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    Clinical Trial Results:
    Evaluation of the Cellular, Humoral and Mucosal Immune Response in Adults and Elderly Subjects Vaccinated either with an Inactivated Influenza Vaccine Administered via the Intradermal Route or an Inactivated Influenza Vaccine Administered via the Intramuscular Route

    Summary
    EudraCT number
    2007-002104-18
    Trial protocol
    FR  
    Global end of trial date
    05 May 2008

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

    Trial information

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    Trial identification
    Sponsor protocol code
    GID25
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00776438
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur SA
    Sponsor organisation address
    2, avenue Pont Pasteur, F-69367 Lyon Cedex 07, France,
    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
    19 Feb 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 May 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    - To describe the cellular immune response per age group (adults or elderly) and vaccine group (Intradermal [ID] influenza or Intramuscular [IM] comparator vaccines) before vaccination and 7 days, 10 days, 14 days, 21 days, and 180 days after vaccination - To describe the humoral immune response per age group and vaccine group before vaccination, 14 days, 21 days, and 180 days after vaccination - To describe mucosal immunity per age group and vaccine group through quantification of influenza-specific IgA (total, specific and sub-classes: IgA1 and IgA2) collected from saliva and serum before vaccination and 10 days, 14 days, 21 days and 180 days after vaccination - To describe the safety of the vaccines per age group and per vaccine group after vaccination
    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
    As recommended by the WHO, the influenza vaccine (split-virion, inactivated) Vaxigrip® 2007-2008 NH formulation was used as the control product and administered by the IM route.
    Actual start date of recruitment
    17 Sep 2007
    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: 160
    Worldwide total number of subjects
    160
    EEA total number of subjects
    160
    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)
    119
    From 65 to 84 years
    41
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Study subjects were enrolled from 17 September 2007 to 09 November 2007 at 1 clinical center in France.

    Pre-assignment
    Screening details
    A total of 160 subjects who met all 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
    Randomised - controlled
    Blinding used
    Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Adult - ID 9μg
    Arm description
    Adults 18-40 years of age who received the ID influenza vaccine (split-virion, inactivated), 2007-2008 Northern Hemisphere (NH) formulation (9 μg).
    Arm type
    Experimental

    Investigational medicinal product name
    Intradermal Influenza Vaccine
    Investigational medicinal product code
    333
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    0.1 mL dose (9 μg strength), intradermal use into the upper arm (deltoid area), one dose on V01.

    Arm title
    Adult - IM 15μg
    Arm description
    Adults 18-40 years of age who received the IM influenza vaccine (split-virion, inactivated), 2007-2008 NH formulation (Vaxigrip®; 15 μg).
    Arm type
    Active comparator

    Investigational medicinal product name
    Vaxigrip®
    Investigational medicinal product code
    Other name
    Inactivated, split-virion, influenza virus (H3N2 strain)
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL dose (15 μg strength), intramuscular use into the upper arm (deltoid area), one dose on Day 0.

    Arm title
    Elderly - ID 15μg
    Arm description
    Elderly subjects 60-85 years of age who received the ID influenza vaccine (split-virion, inactivated), 2007-2008 Northern Hemisphere (NH) formulation (15 μg).
    Arm type
    Experimental

    Investigational medicinal product name
    Intradermal Influenza Vaccine
    Investigational medicinal product code
    333
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    0.1 mL dose (15 μg strength), intradermal use into the upper arm (deltoid area), one dose on Day 0.

    Arm title
    Elderly - IM 15μg
    Arm description
    Elderly subjects 60-85 years of age who received the IM influenza vaccine (split-virion, inactivated), 2007-2008 NH formulation (Vaxigrip®; 15 μg).
    Arm type
    Active comparator

    Investigational medicinal product name
    Vaxigrip®
    Investigational medicinal product code
    Other name
    Inactivated, split-virion, influenza virus (H3N2 strain)
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL dose (15 μg strength), intramuscular use into the upper arm (deltoid area), one dose on Day 0.

    Number of subjects in period 1
    Adult - ID 9μg Adult - IM 15μg Elderly - ID 15μg Elderly - IM 15μg
    Started
    38
    42
    40
    40
    Completed
    35
    41
    39
    40
    Not completed
    3
    1
    1
    0
         Protocol deviation
             1
             -
             -
             -
         Consent withdrawn by subject
             1
             1
             1
             -
         Lost to follow-up
             1
             -
             -
             -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Adult - ID 9μg
    Reporting group description
    Adults 18-40 years of age who received the ID influenza vaccine (split-virion, inactivated), 2007-2008 Northern Hemisphere (NH) formulation (9 μg).

    Reporting group title
    Adult - IM 15μg
    Reporting group description
    Adults 18-40 years of age who received the IM influenza vaccine (split-virion, inactivated), 2007-2008 NH formulation (Vaxigrip®; 15 μg).

    Reporting group title
    Elderly - ID 15μg
    Reporting group description
    Elderly subjects 60-85 years of age who received the ID influenza vaccine (split-virion, inactivated), 2007-2008 Northern Hemisphere (NH) formulation (15 μg).

    Reporting group title
    Elderly - IM 15μg
    Reporting group description
    Elderly subjects 60-85 years of age who received the IM influenza vaccine (split-virion, inactivated), 2007-2008 NH formulation (Vaxigrip®; 15 μg).

    Reporting group values
    Adult - ID 9μg Adult - IM 15μg Elderly - ID 15μg Elderly - IM 15μg Total
    Number of subjects
    38 42 40 40 160
    Age categorical
    Units: Subjects
        In utero
    0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0 0
        Newborns (0-27 days)
    0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0 0
        Children (2-11 years)
    0 0 0 0 0
        Adolescents (12-17 years)
    0 0 0 0 0
        Adults (18-64 years)
    38 42 19 20 119
        From 65-84 years
    0 0 21 20 41
        85 years and over
    0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    26.6 ± 5.7 25.7 ± 4.8 65.7 ± 5 65.9 ± 4 -
    Gender categorical
    Units: Subjects
        Female
    26 30 17 22 95
        Male
    12 12 23 18 65

    End points

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    End points reporting groups
    Reporting group title
    Adult - ID 9μg
    Reporting group description
    Adults 18-40 years of age who received the ID influenza vaccine (split-virion, inactivated), 2007-2008 Northern Hemisphere (NH) formulation (9 μg).

    Reporting group title
    Adult - IM 15μg
    Reporting group description
    Adults 18-40 years of age who received the IM influenza vaccine (split-virion, inactivated), 2007-2008 NH formulation (Vaxigrip®; 15 μg).

    Reporting group title
    Elderly - ID 15μg
    Reporting group description
    Elderly subjects 60-85 years of age who received the ID influenza vaccine (split-virion, inactivated), 2007-2008 Northern Hemisphere (NH) formulation (15 μg).

    Reporting group title
    Elderly - IM 15μg
    Reporting group description
    Elderly subjects 60-85 years of age who received the IM influenza vaccine (split-virion, inactivated), 2007-2008 NH formulation (Vaxigrip®; 15 μg).

