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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 Subjects Aged 3 to 17 Years

    Summary
    EudraCT number
    2009-013346-83
    Trial protocol
    FI  
    Global end of trial date
    02 Nov 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
    GPF08
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00956202
    WHO universal trial number (UTN)
    U1111-1111-4962
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur SA
    Sponsor organisation address
    2, avenue Pont Pasteur, Lyon cedex 07, France, F-69367
    Public contact
    Director, Clinical Development, Sanofi Pasteur SA, 33 4 37 37 58 50, stephanie.pepin@sanofipasteur.com
    Scientific contact
    Director, Clinical Development, Sanofi Pasteur SA, 33 4 37 37 58 50, stephanie.pepin@sanofipasteur.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    01 Apr 2011
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Nov 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 HAI and SN testing in all 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 subjects •To describe the antibody persistence eight months (M8) after the first vaccine administration using HAI method, in a subset of subjects who received two injections of either the 15 μg HA or 3.8 μg HA + AF03 vaccine (amendment 2) •To describe the immune response against the A/H1N1 strain using HAI method 21 days after a vaccination with the 2010-2011 NH seasonal TIV administered approximately 13 months after the first vaccination in the subset of subjects who received two injections of either the 15 µg HA or 3.8 µg HA + AF03 vaccine for primary vaccination series (amendment 3)
    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
    The 15 μg dose of non-adjuvanted formulation was chosen based on Sanofi Pasteur experience with seasonal influenza vaccine 15 μg (Vaxigrip®). This formulation used as safety control to the adjuvanted groups.
    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
    Finland: 303
    Worldwide total number of subjects
    303
    EEA total number of subjects
    303
    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)
    204
    Adolescents (12-17 years)
    99
    Adults (18-64 years)
    0
    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 18 August 2009 to 25 August 2009 in 15 clinical centers in Finland.

    Pre-assignment
    Screening details
    A total of 303 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
    Randomised - controlled
    Blinding used
    Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    3.8 μg HA+AF03; 9-17 years
    Arm description
    Subjects aged 9-17 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
    452
    Other name
    Pharmaceutical forms
    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; 9-17 years
    Arm description
    Subjects aged 9-17 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
    452
    Other name
    Pharmaceutical forms
    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; 9-17 years
    Arm description
    Subjects aged 9-17 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; 3-8 years
    Arm description
    Subjects aged 3-8 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
    452
    Other name
    Pharmaceutical forms
    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; 3-8 years
    Arm description
    Subjects aged 3-8 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
    452
    Other name
    Pharmaceutical forms
    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; 3-8 years
    Arm description
    Subjects aged 3-8 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; 9-17 years 7.5 μg HA+AF03; 9-17 years 15 μg HA; 9-17 years 3.8 μg HA+AF03; 3-8 years 7.5 μg HA+AF03; 3-8 years 15 μg HA; 3-8 years
    Started
    49
    50
    52
    50
    50
    52
    Completed
    49
    49
    52
    50
    49
    50
    Not completed
    0
    1
    0
    0
    1
    2
         Adverse event, non-fatal
             -
             -
             -
             -
             1
             -
         Consent withdrawn by subject
             -
             1
             -
             -
             -
             2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    3.8 μg HA+AF03; 9-17 years
    Reporting group description
    Subjects aged 9-17 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; 9-17 years
    Reporting group description
    Subjects aged 9-17 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; 9-17 years
    Reporting group description
    Subjects aged 9-17 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; 3-8 years
    Reporting group description
    Subjects aged 3-8 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; 3-8 years
    Reporting group description
    Subjects aged 3-8 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; 3-8 years
    Reporting group description
    Subjects aged 3-8 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; 9-17 years 7.5 μg HA+AF03; 9-17 years 15 μg HA; 9-17 years 3.8 μg HA+AF03; 3-8 years 7.5 μg HA+AF03; 3-8 years 15 μg HA; 3-8 years Total
    Number of subjects
    49 50 52 50 50 52 303
    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)
    16 21 15 50 50 52 204
        Adolescents (12-17 years)
    33 29 37 0 0 0 99
        Adults (18-64 years)
    0 0 0 0 0 0 0
        From 65-84 years
    0 0 0 0 0 0 0
        85 years and over
    0 0 0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    12.7 ± 2.4 12.9 ± 2.7 12.5 ± 2.3 5.6 ± 1.8 5.6 ± 1.9 6.1 ± 1.8 -
    Gender categorical
    Units: Subjects
        Female
    26 20 27 31 22 30 156
        Male
    23 30 25 19 28 22 147
    Influenza vaccination 2008/2009
    Units: Subjects
        Yes
    12 9 10 16 21 19 87
        No
    37 40 42 33 29 32 213
        Unknown
    0 1 0 1 0 1 3
    Influenza vaccination 2007/2008
    Units: Subjects
        Yes
    4 8 5 11 12 12 52
        No
    45 41 46 38 38 39 247
        Unknown
    0 1 1 1 0 1 4
    Influenza vaccination 2006/2007
    Units: Subjects
        Yes
    0 2 2 3 2 0 9
        No
    49 46 50 46 48 52 291
        Unknown
    0 2 0 1 0 0 3
    Influenza vaccination 2005/2006
    Units: Subjects
        Yes
    0 1 1 1 1 0 4
        No
    49 47 51 45 41 48 281
        Unknown
    0 2 0 1 0 0 3
        Not applicable
    0 0 0 3 8 4 15
    Influenza vaccination 2004/2005
    Units: Subjects
        Yes
    1 2 1 0 0 0 4
        No
    48 46 51 34 30 38 247
        Unknown
    0 2 0 1 0 0 3
        Not applicable
    0 0 0 15 20 14 49
    Subjects in contact with a confirmed and/or probable case of H1N1 within 8 months of enrollment
    Units: Subjects
        No
    49 46 50 49 49 51 294
        Unknown
    0 4 2 1 1 1 9

