
    7.5 μg HA+AF03; >60 years
    Reporting group description
    Subjects aged >60 years who received two doses of adjuvanted A/H1N1 pandemic influenza vaccine (7.5 μg HA + AF03) 21 days apart.

    Reporting group title
    15 μg HA; >60 years
    Reporting group description
    Subjects aged >60 years who received two doses of A/H1N1 pandemic influenza vaccine (15 μg HA) 21 days apart.

    Reporting group values
    3.8 μg HA+AF03; 18-60 years 7.5 μg HA+AF03; 18-60 years 15 μg HA; 18-60 years 3.8 μg HA+AF03; >60 years 7.5 μg HA+AF03; >60 years 15 μg HA; >60 years Total
    Number of subjects
    99 100 101 54 51 45 450
    Age categorical
    Units: Subjects
        In utero
    0 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0 0 0 0
        Newborns (0-27 days)
    0 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0 0 0 0
        Children (2-11 years)
    0 0 0 0 0 0 0
        Adolescents (12-17 years)
    0 0 0 0 0 0 0
        Adults (18-64 years)
    99 100 101 14 17 11 342
        From 65-84 years
    0 0 0 39 34 33 106
        85 years and over
    0 0 0 1 0 1 2
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    42.1 ± 12.5 43 ± 11.4 44.3 ± 12.3 71.5 ± 7.2 69.8 ± 6.4 71 ± 6.6 -
    Gender categorical
    Units: Subjects
        Female
    51 57 54 36 28 24 250
        Male
    48 43 47 18 23 21 200
    Influenza vaccination 2008/2009
    Units: Subjects
        Yes
    19 22 24 46 47 40 198
        No
    80 78 77 8 4 5 252
    Influenza vaccination 2007/2008
    Units: Subjects
        Yes
    22 20 22 47 45 40 196
        No
    76 80 79 6 5 5 251
        Unknown
    1 0 0 1 1 0 3
    Influenza vaccination 2006/2007
    Units: Subjects
        Yes
    25 22 27 47 44 40 205
        No
    72 78 73 7 7 5 242
        Unknown
    2 0 1 0 0 0 3
    Influenza vaccination 2005/2006
    Units: Subjects
        Yes
    18 9 16 35 30 30 138
        No
    78 89 83 17 19 14 300
        Unknown
    3 2 2 2 2 1 12
    Influenza vaccination 2004/2005
    Units: Subjects
        Yes
    18 11 17 35 28 29 138
        No
    77 87 82 17 19 15 297
        Unknown
    4 2 2 2 4 1 15

    End points

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    End points reporting groups
    Reporting group title
    3.8 μg HA+AF03; 18-60 years
    Reporting group description
    Subjects aged 18-60 years who received two doses of adjuvanted A/H1N1 pandemic influenza vaccine (3.8 μg HA + AF03) 21 days apart.

    Reporting group title
    7.5 μg HA+AF03; 18-60 years
    Reporting group description
    Subjects aged 18-60 years who received two doses of adjuvanted A/H1N1 pandemic influenza vaccine (7.5 μg HA + AF03) 21 days apart.

    Reporting group title
    15 μg HA; 18-60 years
    Reporting group description
    Subjects aged 18-60 years who received two doses of A/H1N1 pandemic influenza vaccine (15 μg HA) 21 days apart.

    Reporting group title
    3.8 μg HA+AF03; >60 years
    Reporting group description
    Subjects aged >60 years who received two doses of adjuvanted A/H1N1 pandemic influenza vaccine (3.8 μg HA + AF03) 21 days apart.

    Reporting group title
    7.5 μg HA+AF03; >60 years
    Reporting group description
    Subjects aged >60 years who received two doses of adjuvanted A/H1N1 pandemic influenza vaccine (7.5 μg HA + AF03) 21 days apart.

    Reporting group title
    15 μg HA; >60 years
    Reporting group description
    Subjects aged >60 years who received two doses of A/H1N1 pandemic influenza vaccine (15 μg HA) 21 days apart.

    Primary: Percentage of Subjects Age 18-60 Years with Antibody titers ≥10 (1/dil) Assayed by HAI Method Against A/California (H1N1) Strain Before and After Vaccination with Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant

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    End point title
    Percentage of Subjects Age 18-60 Years with Antibody titers ≥10 (1/dil) Assayed by HAI Method Against A/California (H1N1) Strain Before and After Vaccination with Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant [1] [2]
    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 and Day 42 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.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive analyses were performed based on the study age agroup specified.
    End point values
    3.8 μg HA+AF03; 18-60 years 7.5 μg HA+AF03; 18-60 years 15 μg HA; 18-60 years
    Number of subjects analysed
    99
    100
    101
    Units: Percentage of subjects
    number (not applicable)
        Day 0
    44.4
    45
    40.6
        Day 21
    100
    100
    98
        Day 42
    100
    100
    100
    No statistical analyses for this end point

    Primary: Percentage of Subjects Age Over 60 Years with Antibody titers ≥10 (1/dil) Assayed by HAI Method Against A/California (H1N1) Strain Before and After Vaccination with Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant

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    End point title
    Percentage of Subjects Age Over 60 Years with Antibody titers ≥10 (1/dil) Assayed by HAI Method Against A/California (H1N1) Strain Before and After Vaccination with Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant [3] [4]
    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 and Day 42 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.
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive analyses were performed based on the study age agroup specified.
    End point values
    3.8 μg HA+AF03; >60 years 7.5 μg HA+AF03; >60 years 15 μg HA; >60 years
    Number of subjects analysed
    54
    51
    45
    Units: Percentage of subjects
    number (not applicable)
        Day 0
    59.3
    49
    45.5
        Day 21
    98.1
    97.9
    97.7
        Day 42
    100
    100
    100
    No statistical analyses for this end point

    Primary: Geometric Mean Titers (GMTs) of Antibody Assayed by HAI Method Against A/California (H1N1) Strain in Subjects Age 18-60 Years Before and After Vaccination with Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant

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    End point title
    Geometric Mean Titers (GMTs) of Antibody Assayed by HAI Method Against A/California (H1N1) Strain in Subjects Age 18-60 Years Before and After Vaccination with Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant [5] [6]
    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 and Day 42 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.
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive analyses were performed based on the study age agroup specified.
    End point values
    3.8 μg HA+AF03; 18-60 years 7.5 μg HA+AF03; 18-60 years 15 μg HA; 18-60 years
    Number of subjects analysed
    99
    100
    101
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Day 0
    10.9 (8.5 to 13.9)
    9.56 (7.98 to 11.4)
    10.5 (8.49 to 13)
        Day 21
    826 (624 to 1094)
    787 (625 to 990)
    514 (362 to 732)
        Day 42
    1205 (979 to 1482)
    1198 (997 to 1438)
    616 (464 to 819)
    No statistical analyses for this end point

    Primary: Geometric Mean Titers (GMTs) of Antibody Assayed by HAI Method Against A/California (H1N1) Strain in Subjects Over 60 Years Before and After Vaccination with Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant

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    End point title
    Geometric Mean Titers (GMTs) of Antibody Assayed by HAI Method Against A/California (H1N1) Strain in Subjects Over 60 Years Before and After Vaccination with Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant [7] [8]
    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 and Day 42 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.
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive analyses were performed based on the study age agroup specified.
    End point values
    3.8 μg HA+AF03; >60 years 7.5 μg HA+AF03; >60 years 15 μg HA; >60 years
    Number of subjects analysed
    54
    51
    45
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Day 0
    11.4 (8.88 to 14.6)
    10.7 (8.27 to 13.7)
    9.84 (7.69 to 12.6)
        Day 21
    184 (111 to 306)
    271 (179 to 411)
    182 (111 to 300)
        Day 42
    298 (201 to 442)
    414 (295 to 580)
    277 (184 to 416)
    No statistical analyses for this end point

    Primary: Percentage of Adult Subjects Age 18 to 60 Years Old with Seroprotection Against A/California (H1N1) Strain Before and Following Vaccination with Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant

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    End point title
    Percentage of Adult Subjects Age 18 to 60 Years Old with Seroprotection Against A/California (H1N1) Strain Before and Following Vaccination with Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant [9] [10]
    End point description
    Immunogenicity was evaluated using the hemagglutination inhibition (HAI) method. Seroprotection was defined as antibody titers ≥40 (1/[dil]).
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 and Day 42 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.
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive analyses were performed based on the study age agroup specified.
    End point values
    3.8 μg HA+AF03; 18-60 years 7.5 μg HA+AF03; 18-60 years 15 μg HA; 18-60 years
    Number of subjects analysed
    99
    100
    101
    Units: Percentage of subjects
    number (not applicable)
        Day 0
    14.1
    10
    14.9
        Day 21
    97
    99
    93
        Day 42
    100
    100
    98
    No statistical analyses for this end point

    Primary: Percentage of Elderly Subjects Age Over 60 Years Old with Seroprotection Against A/California (H1N1) Strain Before and Following Vaccination with Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant

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    End point title
    Percentage of Elderly Subjects Age Over 60 Years Old with Seroprotection Against A/California (H1N1) Strain Before and Following Vaccination with Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant [11] [12]
    End point description
    Immunogenicity was evaluated using the hemagglutination inhibition (HAI) method. Seroprotection was defined as antibody titers ≥40 (1/[dil]).
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 and Day 42 post-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 analyses were performed based on the study groups and the study vaccine administered for this outcome.
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive analyses were performed based on the study age agroup specified.
    End point values
    3.8 μg HA+AF03; >60 years 7.5 μg HA+AF03; >60 years 15 μg HA; >60 years
    Number of subjects analysed
    54
    51
    45
    Units: Percentage of subjects
    number (not applicable)
        Day 0
    14.8
    10.2
    9.1
        Day 21
    83.3
    89.6
    83.7
        Day 42
    96.3
    96
    95.3
    No statistical analyses for this end point

    Primary: Percentage of Subjects Age 18-60 Years Achieving Seroconversion or significant increase in Antibody Assayed by HAI Method Against A/California (H1N1) Strain After Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant

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    End point title
    Percentage of Subjects Age 18-60 Years Achieving Seroconversion or significant increase in Antibody Assayed by HAI Method Against A/California (H1N1) Strain After Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant [13] [14]
    End point description
    Immunogenicity was evaluated using the hemagglutination inhibition (HAI) method. Seroconversion for subjects with a pre-vaccination titer <10 (1/dil) on D0, post-vaccination titer ≥40 (1/dil) or significant increase for subjects with a pre-vaccination titer ≥10 (1/dil), ≥4-fold increase of the titer (post/pre).
    End point type
    Primary
    End point timeframe
    Day 21 and Day 42 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 analyses were performed based on the study groups and the study vaccine administered for this outcome.
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive analyses were performed based on the study age agroup specified.
    End point values
    3.8 μg HA+AF03; 18-60 years 7.5 μg HA+AF03; 18-60 years 15 μg HA; 18-60 years
    Number of subjects analysed
    99
    100
    101
    Units: Percentage of subjects
    number (not applicable)
        Day 21
    93.9
    98
    92
        Day 42
    99
    100
    96
    No statistical analyses for this end point

    Primary: Percentage of Subjects Over 60 Years Achieving Seroconversion or significant increase in Antibody Assayed by HAI Method Against A/California (H1N1) Strain After Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant

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    End point title
    Percentage of Subjects Over 60 Years Achieving Seroconversion or significant increase in Antibody Assayed by HAI Method Against A/California (H1N1) Strain After Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant [15] [16]
    End point description
    Immunogenicity was evaluated using the hemagglutination inhibition (HAI) method. Seroconversion for subjects with a pre-vaccination titer <10 (1/dil) on D0, post-vaccination titer ≥40 (1/dil) or significant increase for subjects with a pre-vaccination titer ≥10 (1/dil), ≥4-fold increase of the titer (post/pre).
    End point type
    Primary
    End point timeframe
    Day 21 and Day 42 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 analyses were performed based on the study groups and the study vaccine administered for this outcome.
    [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive analyses were performed based on the study age agroup specified.
    End point values
    3.8 μg HA+AF03; >60 years 7.5 μg HA+AF03; >60 years 15 μg HA; >60 years
    Number of subjects analysed
    54
    51
    45
    Units: Percentage of subjects
    number (not applicable)
        Day 21
    74.1
    85.4
    81.4
        Day 42
    90.7
    93.8
    90.7
    No statistical analyses for this end point