    Primary: Median Percentage of IFN-γ and TNF-α Single Secreting CD4 T Cells Specific for each of the Influenza Vaccine Strains Before Vaccination in Adults and Elderly Subjects Randomized to Either Intradermal or Intramuscular Route

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    End point title
    Median Percentage of IFN-γ and TNF-α Single Secreting CD4 T Cells Specific for each of the Influenza Vaccine Strains Before Vaccination in Adults and Elderly Subjects Randomized to Either Intradermal or Intramuscular Route [1]
    End point description
    Cellular immune response was assessed using the intracellular cytokine staining (ICS) method.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-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
    Adult - ID 9μg Adult - IM 15μg Elderly - ID 15μg Elderly - IM 15μg
    Number of subjects analysed
    38
    42
    40
    40
    Units: Median percentage of CD4 T cells
    number (not applicable)
        A/H1N1 Solomon Island; IFN-γ+
    0.135
    0.1
    0.05
    0.05
        A/H3N2 Wisconsin; IFN-γ+
    0.315
    0.34
    0.185
    0.13
        B/Malaysia; IFN-γ+
    0.51
    0.5
    0.17
    0.16
        A/H1N1 Solomon Island; TNF-α+
    0.18
    0.14
    0.14
    0.07
        A/H3N2 Wisconsin; TNF-α+
    0.114
    0.155
    0.095
    0.06
        B/Malaysia; TNF-α+
    0.2
    0.18
    0.14
    0.13
        A/H1N1 Solomon Island; IL-2+
    0.06
    0.05
    0.05
    0.02
        A/H3N2 Wisconsin; IL-2+
    0.03
    0.02
    0.02
    0.01
        B/Malaysia; IL-2+
    0.085
    0.06
    0.07
    0.03
        A/H1N1 Solomon Island; IFN-γ+/IL-2+
    0.035
    0.027
    0.015
    0.007
        A/H3N2 Wisconsin; IFN-γ+/IL-2+
    0.015
    0.01
    0.01
    0.005
        B/Malaysia; IFN-γ+/IL-2+
    0.045
    0.035
    0.025
    0.02
        A/H1N1 Solomon Island; TNF-α+/IL-2+
    0.035
    0.03
    0.027
    0.02
        A/H3N2 Wisconsin; TNF-α+/IL-2+
    0.012
    0.01
    0.01
    0.01
        B/Malaysia; TNF-α+/IL-2+
    0.05
    0.042
    0.04
    0.025
        A/H1N1 Solomon Island; IFN-γ+/TNF-α+
    0.04
    0.032
    0.015
    0.012
        A/H3N2 Wisconsin; IFN-γ+/TNF-α+
    0.035
    0.035
    0.015
    0.007
        B/Malaysia; IFN-γ+/TNF-α+
    0.075
    0.055
    0.03
    0.03
        A/H1N1 Solomon Island; IFN-γ+/TNF-α+/IL-2+
    0.025
    0.022
    0.012
    0.005
        A/H3N2 Wisconsin; IFN-γ+/TNF-α+/IL-2+
    0.005
    0.005
    0.005
    0.005
        B/Malaysia; IFN-γ+/TNF-α+/IL-2+
    0.035
    0.025
    0.015
    0.012
    No statistical analyses for this end point

    Primary: Geometric Mean Ratios of Cytokine Secreting CD8 T Cell in Adults and Elderly Subjects Vaccinated with an Inactivated Influenza Vaccine Administered By Either Intradermal or Intramuscular Route