    End points

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    End points reporting groups
    Reporting group title
    3.8 μg HA+AF03; 9-17 years
    Reporting group description
    Subjects aged 9-17 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; 9-17 years
    Reporting group description
    Subjects aged 9-17 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; 9-17 years
    Reporting group description
    Subjects aged 9-17 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; 3-8 years
    Reporting group description
    Subjects aged 3-8 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; 3-8 years
    Reporting group description
    Subjects aged 3-8 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; 3-8 years
    Reporting group description
    Subjects aged 3-8 years who received two doses of A/H1N1 pandemic influenza vaccine (15 μg HA) 21 days apart.

    Primary: Geometric Mean Titers (GMTs) of Antibody Assayed by HAI Method Against A/California (H1N1) Strain in Subjects Age 9 to 17 Years Old Following 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 9 to 17 Years Old Following 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 age group specified.
    End point values
    3.8 μg HA+AF03; 9-17 years 7.5 μg HA+AF03; 9-17 years 15 μg HA; 9-17 years
    Number of subjects analysed
    49
    50
    52
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Day 0
    6.82 (5.45 to 8.54)
    8.38 (6.62 to 10.6)
    6.66 (5.24 to 8.46)
        Day 21
    1208 (915 to 1595)
    1544 (1158 to 2059)
    830 (533 to 1292)
        Day 42
    3595 (3069 to 4210)
    4476 (3957 to 5064)
    1584 (1208 to 2077)
    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 3 to 8 Years Old Following 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 3 to 8 Years Old Following 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 age group specified.
    End point values
    3.8 μg HA+AF03; 3-8 years 7.5 μg HA+AF03; 3-8 years 15 μg HA; 3-8 years
    Number of subjects analysed
    50
    50
    52
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Day 0
    5.07 (4.97 to 5.17)
    5.07 (4.93 to 5.21)
    5 (5 to 5)
        Day 21
    631 (504 to 791)
    772 (594 to 1004)
    175 (120 to 256)
        Day 42
    4476 (3791 to 5285)
    4729 (4132 to 5412)
    816 (596 to 1117)
    No statistical analyses for this end point

