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    Clinical Trial Results:
    Immunogenicity of the Intramuscular Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine Without Adjuvant in Healthy Adult Subjects

    Summary
    EudraCT number
    		 2010-018991-25
    Trial protocol
    		 FR  
    Global end of trial date
    21 Sep 2010

    Results information
    Results version number
    		 v1(current)
    This version publication date
    16 Feb 2016
    First version publication date
    27 Mar 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GPF18
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01089660
    WHO universal trial number (UTN)
    		 U1111-1112-8378
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur SA
    Sponsor organisation address
    2, avenue Pont Pasteur, Lyon cedex 07, France, 69367
    Public contact
    Director, Clinical Development, Sanofi Pasteur SA, 33 4 37 37 58 50, stephanie.pepin@sanofipasteur.com
    Scientific contact
    Director, Clinical Development, Sanofi Pasteur SA, 33 4 37 37 58 50, stephanie.pepin@sanofipasteur.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    23 Dec 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Sep 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • To describe the immune response of the inactivated, split-virion swine-origin A/H1N1influenza vaccine without adjuvant in each group
    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
    16 Mar 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: 202
    Worldwide total number of subjects
    202
    EEA total number of subjects
    202
    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)
    202
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study subjects were enrolled from 16 March 2010 to 19 March 2010 at 2 clinical centers in France.

    Pre-assignment
    Screening details
    		 A total of 202 subjects who met all of the 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
    		 9 μg HA
    Arm description
    		 Subjects aged 18 to 60 years who received 9 μg (0.3 mL) of hemagglutinin (HA) of non-adjuvanted pandemic A/H1N1 influenza vaccine on Day 0.
    Arm type
    		 Experimental

    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
    0.3 mL (9 μg), intramuscular to be injected into the deltoid area, single injection on Day 0.

    Arm title
    		 15 μg HA
    Arm description
    		 Subjects aged 18 to 60 years who received 15 μg (0.5 mL) of hemagglutinin (HA) of non-adjuvanted pandemic A/H1N1 influenza vaccine on Day 0.
    Arm type
    		 Experimental

    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 (15 μg), intramuscular to be injected into the deltoid area, single injection on Day 0.

    Number of subjects in period 1
    		9 μg HA 15 μg HA
    Started
    102
    100
    Completed
    101
    99
    Not completed
    1
    1
         Consent withdrawn by subject
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    9 μg HA
    Reporting group description
    		 Subjects aged 18 to 60 years who received 9 μg (0.3 mL) of hemagglutinin (HA) of non-adjuvanted pandemic A/H1N1 influenza vaccine on Day 0.

    Reporting group title
    15 μg HA
    Reporting group description
    		 Subjects aged 18 to 60 years who received 15 μg (0.5 mL) of hemagglutinin (HA) of non-adjuvanted pandemic A/H1N1 influenza vaccine on Day 0.

    Reporting group values
    		 9 μg HA 15 μg HA Total
    Number of subjects
    		 102 100 202
    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)
    		 102 100 202
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 44.3 ± 12.1 43.9 ± 12.3 -
    Gender categorical
    Units: Subjects
        Female
    		 73 66 139
        Male
    		 29 34 63
    History of seasonal influenza vaccination during the 2009-2010 season
    Units: Subjects
        Yes
    		 9 6 15
        No
    		 93 94 187

    End points

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    End points reporting groups
    Reporting group title
    9 μg HA
    Reporting group description
    		 Subjects aged 18 to 60 years who received 9 μg (0.3 mL) of hemagglutinin (HA) of non-adjuvanted pandemic A/H1N1 influenza vaccine on Day 0.

    Reporting group title
    15 μg HA
    Reporting group description
    		 Subjects aged 18 to 60 years who received 15 μg (0.5 mL) of hemagglutinin (HA) of non-adjuvanted pandemic A/H1N1 influenza vaccine on Day 0.