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    End point title
    Geometric Mean Ratios of Cytokine Secreting CD8 T Cell in Adults and Elderly Subjects Vaccinated with an Inactivated Influenza Vaccine Administered By Either Intradermal or Intramuscular Route [2]
    End point description
    Cellular immune response was assessed using the intracellular cytokine staining (ICS) method.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 7, 10, 14, 21, and 180 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
    Adult - ID 9μg Adult - IM 15μg Elderly - ID 15μg Elderly - IM 15μg
    Number of subjects analysed
    38
    42
    40
    40
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        IFN-γ+; A/H1N1 Solomon Island (D7/D0)
    0.771 (0.614 to 0.967)
    1.04 (0.772 to 1.39)
    1.22 (0.885 to 1.68)
    1.57 (0.958 to 2.58)
        IFN-γ+; A/H3N2 Wisconsin (D7/D0)
    0.722 (0.555 to 0.939)
    0.842 (0.621 to 1.14)
    0.737 (0.469 to 1.16)
    1.24 (0.873 to 1.76)
        IFN-γ+; B/Malaysia (D7/D0)
    0.974 (0.763 to 1.24)
    1.04 (0.749 to 1.46)
    1.1 (0.877 to 1.38)
    1.55 (0.766 to 3.14)
        IFN-γ+; A/H1N1 Solomon Island (D10/D0)
    0.906 (0.705 to 1.16)
    0.843 (0.615 to 1.16)
    1.13 (0.816 to 1.57)
    1.11 (0.73 to 1.69)
        IFN-γ+; A/H3N2 Wisconsin (D10/D0)
    0.736 (0.541 to 1)
    0.893 (0.673 to 1.18)
    0.818 (0.642 to 1.04)
    1.18 (0.875 to 1.59)
        IFN-γ+; B/Malaysia (D10/D0)
    0.948 (0.682 to 1.32)
    1.18 (0.879 to 1.59)
    0.875 (0.603 to 1.27)
    1.33 (0.859 to 2.07)
        IFN-γ+; A/H1N1 Solomon Island (D14/D0)
    0.969 (0.714 to 1.31)
    1.15 (0.881 to 1.5)
    1.16 (0.872 to 1.54)
    1.23 (0.867 to 1.75)
        IFN-γ+; A/H3N2 Wisconsin (D14/D0)
    0.82 (0.635 to 1.06)
    0.968 (0.724 to 1.29)
    0.72 (0.489 to 1.06)
    1.23 (0.927 to 1.64)
        IFN-γ+; B/Malaysia (D14/D0)
    0.956 (0.702 to 1.3)
    1.24 (0.918 to 1.68)
    0.691 (0.463 to 1.03)
    1.11 (0.68 to 1.8)
        IFN-γ+; A/H1N1 Solomon Island (D21/D0)
    0.916 (0.737 to 1.14)
    1.05 (0.746 to 1.47)
    0.977 (0.76 to 1.26)
    1.2 (0.721 to 1.98)
        IFN-γ+; A/H3N2 Wisconsin (D21/D0)
    0.949 (0.806 to 1)
    0.99 (0.739 to 1.33)
    1.13 (0.874 to 1.45)
    1.14 (0.783 to 1.67)
        IFN-γ+; B/Malaysia (D21/D0)
    1.01 (0.763 to 1.34)
    1.24 (0.921 to 1.66)
    1.11 (0.711 to 1.73)
    1.12 (0.639 to 1.95)
        IFN-γ+; A/H1N1 Solomon Island (D180/D0)
    0.963 (0.608 to 1.53)
    1.13 (0.791 to 1.62)
    0.913 (0.503 to 1.66)
    1.47 (0.919 to 2.35)
        IFN-γ+; A/H3N2 Wisconsin (D180/D0)
    1.48 (1.12 to 1.95)
    1.28 (0.89 to 1.83)
    0.998 (0.644 to 1.55)
    2 (1.47 to 2.74)
        IFN-γ+; B/Malaysia (D180/D0)
    1.19 (0.847 to 1.67)
    1.28 (0.909 to 1.8)
    1.03 (0.722 to 1.46)
    1.94 (1.01 to 3.7)
        TNF-α+; A/H1N1 Solomon Island (D7/D0)
    0.869 (0.664 to 1.14)
    1.01 (0.753 to 1.35)
    1.2 (0.866 to 1.68)
    1.66 (0.821 to 3.35)
        TNF-α+; A/H3N2 Wisconsin (D7/D0)
    1.02 (0.666 to 1.55)
    1.03 (0.633 to 1.66)
    1.09 (0.57 to 2.09)
    1.36 (0.717 to 2.57)
        TNF-α+; B/Malaysia (D7/D0)
    1.08 (0.702 to 1.67)
    1.01 (0.68 to 1.5)
    0.84 (0.483 to 1.46)
    1.21 (0.627 to 2.35)
        TNF-α+; A/H1N1 Solomon Island (D10/D0)
    1.07 (0.83 to 1.37)
    0.835 (0.616 to 1.13)
    0.917 (0.725 to 1.16)
    0.972 (0.598 to 1.58)
        TNF-α+; A/H3N2 Wisconsin (D10/D0)
    0.82 (0.49 to 1.37)
    1.08 (0.714 to 1.63)
    1.19 (0.83 to 1.72)
    1.1 (0.635 to 1.9)
        TNF-α+; B/Malaysia (D10/D0)
    0.948 (0.58 to 1.55)
    1.26 (0.879 to 1.79)
    1.15 (0.735 to 1.8)
    1.05 (0.776 to 1.43)
        TNF-α+; A/H1N1 Solomon Island (D14/D0)
    0.869 (0.591 to 1.28)
    1.09 (0.858 to 1.38)
    1.24 (0.685 to 2.24)
    1.49 (0.935 to 2.37)
        TNF-α+; A/H3N2 Wisconsin (D14/D0)
    0.908 (0.557 to 1.48)
    1.12 (0.816 to 1.55)
    0.972 (0.536 to 1.76)
    1.01 (0.583 to 1.76)
        TNF-α+; B/Malaysia (D14/D0)
    1 (0.63 to 1.6)
    1.3 (0.913 to 1.86)
    0.86 (0.566 to 1.31)
    1.06 (0.786 to 1.43)
        TNF-α+; A/H1N1 Solomon Island (D21/D0)
    0.953 (0.708 to 1.28)
    0.972 (0.747 to 1.27)
    1.01 (0.716 to 1.44)
    0.843 (0.522 to 1.36)
        TNF-α+; A/H3N2 Wisconsin (D21/D0)
    1.04 (0.622 to 1.74)
    0.902 (0.584 to 1.39)
    0.983 (0.601 to 1.61)
    1.13 (0.647 to 1.98)
        TNF-α+; B/Malaysia (D21/D0)
    1.03 (0.648 to 1.64)
    1.17 (0.761 to 1.8)
    1.21 (0.69 to 2.13)
    1.28 (0.853 to 1.92)
        TNF-α+; A/H1N1 Solomon Island (D180/D0)
    0.774 (0.466 to 1.29)
    1.09 (0.792 to 1.5)
    1.2 (0.688 to 2.09)
    1.26 (0.805 to 1.98)
        TNF-α+; A/H3N2 Wisconsin (D180/D0)
    1.21 (0.627 to 2.34)
    1.23 (0.732 to 2.07)
    1.04 (0.599 to 1.79)
    1.19 (0.673 to 2.1)
        TNF-α+; B/Malaysia (D180/D0)
    0.944 (0.521 to 1.71)
    1.23 (0.767 to 1.97)
    1.13 (0.722 to 1.76)
    1.71 (1.03 to 2.85)
        IL-2+; A/H1N1 Solomon Island (D7/D0)
    0.809 (0.648 to 1.01)
    0.803 (0.583 to 1.11)
    1.31 (0.957 to 1.78)
    1.28 (0.763 to 2.15)
        IL-2+; A/H3N2 Wisconsin (D7/D0)
    0.9 (0.633 to 1.28)
    1.1 (0.694 to 1.75)
    1.17 (0.627 to 2.2)
    1.41 (0.754 to 2.62)
        IL-2+; B/Malaysia (D7/D0)
    0.705 (0.542 to 0.918)
    1.12 (0.802 to 1.55)
    0.824 (0.545 to 1.24)
    0.803 (0.552 to 1.17)
        IL-2+; A/H1N1 Solomon Island (D10/D0)
    0.706 (0.487 to 1.02)
    0.973 (0.704 to 1.35)
    1.11 (0.809 to 1.54)
    1.07 (0.584 to 1.94)
        IL-2+; A/H3N2 Wisconsin (D10/D0)
    0.733 (0.478 to 1.13)
    1.23 (0.854 to 1.78)
    0.731 (0.479 to 1.12)
    0.987 (0.592 to 1.64)
        IL-2+; B/Malaysia (D10/D0)
    0.648 (0.435 to 0.965)
    1.22 (0.815 to 1.82)
    1.02 (0.657 to 1.58)
    0.881 (0.6 to 1.29)
        IL-2+; A/H1N1 Solomon Island (D14/D0)
    0.811 (0.575 to 1.14)
    1.12 (0.774 to 1.63)
    1.02 (0.709 to 1.47)
    1.66 (1.06 to 2.62)
        IL-2+; A/H3N2 Wisconsin (D14/D0)
    0.757 (0.521 to 1.1)
    1.03 (0.637 to 1.66)
    0.816 (0.428 to 1.55)
    1.45 (0.943 to 2.22)
        IL-2+; B/Malaysia (D14/D0)
    0.638 (0.393 to 1.04)
    1.43 (0.99 to 2.06)
    0.936 (0.637 to 1.37)
    0.993 (0.756 to 1.3)
        IL-2+; A/H1N1 Solomon Island (D21/D0)
    0.819 (0.614 to 1.09)
    0.93 (0.619 to 1.4)
    0.815 (0.508 to 1.31)
    1.17 (0.768 to 1.79)
        IL-2+; A/H3N2 Wisconsin (D21/D0)
    0.837 (0.528 to 1.33)
    1.04 (0.597 to 1.81)
    0.764 (0.529 to 1.1)
    1.4 (0.812 to 2.41)
        IL-2+; B/Malaysia (D21/D0)
    0.808 (0.589 to 1.11)
    1.31 (0.812 to 2.1)
    0.634 (0.319 to 1.26)
    1.29 (0.911 to 1.83)
        IL-2+; A/H1N1 Solomon Island (D180/D0)
    0.741 (0.512 to 1.07)
    1.2 (0.809 to 1.79)
    1.05 (0.69 to 1.61)
    1.81 (1.22 to 2.68)
        IL-2+; A/H3N2 Wisconsin (D180/D0)
    0.801 (0.418 to 1.53)
    1.76 (0.958 to 3.24)
    0.512 (0.198 to 1.32)
    2.14 (1.2 to 3.81)
        IL-2+; B/Malaysia (D180/D0)
    0.671 (0.455 to 0.988)
    1.65 (1.01 to 2.68)
    0.945 (0.558 to 1.6)
    1.77 (1.17 to 2.68)
    No statistical analyses for this end point

    Primary: Summary of Anti-HA Lymphoproliferative Response in terms of Geometric Mean of Counts per minute and Stimulation Index in Adults and Elderly Subjects Vaccinated with an Inactivated Influenza Vaccine Administered By Intradermal or Intramuscular Route