    Primary: Percentage of Subjects Age 9 to 17 Years Old with Antibody titers ≥ 10 (1/dil) Assayed by HAI Method Against A/California (H1N1) Strain 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 Subjects Age 9 to 17 Years Old with Antibody titers ≥ 10 (1/dil) Assayed by HAI Method Against A/California (H1N1) Strain Following 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 age group specified.
    End point values
    3.8 μg HA+AF03; 9-17 years 7.5 μg HA+AF03; 9-17 years 15 μg HA; 9-17 years
    Number of subjects analysed
    49
    50
    52
    Units: Percentage of subjects
    number (not applicable)
        Day 0
    22.9
    30.6
    11.5
        Day 21
    100
    100
    100
        Day 42
    100
    100
    100
    No statistical analyses for this end point

    Primary: Percentage of Subjects Age 3 to 8 Years Old with Antibody titers ≥ 10 (1/dil) Assayed by HAI Method Against A/California (H1N1) Strain 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 Subjects Age 3 to 8 Years Old with Antibody titers ≥ 10 (1/dil) Assayed by HAI Method Against A/California (H1N1) Strain Following 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 age group specified.
    End point values
    3.8 μg HA+AF03; 3-8 years 7.5 μg HA+AF03; 3-8 years 15 μg HA; 3-8 years
    Number of subjects analysed
    50
    50
    52
    Units: Percentage of subjects
    number (not applicable)
        Day 0
    0
    2
    0
        Day 21
    100
    100
    98
        Day 42
    100
    100
    100
    No statistical analyses for this end point

    Primary: Percentage of Subjects Age 9 to 17 Years Old with Antibody titers ≥ 40 (1/dil) Assayed by HAI Method Against A/California (H1N1) Strain 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 Subjects Age 9 to 17 Years Old with Antibody titers ≥ 40 (1/dil) Assayed by HAI Method Against A/California (H1N1) Strain 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.
    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 age group specified.
    End point values
    3.8 μg HA+AF03; 9-17 years 7.5 μg HA+AF03; 9-17 years 15 μg HA; 9-17 years
    Number of subjects analysed
    49
    50
    52
    Units: Percentage of subjects
    number (not applicable)
        Day 0
    4.2
    10.2
    7.7
        Day 21
    100
    100
    98.1
        Day 42
    100
    100
    100
    No statistical analyses for this end point

    Primary: Percentage of Subjects Age 3 to 8 Years Old with Antibody titers ≥ 40 (1/dil) Assayed by HAI Method Against A/California (H1N1) Strain 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 Subjects Age 3 to 8 Years Old with Antibody titers ≥ 40 (1/dil) Assayed by HAI Method Against A/California (H1N1) Strain 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.
    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 age group specified.
    End point values
    3.8 μg HA+AF03; 3-8 years 7.5 μg HA+AF03; 3-8 years 15 μg HA; 3-8 years
    Number of subjects analysed
    50
    50
    52
    Units: Percentage of subjects
    number (not applicable)
        Day 0
    0
    0
    0
        Day 21
    100
    100
    94
        Day 42
    100
    100
    100
    No statistical analyses for this end point

    Primary: Percentage of Subjects Age 9-17 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 9-17 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 was defined as subjects with pre-vaccination titer <10 (1/dil) on Day 0, post-vaccination titer ≥40 (1/dil). Significant increase was defined as subjects with pre-vaccination titer ≥10 (1/dil), ≥4-fold increase of the titer after vaccination (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 age group specified.
    End point values
    3.8 μg HA+AF03; 9-17 years 7.5 μg HA+AF03; 9-17 years 15 μg HA; 9-17 years
    Number of subjects analysed
    49
    50
    52
    Units: Percentage of subjects
    number (not applicable)
        Day 21
    100
    100
    98.1
        Day 42
    100
    100
    100
    No statistical analyses for this end point

    Primary: Percentage of Subjects Age 3-8 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 3-8 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 was defined as subjects with pre-vaccination titer <10 (1/dil) on Day 0, post-vaccination titer ≥40 (1/dil). Significant increase was defined as subjects with pre-vaccination titer ≥10 (1/dil), ≥4-fold increase of the titer after vaccination (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 age group specified.
    End point values
    3.8 μg HA+AF03; 3-8 years 7.5 μg HA+AF03; 3-8 years 15 μg HA; 3-8 years
    Number of subjects analysed
    50
    50
    52
    Units: Percentage of subjects
    number (not applicable)
        Day 21
    100
    100
    94
        Day 42
    100
    100
    100
    No statistical analyses for this end point