    Primary: Geometric Mean Titers of Neutralizing Antibody Assayed by Seroneutralization Method Against A/California (H1N1) Strain in Subjects Age 18-60 Years Before and After Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant

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    End point title
    Geometric Mean Titers of Neutralizing Antibody Assayed by Seroneutralization Method Against A/California (H1N1) Strain in Subjects Age 18-60 Years Before and After Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant [17] [18]
    End point description
    Immunogenicity was evaluated using the seroneutralization method.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 and Day 42 post-vaccination
    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 analyses were performed based on the study groups and the study vaccine administered for this outcome.
    [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive analyses were performed based on the study age agroup specified.
    End point values
    3.8 μg HA+AF03; 18-60 years 7.5 μg HA+AF03; 18-60 years 15 μg HA; 18-60 years
    Number of subjects analysed
    99
    100
    101
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Day 0
    21.6 (15.6 to 29.9)
    16.7 (12.7 to 22)
    16.4 (12.1 to 22.2)
        Day 21
    2972 (2273 to 3885)
    2580 (1975 to 3371)
    1500 (1050 to 2143)
        Day 42
    4316 (3522 to 5290)
    4203 (3395 to 5203)
    1976 (1466 to 2664)
    No statistical analyses for this end point

    Primary: Geometric Mean Titers of Neutralizing Antibody Assayed by Seroneutralization Method Against A/California (H1N1) Strain in Subjects Over 60 Years Before and After Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant

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    End point title
    Geometric Mean Titers of Neutralizing Antibody Assayed by Seroneutralization Method Against A/California (H1N1) Strain in Subjects Over 60 Years Before and After Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant [19] [20]
    End point description
    Immunogenicity was evaluated using the seroneutralization method.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 and Day 42 post-vaccination
    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 analyses were performed based on the study groups and the study vaccine administered for this outcome.
    [20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive analyses were performed based on the study age agroup specified.
    End point values
    3.8 μg HA+AF03; >60 years 7.5 μg HA+AF03; >60 years 15 μg HA; >60 years
    Number of subjects analysed
    54
    51
    45
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Day 0
    21.6 (14.8 to 31.5)
    22.7 (15.5 to 33.3)
    17.9 (11.7 to 27.5)
        Day 21
    536 (314 to 914)
    788 (498 to 1246)
    576 (343 to 968)
        Day 42
    884 (567 to 1377)
    1315 (912 to 1896)
    822 (523 to 1291)
    No statistical analyses for this end point

    Primary: Percentage of Subjects Age 18-60 Years with Neutralizing Antibody titers ≥40 (1/dil) Assayed by Seroneutralization Method Against A/California (H1N1) Strain After Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant

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    End point title
    Percentage of Subjects Age 18-60 Years with Neutralizing Antibody titers ≥40 (1/dil) Assayed by Seroneutralization Method Against A/California (H1N1) Strain After Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant [21] [22]
    End point description
    Immunogenicity was evaluated using the seroneutralization method.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 and Day 42 post-vaccination
    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 analyses were performed based on the study groups and the study vaccine administered for this outcome.
    [22] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive analyses were performed based on the study age agroup specified.
    End point values
    3.8 μg HA+AF03; 18-60 years 7.5 μg HA+AF03; 18-60 years 15 μg HA; 18-60 years
    Number of subjects analysed
    99
    100
    101
    Units: Percentage of subjects
    number (not applicable)
        Day 0
    29.3
    23
    29
        Day 21
    99
    99
    97
        Day 42
    100
    99
    98
    No statistical analyses for this end point

    Primary: Percentage of Subjects Age Over 60 Years with Neutralizing Antibody titers ≥40 (1/dil) Assayed by Seroneutralization Method Against A/California (H1N1) Strain After Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant

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    End point title
    Percentage of Subjects Age Over 60 Years with Neutralizing Antibody titers ≥40 (1/dil) Assayed by Seroneutralization Method Against A/California (H1N1) Strain After Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant [23] [24]
    End point description
    Immunogenicity was evaluated using the seroneutralization method.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 and Day 42 post-vaccination
    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 analyses were performed based on the study groups and the study vaccine administered for this outcome.
    [24] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive analyses were performed based on the study age agroup specified.
    End point values
    3.8 μg HA+AF03; >60 years 7.5 μg HA+AF03; >60 years 15 μg HA; >60 years
    Number of subjects analysed
    54
    51
    45
    Units: Percentage of subjects
    number (not applicable)
        Day 0
    33.3
    31.4
    28.9
        Day 21
    94.4
    94.1
    93.2
        Day 42
    98.1
    100
    97.7
    No statistical analyses for this end point

    Primary: Percentage of Subjects Age 18-60 Years with 2- and 4-fold Increase in Neutralizing Antibody titers Assayed by Seroneutralization Method Against A/California (H1N1) Strain After Inactivated, Split Virion A/H1N1 Influenza Vaccine With or Without Adjuvant

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    End point title
    Percentage of Subjects Age 18-60 Years with 2- and 4-fold Increase in Neutralizing Antibody titers Assayed by Seroneutralization Method Against A/California (H1N1) Strain After Inactivated, Split Virion A/H1N1 Influenza Vaccine With or Without Adjuvant [25] [26]
    End point description
    Immunogenicity was evaluated using the seroneutralization method.
    End point type
    Primary
    End point timeframe
    Day 21 and Day 42 post-vaccination
    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 analyses were performed based on the study groups and the study vaccine administered for this outcome.
    [26] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive analyses were performed based on the study age agroup specified.
    End point values
    3.8 μg HA+AF03; 18-60 years 7.5 μg HA+AF03; 18-60 years 15 μg HA; 18-60 years
    Number of subjects analysed
    99
    100
    101
    Units: Percentage of subjects
    number (not applicable)
        2-fold increase; Day 21
    98
    99
    98
        2-fold increase; Day 42
    99
    100
    99
        4-fold increase; Day 21
    94.9
    98
    96
        4-fold increase; Day 42
    95.9
    99
    97
    No statistical analyses for this end point