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    End point title
    Summary of Anti-HA Lymphoproliferative Response in terms of Geometric Mean of Counts per minute and Stimulation Index in Adults and Elderly Subjects Vaccinated with an Inactivated Influenza Vaccine Administered By Intradermal or Intramuscular Route [3]
    End point description
    Corrected lymphoproliferation (cpm) and stimulation index (SI) were assessed using the lymphoproliferation method with H1N1/Solomon Island rHA protein.
    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
    Adult - ID 9μg Adult - IM 15μg Elderly - ID 15μg Elderly - IM 15μg
    Number of subjects analysed
    38
    42
    40
    40
    Units: Counts per minute and Stimulation index
    geometric mean (confidence interval 95%)
        Corrected lymphoproliferation (cpm); D0
    9433 (6569 to 13545)
    10250 (7836 to 13408)
    6171 (4635 to 8217)
    4603 (3639 to 5822)
        Stimulation index (SI); D0
    5.81 (4.5 to 7.5)
    4.3 (3.48 to 5.33)
    3.66 (3.06 to 4.38)
    3.11 (2.67 to 3.62)
        Corrected lymphoproliferation (cpm); D21
    12822 (8576 to 19170)
    17070 (13582 to 21452)
    10402 (7347 to 14729)
    8816 (6171 to 12595)
        Stimulation index (SI); D21
    6.52 (4.92 to 8.63)
    5.92 (4.76 to 7.36)
    5.17 (4.21 to 6.35)
    4.79 (3.73 to 6.15)
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Stimulation index (SI) Titers ≥3 and corrected lymphoproliferation ≥3000 Counts per minute in Adults and Elderly Subjects Vaccinated with an Inactivated Influenza Vaccine Administered By Intradermal or Intramuscular Route

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    End point title
    Percentage of Subjects with Stimulation index (SI) Titers ≥3 and corrected lymphoproliferation ≥3000 Counts per minute in Adults and Elderly Subjects Vaccinated with an Inactivated Influenza Vaccine Administered By Intradermal or Intramuscular Route [4]
    End point description
    Stimulation index (SI) ≥3 and corrected lymphoproliferation (cpm) were assessed using the lymphoproliferation method with H1N1/Solomon Island rHA protein.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 post-vaccination
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    Adult - ID 9μg Adult - IM 15μg Elderly - ID 15μg Elderly - IM 15μg
    Number of subjects analysed
    38
    42
    40
    40
    Units: Percentage of subjects
    number (not applicable)
        SI ≥3, corrected lymphoproliferation;D0;≥3000 cpm
    76.7
    63.2
    55.6
    41.7
        SI ≥3, corrected lymphoproliferation;D21;≥3000 cpm
    75.9
    86.8
    82.9
    69.4
    No statistical analyses for this end point

    Primary: Geometric Mean Titers of HI Antibody Response to the Three Influenza Strains in Adults and Elderly Subjects Vaccinated with an Inactivated Influenza Vaccine Administered By Intradermal or Intramuscular Route

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    End point title
    Geometric Mean Titers of HI Antibody Response to the Three Influenza Strains in Adults and Elderly Subjects Vaccinated with an Inactivated Influenza Vaccine Administered By Intradermal or Intramuscular Route [5]
    End point description
    The humoral immune response was assessed using the hemagglutination inhibition (HI) test.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 14, 21, and 180 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
    Adult - ID 9μg Adult - IM 15μg Elderly - ID 15μg Elderly - IM 15μg
    Number of subjects analysed
    38
    42
    40
    40
    Units: Titer (1/dil)
    geometric mean (confidence interval 95%)
        A/Solomon Island/3/2006 (H1N1); D0
    31.8 (16.5 to 61.6)
    48 (27.1 to 85)
    10.3 (7.18 to 14.7)
    8.41 (6.53 to 10.8)
        A/Solomon Island/3/2006 (H1N1); D14
    840 (487 to 1449)
    742 (491 to 1123)
    232 (155 to 349)
    143 (86.5 to 236)
        A/Solomon Island/3/2006 (H1N1); D21
    622 (373 to 1037)
    580 (377 to 892)
    230 (152 to 350)
    148 (90.5 to 242)
        A/Solomon Island/3/2006 (H1N1); D180
    245 (159 to 377)
    219 (150 to 320)
    65.8 (45.8 to 94.5)
    46.3 (28.8 to 74.5)
        A/Wisconsin/67/2005 (H3N2); D0
    59.2 (34.8 to 101)
    54.7 (33.2 to 90.1)
    33.3 (18.1 to 61.5)
    29.5 (18.1 to 48.3)
        A/Wisconsin/67/2005 (H3N2); D14
    516 (365 to 728)
    496 (356 to 690)
    634 (420 to 957)
    469 (308 to 713)
        A/Wisconsin/67/2005 (H3N2); D21
    488 (341 to 699)
    468 (326 to 671)
    663 (444 to 991)
    511 (336 to 778)
        A/Wisconsin/67/2005 (H3N2); D180
    215 (144 to 321)
    183 (132 to 255)
    159 (106 to 236)
    139 (96.7 to 201)
        B/Malaysia/2506/2004; D0
    12.9 (9.01 to 18.5)
    18.7 (13.1 to 26.7)
    10.9 (8.41 to 14.1)
    8.56 (6.57 to 11.1)
        B/Malaysia/2506/2004; D14
    91.2 (64.6 to 129)
    181 (129 to 255)
    75.8 (47.6 to 121)
    41.8 (26.8 to 65.1)
        B/Malaysia/2506/2004; D21
    78.5 (54.5 to 113)
    156 (114 to 214)
    74.5 (46.6 to 119)
    38.6 (25.4 to 58.9)
        B/Malaysia/2506/2004; D180
    22.3 (14.8 to 33.6)
    39.7 (28.7 to 54.8)
    16.3 (11 to 24.2)
    12.9 (9.42 to 17.6)
    No statistical analyses for this end point

    Primary: Geometric Mean Titers Ratios of HI Antibody Response to the Three Influenza Strains in Adults and Elderly Subjects Vaccinated with an Inactivated Influenza Vaccine Administered By Intradermal or Intramuscular Route