    Primary: Geometric Mean Titers (GMTs) of Neutralizing Antibody Assayed by Seroneutralization Method Against A/California (H1N1) Strain in Subjects Age 9-17 Years Old After 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 Neutralizing Antibody Assayed by Seroneutralization Method Against A/California (H1N1) Strain in Subjects Age 9-17 Years Old 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 (SN) 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 age group specified.
    End point values
    3.8 μg HA+AF03; 9-17 years 7.5 μg HA+AF03; 9-17 years 15 μg HA; 9-17 years
    Number of subjects analysed
    49
    50
    52
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Day 0
    8.12 (5.9 to 11.2)
    12.8 (8.68 to 19)
    8.14 (5.77 to 11.5)
        Day 21
    3661 (2763 to 4850)
    4492 (3534 to 5708)
    2618 (1680 to 4079)
        Day 42
    9172 (8500 to 9897)
    10109 (9910 to 10312)
    5058 (3965 to 6453)
    No statistical analyses for this end point

    Primary: Geometric Mean Titers (GMTs) of Neutralizing Antibody Assayed by Seroneutralization Method Against A/California (H1N1) Strain in Subjects Age 3-8 Years After 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 Neutralizing Antibody Assayed by Seroneutralization Method Against A/California (H1N1) Strain in Subjects Age 3-8 Years 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 (SN) 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 age group specified.
    End point values
    3.8 μg HA+AF03; 3-8 years 7.5 μg HA+AF03; 3-8 years 15 μg HA; 3-8 years
    Number of subjects analysed
    50
    50
    52
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        Day 0
    5.07 (4.93 to 5.21)
    5.12 (4.88 to 5.36)
    5.35 (4.82 to 5.94)
        Day 21
    2094 (1657 to 2646)
    2791 (2113 to 3686)
    660 (427 to 1019)
        Day 42
    9932 (9551 to 10328)
    9791 (9295 to 10314)
    2583 (1937 to 3443)
    No statistical analyses for this end point

    Primary: Percentage of Subjects Age 9-17 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 9-17 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 (SN) 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 age group specified.
    End point values
    3.8 μg HA+AF03; 9-17 years 7.5 μg HA+AF03; 9-17 years 15 μg HA; 9-17 years
    Number of subjects analysed
    49
    50
    52
    Units: Percentage of subjects
    number (not applicable)
        Day 0
    8.2
    26
    9.6
        Day 21
    100
    100
    100
        Day 42
    100
    100
    100
    No statistical analyses for this end point

    Primary: Percentage of Subjects Age 3-8 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 3-8 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 (SN) 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 age group specified.
    End point values
    3.8 μg HA+AF03; 3-8 years 7.5 μg HA+AF03; 3-8 years 15 μg HA; 3-8 years
    Number of subjects analysed
    50
    50
    52
    Units: Percentage of subjects
    number (not applicable)
        Day 0
    0
    0
    1.9
        Day 21
    100
    100
    94
        Day 42
    100
    100
    100
    No statistical analyses for this end point

    Primary: Percentage of Subjects Age 9-17 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 9-17 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 (SN) 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 age group specified.
    End point values
    3.8 μg HA+AF03; 9-17 years 7.5 μg HA+AF03; 9-17 years 15 μg HA; 9-17 years
    Number of subjects analysed
    49
    50
    52
    Units: Percentage of subjects
    number (not applicable)
        2-fold increase from Day 0; Day 21
    100
    100
    100
        2-fold increase from Day 0; Day 42
    100
    100
    100
        4-fold increase from Day 0; Day 21
    100
    100
    100
        4-fold increase from Day 0; Day 42
    100
    100
    100
    No statistical analyses for this end point

    Primary: Percentage of Subjects Age 3-8 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 3-8 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 (SN) 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 age group specified.
    End point values
    3.8 μg HA+AF03; 3-8 years 7.5 μg HA+AF03; 3-8 years 15 μg HA; 3-8 years
    Number of subjects analysed
    50
    50
    52
    Units: Percentage of subjects
    number (not applicable)
        2-fold increase from Day 0; Day 21
    100
    100
    98
        2-fold increase from Day 0; Day 42
    100
    100
    100
        4-fold increase from Day 0; Day 21
    100
    100
    96
        4-fold increase from Day 0; Day 42
    100
    100
    100
    No statistical analyses for this end point