    Primary: Percentage of Subjects Over 60 Years with 2- and 4-fold Increase in Neutralizing Antibody titers Assayed by Seroneutralization Method Against A/California (H1N1) Strain After Inactivated, Split Virion A/H1N1 Influenza Vaccine With or Without Adjuvant

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    End point title
    Percentage of Subjects Over 60 Years with 2- and 4-fold Increase in Neutralizing Antibody titers Assayed by Seroneutralization Method Against A/California (H1N1) Strain After Inactivated, Split Virion A/H1N1 Influenza Vaccine With or Without Adjuvant [27] [28]
    End point description
    Immunogenicity was evaluated using the seroneutralization method.
    End point type
    Primary
    End point timeframe
    Day 21 and Day 42 post-vaccination
    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 analyses were performed based on the study groups and the study vaccine administered for this outcome.
    [28] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive analyses were performed based on the study age agroup specified.
    End point values
    3.8 μg HA+AF03; >60 years 7.5 μg HA+AF03; >60 years 15 μg HA; >60 years
    Number of subjects analysed
    54
    51
    45
    Units: Percentage of subjects
    number (not applicable)
        2-fold increase; Day 21
    94.4
    94.1
    93.2
        2-fold increase; Day 42
    94.4
    98
    97.7
        4-fold increase; Day 21
    85.2
    86.3
    88.6
        4-fold increase; Day 42
    88.9
    96
    86.4
    No statistical analyses for this end point

    Primary: Percentage of Subjects Age 18-60 Years Old Achieving Seroconversion or significant increase in Antibody Assayed by SRH Method Against A/California (H1N1) Strain After Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant

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    End point title
    Percentage of Subjects Age 18-60 Years Old Achieving Seroconversion or significant increase in Antibody Assayed by SRH Method Against A/California (H1N1) Strain After Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant [29] [30]
    End point description
    Immunogenicity was evaluated using Single radial hemolysis (SRH) testing. Seroconversion for subjects with a pre-vaccination titer ≤4 mm² on Day 0: post-injection titer ≥25 mm² on Day 21 or Day 42 or Significant increase for subjects with a pre-vaccination titer >4 mm²: ≥1.5-fold increase of post-injection titer on Day 21 or Day 42.
    End point type
    Primary
    End point timeframe
    Day 21 and Day 42 post-vaccination
    Notes
    [29] - 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.
    [30] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive analyses were performed based on the study age agroup specified.
    End point values
    3.8 μg HA+AF03; 18-60 years 7.5 μg HA+AF03; 18-60 years 15 μg HA; 18-60 years
    Number of subjects analysed
    99
    100
    101
    Units: Percentage of subjects
    number (not applicable)
        Day 21
    92.9
    91.9
    87.1
        Day 42
    98
    98
    95
    No statistical analyses for this end point

    Primary: Percentage of Subjects Over 60 Years Old Achieving Seroconversion or significant increase in Antibody Assayed by SRH Method Against A/California (H1N1) Strain After Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant

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    End point title
    Percentage of Subjects Over 60 Years Old Achieving Seroconversion or significant increase in Antibody Assayed by SRH Method Against A/California (H1N1) Strain After Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant [31] [32]
    End point description
    Immunogenicity was evaluated using Single radial hemolysis (SRH) testing. Seroconversion for subjects with a pre-vaccination titer ≤4 mm² on Day 0: post-injection titer ≥25 mm² on Day 21 or Day 42 or Significant increase for subjects with a pre-vaccination titer >4 mm²: ≥1.5-fold increase of post-injection titer on Day 21 or Day 42.
    End point type
    Primary
    End point timeframe
    Day 21 and Day 42 post-vaccination
    Notes
    [31] - 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.
    [32] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive analyses were performed based on the study age agroup specified.
    End point values
    3.8 μg HA+AF03; >60 years 7.5 μg HA+AF03; >60 years 15 μg HA; >60 years
    Number of subjects analysed
    54
    51
    45
    Units: Percentage of subjects
    number (not applicable)
        Day 21
    64.8
    74.5
    72.7
        Day 42
    87
    84
    90.9
    No statistical analyses for this end point

    Primary: Percentage of Adult Subjects Age 18 to 60 Years Old Reporting Solicited Injection-site or Systemic Reactions After Any Vaccination with Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant

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    End point title
    Percentage of Adult Subjects Age 18 to 60 Years Old Reporting Solicited Injection-site or Systemic Reactions After Any Vaccination with Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant [33] [34]
    End point description
    Solicited injection site: Pain, Erythema, Swelling, Induration and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3 Solicited Injection site reactions: Pain – 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 7-post any vaccination
    Notes
    [33] - 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.
    [34] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive analyses were performed based on the study age agroup specified.
    End point values
    3.8 μg HA+AF03; 18-60 years 7.5 μg HA+AF03; 18-60 years 15 μg HA; 18-60 years
    Number of subjects analysed
    99
    100
    101
    Units: Percentage of subjects
    number (not applicable)
        Inj. site Pain
    69.7
    59
    24.8
        Inj. site Pain; Post-inj. 1
    63.6
    55
    12.9
        Inj. site Pain; Post-inj. 2
    44.4
    38.4
    18.8
        Grade 3 Inj. site Pain
    4
    2
    0
        Grade 3 Inj. site Pain; Post-inj. 1
    2
    2
    0
        Grade 3 Inj. site Pain; Post-inj. 2
    2
    0
    0
        Inj. site Erythema
    7.1
    10
    2
        Inj. site Erythema; Post-inj. 1
    5.1
    10
    1
        Inj. site Erythema; Post-inj. 2
    3
    3
    1
        Grade 3 Inj. site Erythema
    0
    1
    0
        Grade 3 Inj. site Erythema; Post-inj. 1
    0
    0
    0
        Grade 3 Inj. site Erythema; Post-inj. 2
    0
    1
    0
        Inj. site Swelling
    6.1
    5
    3
        Inj. site Swelling; Post-inj. 1
    2
    3
    2
        Inj. site Swelling; Post-inj. 2
    5.1
    2
    2
        Grade 3 Inj. site Swelling
    0
    0
    0
        Grade 3 Inj. site Swelling; Post-inj. 1
    0
    0
    0
        Grade 3 Inj. site Swelling; Post-inj. 2
    0
    0
    0
        Inj. site Induration
    7.1
    9
    1
        Inj. site Induration; Post-inj. 1
    6.1
    6
    0
        Inj. site Induration; Post-inj. 2
    4
    4
    1
        Grade 3 Inj. site Induration
    0
    0
    0
        Grade 3 Inj. site Induration; Post-inj. 1
    0
    0
    0
        Grade 3 Inj. site Induration; Post-inj. 2
    0
    0
    0
        Inj. site Ecchymosis
    2
    0
    0
        Inj. site Ecchymosis; Post-inj. 1
    1
    0
    0
        Inj. site Ecchymosis; Post-inj. 2
    1
    0
    0
        Grade 3 Inj. site Ecchymosis
    0
    0
    0
        Grade 3 Inj. site Ecchymosis; Post-inj. 1
    0
    0
    0
        Grade 3 Inj. site Ecchymosis; Post-inj. 2
    0
    0
    0
        Solicited inj. site reaction
    70.7
    62
    27.7
        Solicited inj. site reaction; Post-inj. 1
    64.6
    58
    14.9
        Solicited inj. site reaction; Post-inj. 2
    47.5
    40.4
    20.8
        Grade 3 Solicited inj. site reaction
    4
    3
    0
        Grade 3 Solicited inj. site reaction; Post-inj. 1
    2
    2
    0
        Grade 3 Solicited inj. site reaction; Post-inj. 2
    2
    1
    0
        Fever
    5.1
    2
    2
        Fever; Post-inj. 1
    1
    1
    1
        Fever; Post-inj. 2
    4
    1
    1
        Grade 3 Fever
    0
    1
    0
        Grade 3 Fever; Post-inj. 1
    0
    1
    0
        Grade 3 Fever; Post-inj. 2
    0
    0
    0
        Headache
    36.4
    31
    30.7
        Headache; Post-inj. 1
    28.3
    24
    25.7
        Headache; Post-inj. 2
    16.2
    17.2
    12.9
        Grade 3 Headache
    1
    1
    0
        Grade 3 Headache; Post-inj. 1
    0
    1
    0
        Grade 3 Headache; Post-inj. 2
    1
    0
    0
        Malaise
    14.1
    18
    10.9
        Malaise; Post-inj. 1
    9.1
    15
    7.9
        Malaise; Post-inj. 2
    7.1
    12.1
    5.9
        Grade 3 Malaise
    2
    1
    0
        Grade 3 Malaise; Post-inj. 1
    1
    0
    0
        Grade 3 Malaise; Post-inj. 2
    1
    1
    0
        Myalgia
    40.4
    37
    24.8
        Myalgia; Post-inj. 1
    33.3
    33
    16.8
        Myalgia; Post-inj. 2
    20.2
    19.2
    16.8
        Grade 3 Myalgia
    1
    3
    0
        Grade 3 Myalgia; Post-inj. 1
    0
    2
    0
        Grade 3 Myalgia; Post-inj. 2
    1
    2
    0
        Shivering
    9.1
    19
    6.9
        Shivering; Post-inj. 1
    3
    14
    4
        Shivering; Post-inj. 2
    6.1
    12.1
    4
        Grade 3 Shivering
    1
    2
    0
        Grade 3 Shivering; Post-inj. 1
    0
    1
    0
        Grade 3 Shivering; Post-inj. 2
    1
    1
    0
        Solicited systemic reaction
    56.6
    48
    45.5
        Solicited systemic reaction; Post-inj. 1
    45.5
    43
    35.6
        Solicited systemic reaction; Post-inj. 2
    30.3
    31.3
    24.8
        Grade 3 Systemic reaction
    2
    3
    0
        Grade 3 Systemic reaction; Post-inj. 1
    1
    2
    0
        Grade 3 Systemic reaction; Post-inj. 2
    1
    2
    0
    No statistical analyses for this end point

    Primary: Percentage of Elderly Subjects Age Over 60 Years Old Reporting Solicited Injection-site or Systemic Reactions After Any Vaccination with Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant

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    End point title
    Percentage of Elderly Subjects Age Over 60 Years Old Reporting Solicited Injection-site or Systemic Reactions After Any Vaccination with Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant [35] [36]
    End point description
    Solicited injection site: Pain, Erythema, Swelling, Induration and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3 Solicited Injection site reactions: Pain – 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 7-post any vaccination
    Notes
    [35] - 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.
    [36] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive analyses were performed based on the study age agroup specified.
    End point values
    3.8 μg HA+AF03; >60 years 7.5 μg HA+AF03; >60 years 15 μg HA; >60 years
    Number of subjects analysed
    54
    51
    45
    Units: Percentage of subjects
    number (not applicable)
        Inj. site Pain
    29.6
    51
    17.8
        Inj. site Pain; Post-inj. 1
    16.7
    43.1
    4.4
        Inj. site Pain; Post-inj. 2
    18.5
    37.3
    15.9
        Grade 3 Inj. site Pain
    0
    0
    0
        Grade 3 Inj. site Pain; Post-inj. 1
    0
    0
    0
        Grade 3 Inj. site Pain; Post-inj. 2
    0
    0
    0
        Inj. site Erythema
    5.6
    21.6
    2.2
        Inj. site Erythema; Post-inj. 1
    3.7
    15.7
    2.2
        Inj. site Erythema; Post-inj. 2
    1.9
    7.8
    0
        Grade 3 Inj. site Erythema
    0
    0
    0
        Grade 3 Inj. site Erythema; Post-inj. 1
    0
    0
    0
        Grade 3 Inj. site Erythema; Post-inj. 2
    0
    0
    0
        Inj. site Swelling
    5.6
    7.8
    0
        Inj. site Swelling; Post-inj. 1
    5.6
    5.9
    0
        Inj. site Swelling; Post-inj. 2
    1.9
    2
    0
        Grade 3 Inj. site Swelling
    0
    0
    0
        Grade 3 Inj. site Swelling; Post-inj. 1
    0
    0
    0
        Grade 3 Inj. site Swelling; Post-inj. 2
    0
    0
    0
        Inj. site Induration
    3.7
    7.8
    0
        Inj. site Induration; Post-inj. 1
    1.9
    5.9
    0
        Inj. site Induration; Post-inj. 2
    1.9
    2
    0
        Grade 3 Inj. site Induration
    0
    0
    0
        Grade 3 Inj. site Induration; Post-inj. 1
    0
    0
    0
        Grade 3 Inj. site Induration; Post-inj. 2
    0
    0
    0
        Inj. site Ecchymosis
    1.9
    2
    2.2
        Inj. site Ecchymosis; Post-inj. 1
    1.9
    2
    0
        Inj. site Ecchymosis; Post-inj. 2
    0
    0
    2.3
        Grade 3 Inj. site Ecchymosis
    0
    0
    0
        Grade 3 Inj. site Ecchymosis; Post-inj. 1
    0
    0
    0
        Grade 3 Inj. site Ecchymosis; Post-inj. 2
    0
    0
    0
        Solicited injection site reaction
    35.2
    54.9
    22.2
        Solicited injection site reaction; Post-inj. 1
    20.4
    45.1
    6.7
        Solicited injection site reaction; Post-inj. 2
    20.4
    39.2
    18.2
        Grade 3 Solicited injection site reaction
    0
    0
    0
        Grade 3 Solicited inj. site reaction; Post-inj. 1
    0
    0
    0
        Grade 3 Solicited inj. site reaction; Post-inj. 2
    0
    0
    0
        Fever
    1.9
    3.9
    0
        Fever; Post-inj. 1
    0
    3.9
    0
        Fever; Post-inj. 2
    1.9
    0
    0
        Grade 3 Fever
    0
    0
    0
        Grade 3 Fever; Post-inj. 1
    0
    0
    0
        Grade 3 Fever; Post-inj. 2
    0
    0
    0
        Headache
    14.8
    7.8
    15.6
        Headache; Post-inj. 1
    5.6
    5.9
    8.9
        Headache; Post-inj. 2
    11.1
    3.9
    11.4
        Grade 3 Headache
    0
    0
    0
        Grade 3 Headache; Post-inj. 1
    0
    0
    0
        Grade 3 Headache; Post-inj. 2
    0
    0
    0
        Malaise
    5.6
    5.9
    8.9
        Malaise; Post-inj. 1
    3.7
    5.9
    8.9
        Malaise; Post-inj. 2
    1.9
    3.9
    0
        Grade 3 Malaise
    0
    0
    0
        Grade 3 Malaise; Post-inj. 1
    0
    0
    0
        Grade 3 Malaise; Post-inj. 2
    0
    0
    0
        Myalgia
    7.4
    15.7
    15.6
        Myalgia; Post-inj. 1
    3.7
    11.8
    11.1
        Myalgia; Post-inj. 2
    7.4
    5.9
    11.4
        Grade 3 Myalgia
    0
    0
    0
        Grade 3 Myalgia; Post-inj. 1
    0
    0
    0
        Grade 3 Myalgia; Post-inj. 2
    0
    0
    0
        Shivering
    1.9
    7.8
    0
        Shivering; Post-inj. 1
    0
    5.9
    0
        Shivering; Post-inj. 2
    1.9
    3.9
    0
        Grade 3 Shivering
    0
    0
    0
        Grade 3 Shivering; Post-inj. 1
    0
    0
    0
        Grade 3 Shivering; Post-inj. 2
    0
    0
    0
        Solicited systemic reaction
    18.5
    21.6
    22.2
        Solicited systemic reaction; Post-inj. 1
    9.3
    17.6
    13.3
        Solicited systemic reaction; Post-inj. 2
    13
    7.8
    18.2
        Grade 3 Solicited systemic reaction
    0
    0
    0
        Grade 3 Solicited systemic reaction; Post-inj. 1
    0
    0
    0
        Grade 3 Solicited systemic reaction; Post-inj. 2
    0
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of Adult Subjects Age 18-60 Years Old with at Least One Solicited Reactions Listed in the EMA Note for Guidance Within 3 Days After Each Vaccination with Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant

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    End point title
    Percentage of Adult Subjects Age 18-60 Years Old with at Least One Solicited Reactions Listed in the EMA Note for Guidance Within 3 Days After Each Vaccination with Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant [37] [38]
    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-any vaccination
    Notes
    [37] - 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.
    [38] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive analyses were performed based on the study age agroup specified.
    End point values
    3.8 μg HA+AF03; 18-60 years 7.5 μg HA+AF03; 18-60 years 15 μg HA; 18-60 years
    Number of subjects analysed
    99
    100
    101
    Units: Percentage of subjects
    number (not applicable)
        Reaction listed in the EMA recommendations
    24.2
    32
    16.8
        Reaction listed in EMA recommendation; Post-inj. 1
    16.2
    21
    12.9
        Reaction listed in EMA recommendation; Post-inj. 2
    12.1
    20.2
    6.9
        Inj. site induration ≥5 cm for 4 days
    0
    0
    0
        Inj. site induration ≥5 cm for 4 days; Post-inj. 1
    0
    0
    0
        Inj. site induration ≥5 cm for 4 days; Post-inj. 2
    0
    0
    0
        Inj. site Ecchymosis
    9.1
    5
    4
        Inj. site Ecchymosis; Post-inj. 1
    5.1
    5
    2
        Inj. site Ecchymosis; Post-inj. 2
    4
    0
    3
        Pyrexia (temp. >38°C) for 1 day
    1
    1
    0
        Pyrexia (temp. >38°C) for 1 day; Post-inj. 1
    0
    0
    0
        Pyrexia (temp. >38°C) for 1 day; Post-inj. 2
    1
    1
    0
        Malaise
    13.1
    17
    9.9
        Malaise; Post-inj. 1
    8.1
    12
    7.9
        Malaise; Post-inj. 2
    7.1
    12.1
    3
        Shivering
    9.1
    17
    5
        Shivering; Post-inj. 1
    3
    10
    4
        Shivering; Post-inj. 2
    6.1
    11.1
    2
    No statistical analyses for this end point