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    End point title
    Geometric Mean Titers Ratios of HI Antibody Response to the Three Influenza Strains in Adults and Elderly Subjects Vaccinated with an Inactivated Influenza Vaccine Administered By Intradermal or Intramuscular Route [6]
    End point description
    The humoral immune response was assessed using the hemagglutination inhibition (HI) test.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 14, 21, and 180 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
    Adult - ID 9μg Adult - IM 15μg Elderly - ID 15μg Elderly - IM 15μg
    Number of subjects analysed
    38
    42
    40
    40
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        A/Solomon Island/3/2006 (H1N1); D14/D0
    25.1 (11.5 to 54.9)
    15.5 (7.86 to 30.5)
    22.2 (14.6 to 33.9)
    17 (10.6 to 27.2)
        A/Solomon Island/3/2006 (H1N1); D21/D0
    18.6 (8.87 to 39)
    12.1 (6.16 to 23.7)
    22 (14.8 to 32.7)
    17.6 (11 to 28.2)
        A/Solomon Island/3/2006 (H1N1); D180/D0
    7.61 (3.98 to 14.6)
    4.39 (2.41 to 8.01)
    6.7 (4.52 to 9.92)
    5.51 (3.47 to 8.75)
        A/Wisconsin/67/2005 (H3N2); D14/D0
    8.7 (4.88 to 15.5)
    9.05 (5.28 to 15.5)
    18.8 (9.21 to 38.3)
    15.9 (8.36 to 30.1)
        A/Wisconsin/67/2005 (H3N2); D21/D0
    8.23 (4.85 to 14)
    8.55 (4.71 to 15.5)
    19.6 (9.74 to 39.6)
    17.3 (9.6 to 31.2)
        A/Wisconsin/67/2005 (H3N2); D180/D0
    3.84 (2.36 to 6.26)
    3.16 (1.95 to 5.12)
    5 (2.77 to 9)
    4.72 (2.84 to 7.84)
        B/Malaysia/2506/2004; D14/D0
    7.28 (4.77 to 11.1)
    9.67 (5.6 to 16.7)
    6.82 (4.29 to 10.8)
    4.88 (3.32 to 7.17)
        B/Malaysia/2506/2004; D21/D0
    6.27 (4.11 to 9.58)
    8.34 (5 to 13.9)
    6.7 (4.26 to 10.5)
    4.52 (3.22 to 6.33)
        B/Malaysia/2506/2004; D180/D0
    1.79 (1.19 to 2.7)
    2.14 (1.37 to 3.34)
    1.56 (1.08 to 2.25)
    1.5 (1.25 to 1.81)
    No statistical analyses for this end point

    Primary: Percentage of Subjects with HI Antibody Titers ≥10 (1/dil) and ≥40 (1/dil) of HI Antibody Response to the Three Influenza Strains in Adults and Elderly Subjects Vaccinated with an Inactivated Influenza Vaccine, Intradermal or Intramuscular Route

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    End point title
    Percentage of Subjects with HI Antibody Titers ≥10 (1/dil) and ≥40 (1/dil) of HI Antibody Response to the Three Influenza Strains in Adults and Elderly Subjects Vaccinated with an Inactivated Influenza Vaccine, Intradermal or Intramuscular Route [7]
    End point description
    The humoral immune response was assessed using the hemagglutination inhibition (HI) test.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 14, 21, and 180 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
    Adult - ID 9μg Adult - IM 15μg Elderly - ID 15μg Elderly - IM 15μg
    Number of subjects analysed
    38
    42
    40
    40
    Units: Percentage of subjects
    number (not applicable)
        A/Solomon Island/3/2006 (H1N1); ≥10 (1/dil); D0
    65.8
    76.2
    35
    30
        A/Solomon Island/3/2006 (H1N1); ≥10 (1/dil); D14
    97.3
    100
    100
    97.5
        A/Solomon Island/3/2006 (H1N1); ≥10 (1/dil); D21
    100
    100
    100
    97.5
        A/Solomon Island/3/2006 (H1N1); ≥10 (1/dil); D180
    100
    100
    100
    87.5
        A/Wisconsin/67/2005 (H3N2); ≥10 (1/dil); D0
    89.5
    81
    60
    70
        A/Wisconsin/67/2005 (H3N2); ≥10 (1/dil); D14
    100
    100
    100
    100
        A/Wisconsin/67/2005 (H3N2); ≥10 (1/dil); D21
    100
    100
    100
    100
        A/Wisconsin/67/2005 (H3N2); ≥10 (1/dil); D180
    100
    100
    97.4
    100
        B/Malaysia/2506/2004; ≥10 (1/dil); D0
    52.6
    71.4
    60
    32.5
        B/Malaysia/2506/2004; ≥10 (1/dil); D14
    100
    100
    97.4
    90
        B/Malaysia/2506/2004; ≥10 (1/dil); D21
    97.3
    100
    94.9
    87.5
        B/Malaysia/2506/2004; ≥10 (1/dil); D180
    77.1
    90.2
    53.8
    52.5
        A/Solomon Island/3/2006 (H1N1); ≥40 (1/dil); D0
    36.8
    50
    15
    5
        A/Solomon Island/3/2006 (H1N1); ≥40 (1/dil); D14
    97.3
    97.6
    94.9
    72.5
        A/Solomon Island/3/2006 (H1N1); ≥40 (1/dil); D21
    94.6
    97.6
    92.3
    77.5
        A/Solomon Island/3/2006 (H1N1); ≥40 (1/dil); D180
    94.3
    90.2
    71.8
    55
        A/Wisconsin/67/2005 (H3N2); ≥40 (1/dil); D0
    57.9
    61.9
    42.5
    45
        A/Wisconsin/67/2005 (H3N2); ≥40 (1/dil); D14
    100
    97.6
    97.4
    97.5
        A/Wisconsin/67/2005 (H3N2); ≥40 (1/dil); D21
    100
    97.6
    100
    97.5
        A/Wisconsin/67/2005 (H3N2); ≥40 (1/dil); D180
    94.3
    92.7
    92.3
    87.5
        B/Malaysia/2506/2004; ≥40 (1/dil); D0
    15.8
    31
    10
    7.5
        B/Malaysia/2506/2004; ≥40 (1/dil); D14
    75.7
    95.2
    69.2
    55
        B/Malaysia/2506/2004; ≥40 (1/dil); D21
    75.7
    95.2
    69.2
    57.5
        B/Malaysia/2506/2004; ≥40 (1/dil); D180
    37.1
    56.1
    25.6
    17.5
    No statistical analyses for this end point

    Primary: Percentage of Subjects Achieving Seroconversion or significant increase in HI Antibody Titers to the Three Influenza Strains in Adults and Elderly Subjects Vaccinated with an Inactivated Influenza Vaccine, Intradermal or Intramuscular Route

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    End point title
    Percentage of Subjects Achieving Seroconversion or significant increase in HI Antibody Titers to the Three Influenza Strains in Adults and Elderly Subjects Vaccinated with an Inactivated Influenza Vaccine, Intradermal or Intramuscular Route [8]
    End point description
    The humoral immune response was assessed using the hemagglutination inhibition (HI) test. Seroconversion was defined as subjects with pre-vaccination titer <10 (1/dil) and with a post-vaccination titer ≥40 (1/dil) or significant increase was subjects with pre-vaccination titer ≥10 (1/dil) and with at least a 4-fold increase in post-vaccination titer.
    End point type
    Primary
    End point timeframe
    Day 14, 21, and 180 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
    Adult - ID 9μg Adult - IM 15μg Elderly - ID 15μg Elderly - IM 15μg
    Number of subjects analysed
    38
    42
    40
    40
    Units: Percentage of subjects
    number (not applicable)
        A/Solomon Island/3/2006 (H1N1); % from D0 to D14
    67.6
    69
    89.7
    70
        A/Solomon Island/3/2006 (H1N1); % from D0 to D21
    64.9
    64.3
    89.7
    75
        A/Solomon Island/3/2006 (H1N1); % from D0 to D180
    62.9
    53.7
    61.5
    47.5
        A/Wisconsin/67/2005 (H3N2); % from D0 to D14
    64.9
    61.9
    74.4
    70
        A/Wisconsin/67/2005 (H3N2); % from D0 to D21
    64.9
    59.5
    74.4
    77.5
        A/Wisconsin/67/2005 (H3N2); % from D0 to D180
    48.6
    36.6
    53.8
    47.5
        B/Malaysia/2506/2004; % from D0 to D14
    62.2
    61.9
    53.8
    47.5
        B/Malaysia/2506/2004; % from D0 to D21
    62.2
    59.5
    59
    50
        B/Malaysia/2506/2004; % from D0 to D180
    22.9
    31.7
    23.1
    10
    No statistical analyses for this end point