    Primary: Geometric Mean Titers (GMTs) of Antibody Assayed by SRH Method Against A/California (H1N1) Strain in Subjects Age 9 to 17 Years Old 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 SRH Method Against A/California (H1N1) Strain in Subjects Age 9 to 17 Years Old Before and After Vaccination with 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.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and 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 age group specified.
    End point values
    3.8 μg HA+AF03; 9-17 years 7.5 μg HA+AF03; 9-17 years 15 μg HA; 9-17 years
    Number of subjects analysed
    49
    50
    52
    Units: Titers (mm2)
    geometric mean (confidence interval 95%)
        Day 0
    8.37 (6.27 to 11.2)
    12.7 (9.54 to 16.8)
    12.2 (9.24 to 16.2)
        Day 21
    95 (87.3 to 103)
    98.3 (90.2 to 107)
    94.5 (84.7 to 105)
        Day 42
    117 (113 to 121)
    118 (114 to 123)
    104 (96.5 to 112)
    No statistical analyses for this end point

    Primary: Geometric Mean Titers (GMTs) of Antibody Assayed by SRH Method Against A/California (H1N1) Strain in Subjects Age 3 to 8 Years Old 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 SRH Method Against A/California (H1N1) Strain in Subjects Age 3 to 8 Years Old Before and After Vaccination with 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.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and 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 age group specified.
    End point values
    3.8 μg HA+AF03; 3-8 years 7.5 μg HA+AF03; 3-8 years 15 μg HA; 3-8 years
    Number of subjects analysed
    50
    50
    52
    Units: Titers (mm2)
    geometric mean (confidence interval 95%)
        Day 0
    9.29 (7.43 to 11.6)
    11.9 (9.15 to 15.4)
    8.41 (6.57 to 10.8)
        Day 21
    87.1 (81.3 to 93.3)
    94.3 (88 to 101)
    64.7 (54.3 to 77.2)
        Day 42
    116 (111 to 121)
    118 (114 to 123)
    80.9 (73.1 to 89.6)
    No statistical analyses for this end point

    Primary: Percentage of Subjects Age 9-17 Years 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 9-17 Years 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 [33] [34]
    End point description
    Immunogenicity was evaluated using Single radial hemolysis (SRH) testing. Seroconversion was defined as 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
    [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 age group specified.
    End point values
    3.8 μg HA+AF03; 9-17 years 7.5 μg HA+AF03; 9-17 years 15 μg HA; 9-17 years
    Number of subjects analysed
    49
    50
    52
    Units: Percentage of subjects
    number (not applicable)
        Day 21/Day 0
    95.9
    97.9
    96.2
        Day 42/Day 0
    98
    97.9
    98.1
    No statistical analyses for this end point

    Primary: Percentage of Subjects Age 3-8 Years 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 Wi

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    End point title
    Percentage of Subjects Age 3-8 Years 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 Wi [35] [36]
    End point description
    Immunogenicity was evaluated using Single radial hemolysis (SRH) testing. Seroconversion was defined as 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
    [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 age group specified.
    End point values
    3.8 μg HA+AF03; 3-8 years 7.5 μg HA+AF03; 3-8 years 15 μg HA; 3-8 years
    Number of subjects analysed
    50
    50
    52
    Units: Percentage of subjects
    number (not applicable)
        Day 21/Day 0
    100
    100
    87.8
        Day 42/Day 0
    100
    100
    95.9
    No statistical analyses for this end point