    Primary: Geometric Mean Titers (GMTs) of Antibody Assayed by HAI Method Against A/California (H1N1) Influenza Strain in Healthy Adult Subjects Following Vaccination with Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine

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    End point title
    		 Geometric Mean Titers (GMTs) of Antibody Assayed by HAI Method Against A/California (H1N1) Influenza Strain in Healthy Adult Subjects Following Vaccination with Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine [1]
    End point description
    Anti-hemagglutinin (HA) antibody (Ab) titers against the swine-origin A/H1N1 strain measured with the hemagglutination inhibition (HAI) method.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 post-vaccination
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 9 μg HA 15 μg HA
    Number of subjects analysed
    102
    100
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Day 0 (pre-vaccination)
    11.3 (8.62 to 14.7)
    8.38 (6.89 to 10.2)
        Day 21 (post-vaccination)
    563 (422 to 752)
    801 (612 to 1047)
    No statistical analyses for this end point

    Primary: Percentage of Healthy Adult Subjects with Detectable Antibody titers ≥ 10 (1/dil) Assayed by HAI Method Against A/California (H1N1) Influenza Strain Following Vaccination with Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine

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    End point title
    		 Percentage of Healthy Adult Subjects with Detectable Antibody titers ≥ 10 (1/dil) Assayed by HAI Method Against A/California (H1N1) Influenza Strain Following Vaccination with Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine [2]
    End point description
    Anti-hemagglutinin (HA) antibody (Ab) titers against the swine-origin A/H1N1 strain measured with the hemagglutination inhibition (HAI) method. Detectable antibody titers were defined as titers ≥10 (1/dil) on Day 0 and 21.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 post-vaccination
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 9 μg HA 15 μg HA
    Number of subjects analysed
    102
    100
    Units: Percentage of subjects
    number (not applicable)
        Day 0 (pre-vaccination)
    35.3
    26
        Day 21 (post-vaccination)
    100
    100
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Seroprotection to A/California (H1N1) Influenza Strain Following Vaccination with Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine

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    End point title
    		 Percentage of Subjects with Seroprotection to A/California (H1N1) Influenza Strain Following Vaccination with Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine [3]
    End point description
    Anti-hemagglutinin (HA) antibody (Ab) titers against the swine-origin A/H1N1 strain measured with the hemagglutination inhibition (HAI) method. Seroprotection was defined as individual antibody titer ≥40 (1/dil) 21 days after vaccination.
    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
    		 9 μg HA 15 μg HA
    Number of subjects analysed
    102
    100
    Units: Percentage of subjects
    number (not applicable)
        Day 0 (pre-vaccination)
    19.6
    13
        Day 21 (post-vaccination)
    95.9
    98
    No statistical analyses for this end point

    Primary: Percentage of Healthy Adult Subjects Achieving Seroconversion or significant increase in Antibody Assayed by HAI Method Against A/California (H1N1) Influenza Strain After Vaccination with Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine

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    End point title
    		 Percentage of Healthy Adult Subjects Achieving Seroconversion or significant increase in Antibody Assayed by HAI Method Against A/California (H1N1) Influenza Strain After Vaccination with Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine [4]
    End point description
    Anti-hemagglutinin (HA) antibody (Ab) titers against the swine-origin A/H1N1 strain measured with the hemagglutination inhibition (HAI) method. Seroconversion was defined as subjects with a pre-vaccination titer <10 (1/dil) on Day 0, post-vaccination titer ≥40 (1/dil) and significant increase defined as subjects with a pre-vaccination titer ≥10 (1/dil), ≥four-fold increase of the titer (post/pre).
    End point type
    Primary
    End point timeframe
    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
    		 9 μg HA 15 μg HA
    Number of subjects analysed
    98
    99
    Units: Percentage of subjects
    number (not applicable)
        Day 21/Day 0
    90.8
    97
    No statistical analyses for this end point

    Primary: Geometric Mean Titers (GMTs) of Antibody Assayed by HAI Method Against A/California (H1N1) Influenza Strain in Healthy Adult Subjects Who Were Seronegative at Baseline After Vaccination with Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine

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    End point title
    		 Geometric Mean Titers (GMTs) of Antibody Assayed by HAI Method Against A/California (H1N1) Influenza Strain in Healthy Adult Subjects Who Were Seronegative at Baseline After Vaccination with Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine [5]
    End point description
    Anti-hemagglutinin (HA) antibody (Ab) titers against the swine-origin A/H1N1 strain measured with the hemagglutination inhibition (HAI) method.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 post-vaccination
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 9 μg HA 15 μg HA
    Number of subjects analysed
    66
    74
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Day 0 (pre-vaccination)
    5.08 (4.99 to 5.17)
    5.09 (5 to 5.19)
        Day 21 (post-vaccination)
    372 (260 to 534)
    616 (453 to 839)
    No statistical analyses for this end point

    Primary: Percentage of Adult Subjects Who Were Seronegative at Baseline with Detectable Antibody titers ≥10 (1/dil) Assayed by HAI Against A/California (H1N1) Influenza Strain After Vaccination with Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine

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    End point title
    		 Percentage of Adult Subjects Who Were Seronegative at Baseline with Detectable Antibody titers ≥10 (1/dil) Assayed by HAI Against A/California (H1N1) Influenza Strain After Vaccination with Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine [6]
    End point description
    Anti-hemagglutinin (HA) antibody (Ab) titers against the swine-origin A/H1N1 strain measured with the hemagglutination inhibition (HAI) method. Detectable antibody titers were defined as titers ≥10 (1/dil) on Day 0 and 21.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 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
    		 9 μg HA 15 μg HA
    Number of subjects analysed
    66
    74
    Units: Percentage of subjects
    number (not applicable)
        Day 0 (pre-vaccination)
    0
    0
        Day 21 (post-vaccination)
    100
    100
    No statistical analyses for this end point

    Primary: Percentage of Subjects Who Were Seronegative at Baseline with Seroprotection to A/California (H1N1) Influenza train Following Vaccination with Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine

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    End point title
    		 Percentage of Subjects Who Were Seronegative at Baseline with Seroprotection to A/California (H1N1) Influenza train Following Vaccination with Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine [7]
    End point description
    Anti-hemagglutinin (HA) antibody (Ab) titers against the swine-origin A/H1N1 strain measured with the hemagglutination inhibition (HAI) method. Seroprotection was defined as individual antibody titer ≥40 (1/dil) 21 days after vaccination.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 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
    		 9 μg HA 15 μg HA
    Number of subjects analysed
    66
    74
    Units: Percentage of subjects
    number (not applicable)
        Day 0 (pre-vaccination)
    0
    0
        Day 21 (post-vaccination)
    93.8
    97.3
    No statistical analyses for this end point

    Primary: Percentage of Adult Subjects Who Were Seronegative at Baseline Achieving Seroconversion or significant increase in Antibody Assayed by HAI Against A/California (H1N1) Influenza Strain After Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine

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    End point title
    		 Percentage of Adult Subjects Who Were Seronegative at Baseline Achieving Seroconversion or significant increase in Antibody Assayed by HAI Against A/California (H1N1) Influenza Strain After Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine [8]
    End point description
    Anti-hemagglutinin (HA) antibody (Ab) titers against the swine-origin A/H1N1 strain measured with the hemagglutination inhibition (HAI) method. Seroconversion was defined as subjects with a pre-vaccination titer <10 (1/dil) on Day 0, post-vaccination titer ≥40 (1/dil) and significant increase defined as subjects with a pre-vaccination titer ≥10 (1/dil), ≥four-fold increase of the titer (post/pre).
    End point type
    Primary
    End point timeframe
    Day 21 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
    		 9 μg HA 15 μg HA
    Number of subjects analysed
    64
    74
    Units: Percentage of subjects
    number (not applicable)
        Day 21/Day 0
    93.8
    97.3
    No statistical analyses for this end point

    Primary: Geometric Mean Titers (GMTs) of Antibody Assayed by HAI Method Against A/California (H1N1) Influenza Strain in Healthy Adult Subjects Who Were Seropositive at Baseline After Vaccination with Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine

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    End point title
    		 Geometric Mean Titers (GMTs) of Antibody Assayed by HAI Method Against A/California (H1N1) Influenza Strain in Healthy Adult Subjects Who Were Seropositive at Baseline After Vaccination with Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine [9]
    End point description
    Anti-hemagglutinin (HA) antibody (Ab) titers against the swine-origin A/H1N1 strain measured with the hemagglutination inhibition (HAI) method.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 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
    		 9 μg HA 15 μg HA
    Number of subjects analysed
    36
    26
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Day 0 (pre-vaccination)
    48.5 (30.2 to 77.9)
    34.5 (22.9 to 52)
        Day 21 (post-vaccination)
    1229 (846 to 1784)
    1736 (1106 to 2726)
    No statistical analyses for this end point

    Primary: Percentage of Healthy Adult Subjects Who Were Seropositive at Baseline with Detectable Antibody titers ≥10 (1/dil) Assayed by HAI Method Against A/California (H1N1) Influenza Strain After Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine

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    End point title
    		 Percentage of Healthy Adult Subjects Who Were Seropositive at Baseline with Detectable Antibody titers ≥10 (1/dil) Assayed by HAI Method Against A/California (H1N1) Influenza Strain After Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine [10]
    End point description
    Anti-hemagglutinin (HA) antibody (Ab) titers against the swine-origin A/H1N1 strain measured with the hemagglutination inhibition (HAI) method. Detectable antibody titers were defined as titers ≥10 (1/dil) on Day 0 and 21.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 post-vaccination
    Notes
    [10] - 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
    		 9 μg HA 15 μg HA
    Number of subjects analysed
    36
    26
    Units: Percentage of subjects
    number (not applicable)
        Day 0 (pre-vaccination)
    100
    100
        Day 21 (post-vaccination)
    100
    100
    No statistical analyses for this end point

    Primary: Percentage of Subjects Who Were Seropositive at Baseline with Seroprotection to A/California (H1N1) Influenza Strain Following Vaccination with Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine

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    End point title
    		 Percentage of Subjects Who Were Seropositive at Baseline with Seroprotection to A/California (H1N1) Influenza Strain Following Vaccination with Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine [11]
    End point description
    Anti-hemagglutinin (HA) antibody (Ab) titers against the swine-origin A/H1N1 strain measured with the hemagglutination inhibition (HAI) method. Seroprotection was defined as individual antibody titer ≥40 (1/dil) 21 days after vaccination.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 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.
    End point values
    		 9 μg HA 15 μg HA
    Number of subjects analysed
    36
    26
    Units: Percentage of subjects
    number (not applicable)
        Day 0 (pre-vaccination)
    55.6
    50
        Day 21 (post-vaccination)
    100
    100
    No statistical analyses for this end point

    Primary: Percentage of Adult Subjects Who Were Seropositive at Baseline Achieving Seroconversion or Significant Increase in Antibody Assayed by HAI Against A/California (H1N1) Influenza Strain After Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine

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    End point title
    		 Percentage of Adult Subjects Who Were Seropositive at Baseline Achieving Seroconversion or Significant Increase in Antibody Assayed by HAI Against A/California (H1N1) Influenza Strain After Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine [12]
    End point description
    Anti-hemagglutinin (HA) antibody (Ab) titers against the swine-origin A/H1N1 strain measured with the hemagglutination inhibition (HAI) method. Seroconversion was defined as subjects with a pre-vaccination titer <10 (1/dil) on Day 0, post-vaccination titer ≥40 (1/dil) and significant increase defined as subjects with a pre-vaccination titer ≥10 (1/dil), ≥four-fold increase of the titer (post/pre).
    End point type
    Primary
    End point timeframe
    Day 21 post-vaccination
    Notes
    [12] - 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
    		 9 μg HA 15 μg HA
    Number of subjects analysed
    34
    25
    Units: Percentage of subjects
    number (not applicable)
        Day 21/Day 0
    85.3
    96
    No statistical analyses for this end point