    Primary: Geometric Mean Titers of Total IgA in Saliva of Adults and Elderly Subjects Vaccinated with an Inactivated Influenza Vaccine Administered By Intradermal or Intramuscular Route

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    End point title
    Geometric Mean Titers of Total IgA in Saliva of Adults and Elderly Subjects Vaccinated with an Inactivated Influenza Vaccine Administered By Intradermal or Intramuscular Route [9]
    End point description
    Total IgA in saliva was assessed using enzyme-linked immunosorbent assay (ELISA).
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 10, 14, 21, and 180 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
    Adult - ID 9μg Adult - IM 15μg Elderly - ID 15μg Elderly - IM 15μg
    Number of subjects analysed
    38
    42
    40
    40
    Units: Titer (ng/ml)
    geometric mean (confidence interval 95%)
        D0
    130608 (93649 to 182154)
    81778 (50699 to 131907)
    115442 (76865 to 173380)
    99384 (63881 to 154619)
        D10
    124903 (79607 to 195973)
    114031 (69895 to 186036)
    97388 (66194 to 143282)
    70962 (34575 to 145642)
        D14
    113865 (75974 to 170652)
    99307 (54808 to 179933)
    100716 (68675 to 147706)
    76240 (48323 to 120286)
        D21
    125350 (85475 to 183828)
    68756 (31519 to 149984)
    103559 (66312 to 161727)
    75544 (45150 to 126398)
        D180
    111895 (55914 to 223926)
    74631 (32184 to 173062)
    67597 (29170 to 156645)
    39339 (14098 to 109768)
    No statistical analyses for this end point

    Primary: Geometric Mean Titers Ratios of Total IgA in Saliva in Adults and Elderly Subjects Vaccinated with an Inactivated Influenza Vaccine Administered By Intradermal or Intramuscular Route

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    End point title
    Geometric Mean Titers Ratios of Total IgA in Saliva in Adults and Elderly Subjects Vaccinated with an Inactivated Influenza Vaccine Administered By Intradermal or Intramuscular Route [10]
    End point description
    Total IgA in saliva was assessed using enzyme-linked immunosorbent assay (ELISA).
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 10, 14, 21, and 180 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
    Adult - ID 9μg Adult - IM 15μg Elderly - ID 15μg Elderly - IM 15μg
    Number of subjects analysed
    38
    42
    40
    40
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        D10/D0
    0.962 (0.707 to 1.31)
    1.39 (1.02 to 1.92)
    0.909 (0.699 to 1.18)
    0.701 (0.364 to 1.35)
        D14/D0
    0.872 (0.671 to 1.13)
    1.18 (0.659 to 2.1)
    1.04 (0.823 to 1.32)
    0.816 (0.603 to 1.1)
        D21/D0
    0.95 (0.736 to 1.23)
    0.887 (0.418 to 1.88)
    0.941 (0.639 to 1.39)
    0.76 (0.506 to 1.14)
        D180/D0
    1.08 (0.521 to 2.22)
    1.06 (0.486 to 2.32)
    0.614 (0.246 to 1.53)
    0.39 (0.134 to 1.13)
    No statistical analyses for this end point

    Primary: Geometric Mean Titers of Influenza-specific IgA in Saliva of Adults and Elderly Subjects Vaccinated with an Inactivated Influenza Vaccine Administered By Intradermal or Intramuscular Route

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    End point title
    Geometric Mean Titers of Influenza-specific IgA in Saliva of Adults and Elderly Subjects Vaccinated with an Inactivated Influenza Vaccine Administered By Intradermal or Intramuscular Route [11]
    End point description
    Influenza-specific IgA in saliva was assessed using enzyme-linked immunosorbent assay (ELISA).
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 10, 14, 21, and 180 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
    Adult - ID 9μg Adult - IM 15μg Elderly - ID 15μg Elderly - IM 15μg
    Number of subjects analysed
    38
    42
    40
    40
    Units: Titer (AU)
    geometric mean (confidence interval 95%)
        D0
    0.058 (0.027 to 0.124)
    0.014 (0.006 to 0.035)
    0.011 (0.004 to 0.027)
    0.014 (0.005 to 0.039)
        D10
    0.064 (0.029 to 0.141)
    0.041 (0.018 to 0.094)
    0.041 (0.015 to 0.108)
    0.029 (0.01 to 0.079)
        D14
    0.078 (0.037 to 0.163)
    0.025 (0.01 to 0.064)
    0.039 (0.015 to 0.106)
    0.046 (0.02 to 0.104)
        D21
    0.044 (0.021 to 0.095)
    0.058 (0.029 to 0.115)
    0.048 (0.023 to 0.101)
    0.015 (0.006 to 0.039)
        D180
    0.02 (0.007 to 0.057)
    0.021 (0.009 to 0.05)
    0.025 (0.008 to 0.075)
    0.017 (0.006 to 0.051)
    No statistical analyses for this end point

    Primary: Geometric Mean Titers Ratios of Influenza-specific IgA in Saliva of Adults and Elderly Subjects Vaccinated with an Inactivated Influenza Vaccine Administered By Intradermal or Intramuscular Route

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    End point title
    Geometric Mean Titers Ratios of Influenza-specific IgA in Saliva of Adults and Elderly Subjects Vaccinated with an Inactivated Influenza Vaccine Administered By Intradermal or Intramuscular Route [12]
    End point description
    Influenza-specifc IgA in saliva was assessed using enzyme-linked immunosorbent assay (ELISA).
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 10, 14, 21, and 180 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
    Adult - ID 9μg Adult - IM 15μg Elderly - ID 15μg Elderly - IM 15μg
    Number of subjects analysed
    38
    42
    40
    40
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        D10/D0
    1.19 (0.544 to 2.62)
    2.87 (1.33 to 6.16)
    4.83 (1.56 to 15)
    2.38 (0.789 to 7.15)
        D14/D0
    1.35 (0.602 to 3.02)
    1.33 (0.615 to 2.89)
    4.12 (1.38 to 12.3)
    3.3 (1.27 to 8.62)
        D21/D0
    0.664 (0.245 to 1.8)
    4.12 (1.7 to 9.96)
    4.54 (1.91 to 10.8)
    1.11 (0.424 to 2.91)
        D180/D0
    0.361 (0.115 to 1.13)
    1.56 (0.402 to 6.04)
    2.31 (0.662 to 8.06)
    1.13 (0.285 to 4.53)
    No statistical analyses for this end point

    Primary: Percentage of Subjects With At Least One Solicited Reaction Listed in the CPMP NfG Within 3 Days After Vaccination with Inactivated, Split-Virion Influenza Vaccine Administered by Either Intradermal or by Intramuscular Route