    Primary: Percentage of Subjects Age 9 to 17 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 Subjects Age 9 to 17 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 [37] [38]
    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 (3-11 years): Pain – Incapacitating, preventing the performance of usual activities; Erythema, Swelling, Induration, and Ecchymosis - ≥5 cm. Grade 3 Solicited Injection site reactions (≥12 years): 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
    [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 age group specified.
    End point values
    3.8 μg HA+AF03; 9-17 years 7.5 μg HA+AF03; 9-17 years 15 μg HA; 9-17 years
    Number of subjects analysed
    49
    50
    52
    Units: Percentage of subjects
    number (not applicable)
        Injection site Pain
    89.8
    90
    76.9
        Grade 3 Injection site Pain
    2
    0
    0
        Injection site Erythema
    38.8
    26
    11.5
        Grade 3 Injection site Erythema
    8.2
    4
    0
        Injection site Swelling
    20.4
    14
    5.8
        Grade 3 Injection site Swelling
    2
    2
    0
        Injection site Induration
    18.4
    16
    5.8
        Grade 3 Injection site Induration
    2
    2
    0
        Injection site Ecchymosis
    6.1
    12
    3.8
        Grade 3 Injection site Ecchymosis
    0
    0
    0
        Fever
    12.2
    16
    5.8
        Grade 3 Fever
    0
    4
    3.8
        Headache
    69.4
    66
    50
        Grade 3 Headache
    4.1
    8
    3.8
        Malaise
    57.1
    50
    36.5
        Grade 3 Malaise
    10.2
    14
    3.8
        Myalgia
    49
    44
    32.7
        Grade 3 Myalgia
    4.1
    12
    1.9
        Shivering
    46.9
    40
    21.2
        Grade 3 Shivering
    2
    10
    0
    No statistical analyses for this end point

    Primary: Percentage of Subjects Age 3 to 8 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 Subjects Age 3 to 8 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 [39] [40]
    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 (3-11 years): Pain – Incapacitating, preventing the performance of usual activities; Erythema, Swelling, Induration, and Ecchymosis - ≥5 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
    [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 age group specified.
    End point values
    3.8 μg HA+AF03; 3-8 years 7.5 μg HA+AF03; 3-8 years 15 μg HA; 3-8 years
    Number of subjects analysed
    50
    50
    51
    Units: Percentage of subjects
    number (not applicable)
        Injection site Pain
    88
    74.5
    60.8
        Grade 3 Injection site Pain
    2
    2
    0
        Injection site Erythema
    50
    62.7
    23.5
        Grade 3 Injection site Erythema
    18
    19.6
    3.9
        Injection site Swelling
    28
    43.1
    7.8
        Grade 3 Injection site Swelling
    8
    7.8
    0
        Injection site Induration
    22
    27.5
    13.7
        Grade 3 Injection site Induration
    2
    0
    0
        Injection site Ecchymosis
    26
    17.6
    13.7
        Grade 3 Injection site Ecchymosis
    0
    0
    0
        Fever
    24
    23.5
    5.9
        Grade 3 Fever
    2
    3.9
    0
        Headache
    42
    43.1
    25.5
        Grade 3 Headache
    2
    7.8
    2
        Malaise
    44
    37.3
    25.5
        Grade 3 Malaise
    2
    5.9
    2
        Myalgia
    44
    33.3
    15.7
        Grade 3 Myalgia
    2
    2
    3.9
        Shivering
    28
    35.3
    15.7
        Grade 3 Shivering
    0
    2
    0
    No statistical analyses for this end point

    Primary: Percentage of Subjects Age 9-17 Years with at Least One Solicited Reactions Listed in the EMA Note for Guidance Within 3 Days After Any and 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 Subjects Age 9-17 Years with at Least One Solicited Reactions Listed in the EMA Note for Guidance Within 3 Days After Any and Each Vaccination with Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant [41] [42]
    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 and each vaccination
    Notes
    [41] - 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.
    [42] - 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 age group specified.
    End point values
    3.8 μg HA+AF03; 9-17 years 7.5 μg HA+AF03; 9-17 years 15 μg HA; 9-17 years
    Number of subjects analysed
    49
    50
    52
    Units: Percentage of subjects
    number (not applicable)
        Reaction listed in the EMA recommendation
    67.3
    56
    42.3
        Reaction listed in EMA recommendation; Post-inj. 1
    49
    42
    34.6
        Reaction listed in EMA recommendation; Post-inj. 2
    32.7
    32.7
    11.5
        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
    10.2
    14
    13.5
        Inj. site Ecchymosis; Post-inj. 1
    10.2
    14
    9.6
        Inj. site Ecchymosis; Post-inj. 2
    0
    2
    3.8
        Pyrexia (temp. >38°C) for 1 day
    8.2
    12
    3.8
        Pyrexia (temp. >38°C) for 1 day; Post-inj. 1
    4.1
    4
    1.9
        Pyrexia (temp. >38°C) for 1 day; Post-inj. 2
    4.1
    10.2
    1.9
        Malaise
    51
    44
    30.8
        Malaise; Post-inj. 1
    32.7
    26
    25
        Malaise; Post-inj. 2
    30.6
    28.6
    9.6
        Shivering
    44.9
    36
    13.5
        Shivering; Post-inj. 1
    24.5
    22
    7.7
        Shivering; Post-inj. 2
    24.5
    18.4
    5.8
    No statistical analyses for this end point