    Primary: Percentage of Elderly Subjects Age Over 60 Years with at Least One Solicited Reactions Listed in the EMA Note for Guidance Within 3 Days After Each Vaccination with Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant

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    End point title
    Percentage of Elderly Subjects Age Over 60 Years with at Least One Solicited Reactions Listed in the EMA Note for Guidance Within 3 Days After Each Vaccination with Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant [39] [40]
    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-any vaccination
    Notes
    [39] - 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.
    [40] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Descriptive analyses were performed based on the study age agroup specified.
    End point values
    3.8 μg HA+AF03; >60 years 7.5 μg HA+AF03; >60 years 15 μg HA; >60 years
    Number of subjects analysed
    54
    51
    45
    Units: Percentage of subjects
    number (not applicable)
        Reaction listed in the EMA recommendations
    9.3
    15.7
    6.7
        Reaction listed in EMA recommendation; Post-inj. 1
    5.6
    13.7
    6.7
        Reaction listed in EMA recommendation; Post-inj. 2
    3.7
    5.9
    2.3
        Inj. site Induration ≥5 cm for 4 days
    0
    0
    0
        Inj. site Induration ≥5 cm for 4 days; Post-inj. 1
    0
    0
    0
        Inj. site Induration ≥5 cm for 4 days; Post-inj. 2
    0
    0
    0
        Inj. site Ecchymosis
    5.6
    3.9
    6.7
        Inj. site Ecchymosis; Post-inj. 1
    3.7
    3.9
    6.7
        Inj. site Ecchymosis; Post-inj. 2
    1.9
    0
    2.3
        Pyrexia (> 38°C) for 1 day
    1.9
    3.9
    0
        Pyrexia (> 38°C) for 1 day; Post-inj. 1
    0
    3.9
    0
        Pyrexia (> 38°C) for 1 day; Post-inj. 2
    1.9
    0
    0
        Malaise
    3.7
    5.9
    2.2
        Malaise; Post-inj. 1
    3.7
    5.9
    2.2
        Malaise; Post-inj. 2
    0
    3.9
    0
        Shivering
    1.9
    7.8
    0
        Shivering; Post-inj. 1
    0
    5.9
    0
        Shivering; Post-inj. 2
    1.9
    3.9
    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 6 months post-vaccination.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    12.0
    Reporting groups
    Reporting group title
    3.8 μg HA+AF03; 18-60 years
    Reporting group description
    Subjects aged 18-60 years who received two doses of adjuvanted A/H1N1 pandemic influenza vaccine (3.8 μg HA + AF03) 21 days apart.

    Reporting group title
    7.5 μg HA+AF03; 18-60 years
    Reporting group description
    Subjects aged 18-60 years who received two doses of adjuvanted A/H1N1 pandemic influenza vaccine (7.5 μg HA + AF03) 21 days apart.

    Reporting group title
    15 μg HA; 18-60 years
    Reporting group description
    Subjects aged 18-60 years who received two doses of A/H1N1 pandemic influenza vaccine (15 μg HA) 21 days apart.

    Reporting group title
    3.8 μg HA+AF03; >60 years
    Reporting group description
    Subjects aged >60 years who received two doses of adjuvanted A/H1N1 pandemic influenza vaccine (3.8 μg HA + AF03) 21 days apart.

    Reporting group title
    7.5 μg HA+AF03; >60 years
    Reporting group description
    Subjects aged >60 years who received two doses of adjuvanted A/H1N1 pandemic influenza vaccine (7.5 μg HA + AF03) 21 days apart.

    Reporting group title
    15 μg HA; >60 years
    Reporting group description
    Subjects aged >60 years who received two doses of A/H1N1 pandemic influenza vaccine (15 μg HA) 21 days apart.