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    End point title
    Percentage of Subjects With At Least One Solicited Reaction Listed in the CPMP NfG Within 3 Days After Vaccination with Inactivated, Split-Virion Influenza Vaccine Administered by Either Intradermal or by Intramuscular Route [13]
    End point description
    Solicited injection site reactions: Injection site induration >5 cm for >3 days and Injection site ecchymosis. Solicited systemic reactions: Pyrexia (rectal temperature > 38°C) for ≥24 hours, Malaise, and Shivering.
    End point type
    Primary
    End point timeframe
    Day 0 up to Day 3 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
    Adult - ID 9μg Adult - IM 15μg Elderly - ID 15μg Elderly - IM 15μg
    Number of subjects analysed
    38
    42
    40
    40
    Units: Percentage of subjects
    number (not applicable)
        At least 1 reaction listed in CPMP recommendations
    37.8
    26.2
    12.5
    17.5
        Injection site induration >5 cm for >3 days
    0
    0
    0
    0
        Injection site ecchymosis
    10.8
    9.5
    2.5
    7.5
        Pyrexia (rectal temperature > 38°C) for ≥24 hours
    2.7
    7.1
    2.5
    0
        Malaise
    18.9
    7.1
    5
    5
        Shivering
    18.9
    11.9
    5
    7.5
    No statistical analyses for this end point

    Primary: Geometric Mean Ratios of Cytokine Secreting CD4 T Cells Post/Pre-Vaccination Ratio in Adults and Elderly Subjects Vaccinated with an Inactivated Influenza Vaccine Administered By Either Intradermal or Intramuscular Route