    Primary: Percentage of Subjects Age 3-8 Years with at Least One Solicited Reactions Listed in the EMA Note for Guidance Within 3 Days After Any and 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 Subjects Age 3-8 Years with at Least One Solicited Reactions Listed in the EMA Note for Guidance Within 3 Days After Any and Each Vaccination with Inactivated, Split Virion Swine-origin A/H1N1 Influenza Vaccine With or Without Adjuvant [43] [44]
    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 and each vaccination
    Notes
    [43] - 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.
    [44] - 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 age group specified.
    End point values
    3.8 μg HA+AF03; 3-8 years 7.5 μg HA+AF03; 3-8 years 15 μg HA; 3-8 years
    Number of subjects analysed
    50
    50
    51
    Units: Percentage of subjects
    number (not applicable)
        Reaction listed in the EMA recommendation
    64
    56.9
    41.2
        Reaction listed in EMA recommendation; Post-inj. 1
    36
    45.1
    29.4
        Reaction listed in EMA recommendation; Post-inj. 2
    48
    32
    20.4
        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
    24
    17.6
    11.8
        Inj. site Ecchymosis; Post-inj. 1
    14
    13.7
    5.9
        Inj. site Ecchymosis; Post-inj. 2
    12
    4
    6.1
        Pyrexia (temp. > 38°C) for 1 day
    14
    21.6
    0
        Pyrexia (temp. > 38°C) for 1 day; Post-inj. 1
    2
    11.8
    0
        Pyrexia (temp. > 38°C) for 1 day; Post-inj. 2
    12
    12
    0
        Malaise
    42
    33.3
    21.6
        Malaise; Post-inj. 1
    20
    25.5
    17.6
        Malaise; Post-inj. 2
    34
    20
    10.2
        Shivering
    28
    35.3
    13.7
        Shivering; Post-inj. 1
    16
    23.5
    9.8
        Shivering; Post-inj. 2
    16
    16
    4.1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 post-vaccination.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    12.0
    Reporting groups
    Reporting group title
    3.8 μg HA+AF03 (All groups)
    Reporting group description
    Subjects 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 (All groups)
    Reporting group description
    Subjects 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 (All groups)
    Reporting group description
    Subjects who received two doses of A/H1N1 pandemic influenza vaccine (15 μg HA) 21 days apart.