    Primary: Geometric Mean Titer Ratios (GMTR) of Antibody Assayed by HAI Method Against A/California (H1N1) Influenza Strain in Healthy Adult Subjects Following Vaccination with Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine

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    End point title
    		 Geometric Mean Titer Ratios (GMTR) of Antibody Assayed by HAI Method Against A/California (H1N1) Influenza Strain in Healthy Adult Subjects Following Vaccination with Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine [13]
    End point description
    Anti-hemagglutinin antibody against A/California (H1N1) Influenza Strain was assayed by the hemagglutinin inhibition assay (HAI) method. Geometric mean titer ratios were Day 21/Day 0 values.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 post-vaccination.
    Notes
    [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 9 μg HA 15 μg HA
    Number of subjects analysed
    102
    100
    Units: Titer Ratios
    geometric mean (confidence interval 95%)
        A/California (H1N1) GMTR
    50.5 (36.7 to 69.4)
    95.7 (72.4 to 127)
    No statistical analyses for this end point

    Primary: Geometric Mean Titer Ratios (GMTR) of Antibody Assayed by HAI Method Against A/California (H1N1) Influenza Strain in Healthy Seronegative Adult Age 18 to 60 Years Following Vaccination with Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine

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    End point title
    		 Geometric Mean Titer Ratios (GMTR) of Antibody Assayed by HAI Method Against A/California (H1N1) Influenza Strain in Healthy Seronegative Adult Age 18 to 60 Years Following Vaccination with Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine [14]
    End point description
    Anti-hemagglutinin antibody against A/California (H1N1) Influenza Strain was assayed by the hemagglutinin inhibition assay (HAI) method. Geometric mean titer ratios were Day 21/Day 0 values.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 post-vaccination
    Notes
    [14] - 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
    		 9 μg HA 15 μg HA
    Number of subjects analysed
    66
    74
    Units: Titer ratios
        geometric mean (confidence interval 95%)
    73.3 (51.2 to 105)
    121 (88.9 to 165)
    No statistical analyses for this end point

    Primary: Geometric Mean Titer Ratios (GMTR) of Antibody Assayed by HAI Method Against A/California (H1N1) Influenza Strain in Healthy Seropositive Adult Age 18 to 60 Years Following Vaccination with Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine

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    End point title
    		 Geometric Mean Titer Ratios (GMTR) of Antibody Assayed by HAI Method Against A/California (H1N1) Influenza Strain in Healthy Seropositive Adult Age 18 to 60 Years Following Vaccination with Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine [15]
    End point description
    Anti-hemagglutinin antibody against A/California (H1N1) Influenza Strain was assayed by the hemagglutinin inhibition assay (HAI) method. Geometric mean titer ratios were Day 21/Day 0 values.
    End point type
    Primary
    End point timeframe
    day 0 (pre-vaccination) and day 21 post-vaccination
    Notes
    [15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    		 9 μg HA 15 μg HA
    Number of subjects analysed
    36
    26
    Units: Titer ratios
    geometric mean (confidence interval 95%)
        A/California (H1N1) GMTR
    25.1 (14.1 to 44.4)
    47.8 (26.7 to 85.6)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    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
    13.0
    Reporting groups
    Reporting group title
    9 μg HA
    Reporting group description
    		 Subjects aged 18 to 60 years who received 9 μg (0.3 mL) of non-adjuvanted pandemic A/H1N1 influenza vaccine on Day 0.

    Reporting group title
    15 μg HA
    Reporting group description
    		 Subjects aged 18 to 60 years who received 15 μg (0.5 mL) of hemagglutinin (HA) of non-adjuvanted pandemic A/H1N1 influenza vaccine on Day 0.

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Solicited injection site, systemic reactions, and unsolicited adverse events were not applicable for this study.
    Serious adverse events
    		 9 μg HA 15 μg HA
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 102 (0.98%)
    2 / 100 (2.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Gastric cancer
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 9 μg HA 15 μg HA
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 100 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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