    Serious adverse events
    3.8 μg HA+AF03; 18-60 years 7.5 μg HA+AF03; 18-60 years 15 μg HA; 18-60 years 3.8 μg HA+AF03; >60 years 7.5 μg HA+AF03; >60 years 15 μg HA; >60 years
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 99 (2.02%)
    6 / 100 (6.00%)
    7 / 101 (6.93%)
    1 / 54 (1.85%)
    7 / 51 (13.73%)
    2 / 45 (4.44%)
         number of deaths (all causes)
    0
    0
    0
    0
    2
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Vascular disorders
    Phlebitis
         subjects affected / exposed
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    1 / 101 (0.99%)
    0 / 54 (0.00%)
    0 / 51 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Femoral neck fracture
         subjects affected / exposed
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    0 / 54 (0.00%)
    1 / 51 (1.96%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Open wound
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 100 (1.00%)
    0 / 101 (0.00%)
    0 / 54 (0.00%)
    0 / 51 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    0 / 54 (0.00%)
    1 / 51 (1.96%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchial carcinoma
         subjects affected / exposed
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    0 / 54 (0.00%)
    2 / 51 (3.92%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 0
    Hodgkin's disease
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 100 (1.00%)
    0 / 101 (0.00%)
    0 / 54 (0.00%)
    0 / 51 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Malignant melanoma
         subjects affected / exposed
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    0 / 54 (0.00%)
    1 / 51 (1.96%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Non-Hodgkin's lymphoma
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 100 (1.00%)
    0 / 101 (0.00%)
    0 / 54 (0.00%)
    0 / 51 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Prostatic adenoma
         subjects affected / exposed
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    1 / 54 (1.85%)
    0 / 51 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal cancer
         subjects affected / exposed
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    1 / 101 (0.99%)
    0 / 54 (0.00%)
    0 / 51 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Thyroid cancer
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 100 (1.00%)
    0 / 101 (0.00%)
    0 / 54 (0.00%)
    0 / 51 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tonsil cancer
         subjects affected / exposed
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    1 / 54 (1.85%)
    0 / 51 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Atrioventricular block
         subjects affected / exposed
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    0 / 54 (0.00%)
    0 / 51 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    1 / 101 (0.99%)
    0 / 54 (0.00%)
    0 / 51 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    0 / 54 (0.00%)
    1 / 51 (1.96%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 100 (1.00%)
    0 / 101 (0.00%)
    0 / 54 (0.00%)
    0 / 51 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    0 / 54 (0.00%)
    0 / 51 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Papilloedema
         subjects affected / exposed
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    1 / 101 (0.99%)
    0 / 54 (0.00%)
    0 / 51 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Malaise
         subjects affected / exposed
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    0 / 54 (0.00%)
    0 / 51 (0.00%)
    1 / 45 (2.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Alcoholism
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 100 (1.00%)
    0 / 101 (0.00%)
    0 / 54 (0.00%)
    0 / 51 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Brief psychotic disorder with marked stressors
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    0 / 54 (0.00%)
    0 / 51 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicide attempt
         subjects affected / exposed
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    1 / 101 (0.99%)
    0 / 54 (0.00%)
    0 / 51 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrooesphageal reflux disease
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 100 (1.00%)
    0 / 101 (0.00%)
    0 / 54 (0.00%)
    0 / 51 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sigmoiditis
         subjects affected / exposed
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    0 / 54 (0.00%)
    1 / 51 (1.96%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Foot deformity
         subjects affected / exposed
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    1 / 101 (0.99%)
    0 / 54 (0.00%)
    0 / 51 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    1 / 101 (0.99%)
    0 / 54 (0.00%)
    0 / 51 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    1 / 101 (0.99%)
    0 / 54 (0.00%)
    0 / 51 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 100 (1.00%)
    0 / 101 (0.00%)
    0 / 54 (0.00%)
    0 / 51 (0.00%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 99 (0.00%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    0 / 54 (0.00%)
    1 / 51 (1.96%)
    0 / 45 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    3.8 μg HA+AF03; 18-60 years 7.5 μg HA+AF03; 18-60 years 15 μg HA; 18-60 years 3.8 μg HA+AF03; >60 years 7.5 μg HA+AF03; >60 years 15 μg HA; >60 years
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    70 / 99 (70.71%)
    62 / 100 (62.00%)
    46 / 101 (45.54%)
    19 / 54 (35.19%)
    28 / 51 (54.90%)
    10 / 45 (22.22%)
    Nervous system disorders
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    36 / 99 (36.36%)
    31 / 100 (31.00%)
    31 / 101 (30.69%)
    0 / 54 (0.00%)
    0 / 51 (0.00%)
    0 / 45 (0.00%)
         occurrences all number
    36
    31
    31
    0
    0
    0
    General disorders and administration site conditions
    Injection site pain
    alternative assessment type: Systematic
         subjects affected / exposed
    69 / 99 (69.70%)
    59 / 100 (59.00%)
    25 / 101 (24.75%)
    0 / 54 (0.00%)
    0 / 51 (0.00%)
    0 / 45 (0.00%)
         occurrences all number
    69
    59
    25
    0
    0
    0
    Injection site erythema
    alternative assessment type: Systematic
         subjects affected / exposed
    7 / 99 (7.07%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    0 / 54 (0.00%)
    11 / 51 (21.57%)
    1 / 45 (2.22%)
         occurrences all number
    7
    0
    0
    0
    11
    1
    Injection site swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    6 / 99 (6.06%)
    0 / 100 (0.00%)
    3 / 101 (2.97%)
    0 / 54 (0.00%)
    4 / 51 (7.84%)
    0 / 45 (0.00%)
         occurrences all number
    6
    0
    3
    0
    4
    0
    Injection site ecchymosis
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 99 (2.02%)
    0 / 100 (0.00%)
    0 / 101 (0.00%)
    0 / 54 (0.00%)
    1 / 51 (1.96%)
    1 / 45 (2.22%)
         occurrences all number
    2
    0
    0
    0
    1
    1
    Fever
    alternative assessment type: Systematic
         subjects affected / exposed
    5 / 99 (5.05%)
    0 / 100 (0.00%)
    2 / 101 (1.98%)
    0 / 54 (0.00%)
    2 / 51 (3.92%)
    0 / 45 (0.00%)
         occurrences all number
    5
    0
    2
    0
    2
    0
    Malaise
    alternative assessment type: Systematic
         subjects affected / exposed
    14 / 99 (14.14%)
    18 / 100 (18.00%)
    11 / 101 (10.89%)
    0 / 54 (0.00%)
    0 / 51 (0.00%)
    0 / 45 (0.00%)
         occurrences all number
    14
    18
    11
    0
    0
    0
    Shivering
    alternative assessment type: Systematic
         subjects affected / exposed
    9 / 99 (9.09%)
    19 / 100 (19.00%)
    7 / 101 (6.93%)
    0 / 54 (0.00%)
    0 / 51 (0.00%)
    0 / 45 (0.00%)
         occurrences all number
    9
    19
    7
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Injection site induration
    alternative assessment type: Systematic
         subjects affected / exposed
    7 / 99 (7.07%)
    9 / 100 (9.00%)
    1 / 101 (0.99%)
    0 / 54 (0.00%)
    0 / 51 (0.00%)
    0 / 45 (0.00%)
         occurrences all number
    7
    9
    1
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Myalgia
    alternative assessment type: Systematic
         subjects affected / exposed
    40 / 99 (40.40%)
    37 / 100 (37.00%)
    25 / 101 (24.75%)
    0 / 54 (0.00%)
    0 / 51 (0.00%)
    0 / 45 (0.00%)
         occurrences all number
    40
    37
    25
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Mar 2010
    Included the assessment of the persistence of the immune response at 8 months after the first vaccination in a subset of subjects having received two vaccinations of the vaccines selected for licensure (the 3.8 μg HA + AF03 vaccine and the 15 μg HA without adjuvant vaccine).
    27 May 2010
    Assessed the potential effect of previous A/H1N1 influenza vaccination on the immune response to the 2010-2011 NH seasonal TIV.

    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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