    Serious adverse events
    3.8 μg HA+AF03 (All groups) 7.5 μg HA+AF03 (All groups) 15 μg HA (All groups)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 99 (1.01%)
    2 / 101 (1.98%)
    4 / 103 (3.88%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Lower limb fracture
         subjects affected / exposed
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthritis reactive
         subjects affected / exposed
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Type 1 diabetes mellitus
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 101 (0.99%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    0 / 99 (0.00%)
    0 / 101 (0.00%)
    1 / 103 (0.97%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumococcal sepsis
         subjects affected / exposed
    1 / 99 (1.01%)
    0 / 101 (0.00%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 99 (0.00%)
    1 / 101 (0.99%)
    0 / 103 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    3.8 μg HA+AF03 (All groups) 7.5 μg HA+AF03 (All groups) 15 μg HA (All groups)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    88 / 99 (88.89%)
    83 / 101 (82.18%)
    71 / 103 (68.93%)
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    7 / 99 (7.07%)
    12 / 101 (11.88%)
    7 / 103 (6.80%)
         occurrences all number
    7
    13
    7
    Oropharyngeal pain
         subjects affected / exposed
    8 / 99 (8.08%)
    10 / 101 (9.90%)
    10 / 103 (9.71%)
         occurrences all number
    8
    11
    11
    Nervous system disorders
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    55 / 99 (55.56%)
    55 / 101 (54.46%)
    39 / 103 (37.86%)
         occurrences all number
    75
    74
    53
    General disorders and administration site conditions
    Injection site pain
    alternative assessment type: Systematic
         subjects affected / exposed
    88 / 99 (88.89%)
    83 / 101 (82.18%)
    71 / 103 (68.93%)
         occurrences all number
    149
    140
    106
    Injection site erythema
    alternative assessment type: Systematic
         subjects affected / exposed
    44 / 99 (44.44%)
    45 / 101 (44.55%)
    18 / 103 (17.48%)
         occurrences all number
    59
    63
    23
    Injection site swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    24 / 99 (24.24%)
    29 / 101 (28.71%)
    7 / 103 (6.80%)
         occurrences all number
    31
    36
    9
    Injection site ecchymosis
    alternative assessment type: Systematic
         subjects affected / exposed
    16 / 99 (16.16%)
    15 / 101 (14.85%)
    9 / 103 (8.74%)
         occurrences all number
    18
    16
    10
    Fever
    alternative assessment type: Systematic
         subjects affected / exposed
    18 / 99 (18.18%)
    20 / 101 (19.80%)
    6 / 103 (5.83%)
         occurrences all number
    18
    22
    6
    Malaise
    alternative assessment type: Systematic
         subjects affected / exposed
    50 / 99 (50.51%)
    44 / 101 (43.56%)
    32 / 103 (31.07%)
         occurrences all number
    62
    56
    40
    Shivering
    alternative assessment type: Systematic
         subjects affected / exposed
    37 / 99 (37.37%)
    38 / 101 (37.62%)
    19 / 103 (18.45%)
         occurrences all number
    43
    42
    21
    Axillary pain
         subjects affected / exposed
    0 / 99 (0.00%)
    6 / 101 (5.94%)
    1 / 103 (0.97%)
         occurrences all number
    0
    6
    1
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    2 / 99 (2.02%)
    2 / 101 (1.98%)
    6 / 103 (5.83%)
         occurrences all number
    3
    2
    6
    Skin and subcutaneous tissue disorders
    Injection site induration
    alternative assessment type: Systematic
         subjects affected / exposed
    20 / 99 (20.20%)
    22 / 101 (21.78%)
    10 / 103 (9.71%)
         occurrences all number
    25
    31
    11
    Musculoskeletal and connective tissue disorders
    Myalgia
    alternative assessment type: Systematic
         subjects affected / exposed
    46 / 99 (46.46%)
    39 / 101 (38.61%)
    25 / 103 (24.27%)
         occurrences all number
    62
    47
    33
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    4 / 99 (4.04%)
    5 / 101 (4.95%)
    12 / 103 (11.65%)
         occurrences all number
    4
    5
    14
    Respiratory tract infection
         subjects affected / exposed
    5 / 99 (5.05%)
    6 / 101 (5.94%)
    6 / 103 (5.83%)
         occurrences all number
    5
    7
    6
    Rhinitis
         subjects affected / exposed
    10 / 99 (10.10%)
    17 / 101 (16.83%)
    19 / 103 (18.45%)
         occurrences all number
    10
    21
    19
    Upper respiratory tract infection
         subjects affected / exposed
    11 / 99 (11.11%)
    11 / 101 (10.89%)
    16 / 103 (15.53%)
         occurrences all number
    13
    12
    18

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Aug 2009
    Involved changes in the ICFs of parents/guardians and subjects aged 12 to 17 years, as well as in the Assent Form, updated the population of subjects in which pregnancy tests were to be performed, i.e. to all subjects of childbearing age, and modified the modalities of physical examinations.
    01 Feb 2010
    Included modifications in order to assess antibody persistence 8 months after the first vaccine injection, by adding an additional visit (Visit 5) with an additional blood sampling.
    23 Jun 2010
    Included evaluation of the safety and immune response to the trivalent seasonal influenza vaccine 2010-2011 NH formulation on the study subjects previously vaccinated with the 3.8 μg HA + AF03 or the unadjuvanted 15 μg HA pandemic influenza vaccines. Two visits, Visit 6, planned one year after the first pandemic influenza vaccine injection and Visit 7, planned 21 days after Visit 6 were added to the protocol.

    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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