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    End point title
    Geometric Mean Ratios of Cytokine Secreting CD4 T Cells Post/Pre-Vaccination Ratio in Adults and Elderly Subjects Vaccinated with an Inactivated Influenza Vaccine Administered By Either Intradermal or Intramuscular Route [14]
    End point description
    Cellular immune response was assessed using the intracellular cytokine staining (ICS) method.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 7, 10, 14, 21, and 180 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
    Adult - ID 9μg Adult - IM 15μg Elderly - ID 15μg Elderly - IM 15μg
    Number of subjects analysed
    38
    42
    40
    40
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        IFN-γ+; A/H1N1 Solomon Island (D7/D0)
    1.03 (0.878 to 1.22)
    1.26 (0.92 to 1.72)
    1.23 (0.874 to 1.74)
    1.99 (1.34 to 2.94)
        IFN-γ+; A/H3N2 Wisconsin (D7/D0)
    0.867 (0.733 to 1.03)
    0.852 (0.676 to 1.07)
    0.908 (0.732 to 1.13)
    1.21 (0.903 to 1.62)
        IFN-γ+; B/Malaysia (D7/D0)
    1.02 (0.799 to 1.3)
    1.16 (0.912 to 1.48)
    1.08 (0.805 to 1.44)
    1.66 (1.08 to 2.57)
        IFN-γ+; A/H1N1 Solomon Island (D10/D0)
    1.23 (0.953 to 1.6)
    1.05 (0.777 to 1.42)
    1.24 (0.937 to 1.63)
    1.22 (0.849 to 1.76)
        IFN-γ+; A/H3N2 Wisconsin (D10/D0)
    1.01 (0.812 to 1.26)
    1 (0.859 to 1.17)
    1.02 (0.8 to 1.31)
    1.26 (0.985 to 1.62)
        IFN-γ+; B/Malaysia (D10/D0)
    1.15 (0.935 to 1.42)
    1.29 (1.08 to 1.54)
    1.11 (0.869 to 1.41)
    1.43 (1.1 to 1.87)
        IFN-γ+; A/H1N1 Solomon Island (D14/D0)
    1.08 (0.852 to 1.38)
    1.25 (0.974 to 1.61)
    1.19 (0.869 to 1.62)
    1.25 (0.98 to 1.6)
        IFN-γ+; A/H3N2 Wisconsin (D14/D0)
    0.95 (0.828 to 1.09)
    0.937 (0.767 to 1.14)
    0.976 (0.762 to 1.25)
    1.18 (0.904 to 1.54)
        IFN-γ+; B/Malaysia (D14/D0)
    1.13 (0.891 to 1.44)
    1.12 (0.902 to 1.38)
    1.02 (0.801 to 1.31)
    1.08 (0.763 to 1.52)
        IFN-γ+; A/H1N1 Solomon Island (D21/D0)
    1.08 (0.833 to 1.4)
    1.12 (0.857 to 1.47)
    1.26 (0.83 to 1.92)
    1.34 (0.91 to 1.98)
        IFN-γ+; A/H3N2 Wisconsin (D21/D0)
    0.903 (0.755 to 1.08)
    0.869 (0.679 to 1.11)
    1.11 (0.886 to 1.39)
    1.36 (1.08 to 1.72)
        IFN-γ+; B/Malaysia (D21/D0)
    1.06 (0.871 to 1.29)
    1.11 (0.885 to 1.39)
    1.27 (1 to 1.62)
    1.27 (0.983 to 1.64)
        IFN-γ+; A/H1N1 Solomon Island (D180/D0)
    1.5 (1.02 to 2.22)
    1.46 (0.972 to 2.2)
    1.07 (0.725 to 1.58)
    2 (1.45 to 2.75)
        IFN-γ+; A/H3N2 Wisconsin (D180/D0)
    1.59 (1.23 to 2.07)
    1.39 (1.08 to 2.79)
    1.55 (1.05 to 2.27)
    1.76 (1.22 to 2.55)
        IFN-γ+; B/Malaysia (D180/D0)
    1.27 (0.894 to 1.81)
    1.25 (0.944 to 1.66)
    1.36 (1.08 to 1.71)
    1.54 (1.05 to 2.27)
        TNF-α+; A/H1N1 Solomon Island (D7/D0)
    0.722 (0.57 to 0.915)
    0.889 (0.689 to 1.15)
    0.879 (0.662 to 1.17)
    1.92 (1.37 to 2.7)
        TNF-α+; A/H3N2 Wisconsin (D7/D0)
    0.907 (0.738 to 1.12)
    0.948 (0.739 to 1.22)
    0.929 (0.677 to 1.28)
    1.27 (0.927 to 1.73)
        TNF-α+; B/Malaysia (D7/D0)
    0.996 (0.828 to 1.2)
    0.991 (0.837 to 1.17)
    1.01 (0.79 to 1.3)
    1.42 (0.895 to 2.25)
        TNF-α+; A/H1N1 Solomon Island (D10/D0)
    0.945 (0.743 to 1.14)
    0.912 (0.777 to 1.07)
    0.957 (0.738 to 1.24)
    1.41 (1.05 to 1.9)
        TNF-α+; A/H3N2 Wisconsin (D10/D0)
    0.945 (0.735 to 1.22)
    1.23 (0.962 to 1.56)
    1.2 (0.88 to 1.64)
    0.971 (0.717 to 1.31)
        TNF-α+; B/Malaysia (D10/D0)
    1.11 (0.918 to 1.35)
    1 (0.869 to 1.16)
    1.05 (0.879 to 1.25)
    1.26 (1.03 to 1.53)
        TNF-α+; A/H1N1 Solomon Island (D14/D0)
    0.844 (0.66 to 1.08)
    0.988 (0.843 to 1.16)
    1.07 (0.839 to 1.37)
    1.33 (0.999 to 1.78)
        TNF-α+; A/H3N2 Wisconsin (D14/D0)
    0.963 (0.738 to 1.26)
    0.918 (0.64 to 1.32)
    1.2 (0.895 to 1.61)
    1.48 (1.06 to 2.06)
        TNF-α+; B/Malaysia (D14/D0)
    1.08 (0.891 to 1.3)
    1.06 (0.902 to 1.24)
    1.26 (0.963 to 1.64)
    1.1 (0.811 to 1.5)
        TNF-α+; A/H1N1 Solomon Island (D21/D0)
    0.859 (0.694 to 1.06)
    0.961 (0.798 to 1.16)
    1.04 (0.774 to 1.39)
    1.05 (0.72 to 1.52)
        TNF-α+; A/H3N2 Wisconsin (D21/D0)
    1.08 (0.758 to 1.54)
    1.03 (0.736 to 1.45)
    1.43 (1.06 to 1.94)
    1.45 (1.06 to 1.98)
        TNF-α+; B/Malaysia (D21/D0)
    1.03 (0.848 to 1.24)
    1.07 (0.91 to 1.25)
    1.25 (1.05 to 1.48)
    1.21 (0.888 to 1.66)
        TNF-α+; A/H1N1 Solomon Island (D180/D0)
    0.469 (0.344 to 0.64)
    0.689 (0.519 to 0.913)
    0.834 (0.524 to 1.33)
    1.43 (1.06 to 1.94)
        TNF-α+; A/H3N2 Wisconsin (D180/D0)
    0.811 (0.539 to 1.22)
    0.92 (0.617 to 1.37)
    0.963 (0.545 to 1.7)
    1.45 (1.01 to 2.08)
        TNF-α+; B/Malaysia (D180/D0)
    0.921 (0.649 to 1.31)
    1.01 (0.8 to 1.27)
    1.15 (0.829 to 1.61)
    1.89 (1.26 to 2.85)
        IL-2+; A/H1N1 Solomon Island (D7/D0)
    0.701 (0.557 to 0.883)
    0.847 (0.629 to 1.14)
    0.976 (0.701 to 1.36)
    1.53 (1.19 to 1.96)
        IL-2+; A/H3N2 Wisconsin (D7/D0)
    0.873 (0.66 to 1.15)
    0.985 (0.727 to 1.33)
    1.11 (0.834 to 1.49)
    1.41 (1.08 to 1.86)
        IL-2+; B/Malaysia (D7/D0)
    0.955 (0.808 to 1.13)
    1.02 (0.738 to 1.4)
    0.931 (0.693 to 1.25)
    1.26 (0.917 to 1.72)
        IL-2+; A/H1N1 Solomon Island (D10/D0)
    1.03 (0.794 to 1.33)
    1 (0.789 to 1.27)
    1.24 (0.876 to 1.74)
    1.55 (1.16 to 2.07)
        IL-2+; A/H3N2 Wisconsin (D10/D0)
    0.696 (0.472 to 1.03)
    0.965 (0.742 to 1.25)
    1.22 (0.836 to 1.78)
    1.47 (1.09 to 1.98)
        IL-2+; B/Malaysia (D10/D0)
    1.18 (0.943 to 1.47)
    1.2 (0.823 to 1.74)
    1.38 (1.04 to 1.84)
    1.47 (1.08 to 2)
        IL-2+; A/H1N1 Solomon Island (D14/D0)
    1.06 (0.813 to 1.39)
    1.11 (0.886 to 1.4)
    1.34 (0.987 to 1.82)
    1.75 (1.28 to 2.4)
        IL-2+; A/H3N2 Wisconsin (D14/D0)
    0.738 (0.491 to 1.11)
    1.13 (0.821 to 1.54)
    1.18 (0.774 to 1.81)
    1.68 (1.15 to 2.46)
        IL-2+; B/Malaysia (D14/D0)
    1.3 (0.959 to 1.75)
    1.42 (1.08 to 1.88)
    1.55 (1.11 to 2.16)
    1.73 (1.21 to 2.47)
        IL-2+; A/H1N1 Solomon Island (D21/D0)
    1.07 (0.854 to 1.33)
    1.11 (0.88 to 1.4)
    1.18 (0.793 to 1.76)
    1.76 (1.18 to 2.63)
        IL-2+; A/H3N2 Wisconsin (D21/D0)
    0.875 (0.627 to 1.22)
    1.05 (0.746 to 1.48)
    1.2 (0.817 to 1.77)
    1.94 (1.3 to 2.9)
        IL-2+; B/Malaysia (D21/D0)
    1.29 (1.03 to 1.6)
    1.59 (1.12 to 2.27)
    1.39 (0.991 to 1.95)
    1.82 (1.41 to 2.37)
        IL-2+; A/H1N1 Solomon Island (D180/D0)
    0.899 (0.621 to 1.27)
    1.25 (0.956 to 1.64)
    1.28 (0.838 to 1.95)
    2.02 (1.56 to 2.6)
        IL-2+; A/H3N2 Wisconsin (D180/D0)
    0.853 (0.584 to 1.24)
    1.1 (0.797 to 1.52)
    1.04 (0.633 to 1.71)
    1.76 (1.25 to 2.49)
        IL-2+; B/Malaysia (D180/D0)
    1.21 (0.82 to 1.79)
    1.67 (1.2 to 2.33)
    1.43 (1.05 to 1.94)
    2.37 (1.65 to 3.41)
        TNF-α+/IFN-γ+; A/H1N1 Solomon Island (D7/D0)
    1.14 (0.913 to 1.42)
    1.28 (0.891 to 1.85)
    1.33 (0.948 to 1.85)
    2.63 (1.71 to 4.04)
        TNF-α+/IFN-γ+; A/H3N2 Wisconsin (D7/D0)
    0.987 (0.739 to 1.32)
    1.09 (0.789 to 1.51)
    1.2 (0.853 to 1.68)
    1.56 (1.02 to 2.4)
        TNF-α+/IFN-γ+; B/Malaysia (D7/D0)
    1.16 (0.93 to 1.44)
    1.34 (1.04 to 1.73)
    1.18 (0.793 to 1.75)
    2.44 (1.36 to 4.36)
        TNF-α+/IFN-γ+; A/H1N1 Solomon Island (D10/D0)
    0.98 (0.77 to 1.25)
    1.08 (0.816 to 1.43)
    0.912 (0.671 to 1.24)
    1.42 (1.1 to 1.83)
        TNF-α+/IFN-γ+; A/H3N2 Wisconsin (D10/D0)
    1.07 (0.779 to 1.46)
    1.48 (1.08 to 2.02)
    1.43 (1.02 to 1.99)
    1.31 (0.949 to 1.81)
        TNF-α+/IFN-γ+; B/Malaysia (D10/D0)
    1.08 (0.9 to 1.3)
    1.13 (0.895 to 1.42)
    1.21 (0.912 to 1.6)
    1.87 (1.31 to 2.67)
        TNF-α+/IFN-γ+; A/H1N1 Solomon Island (D14/D0)
    0.77 (0.565 to 1.05)
    1.17 (0.878 to 1.56)
    1.16 (0.929 to 1.46)
    1.66 (1.25 to 2.21)
        TNF-α+/IFN-γ+; A/H3N2 Wisconsin (D14/D0)
    0.913 (0.69 to 1.21)
    1.13 (0.853 to 1.5)
    1.13 (0.753 to 1.68)
    1.55 (1.11 to 2.18)
        TNF-α+/IFN-γ+; B/Malaysia (D14/D0)
    1.03 (0.825 to 1.3)
    1.18 (1.01 to 1.37)
    1.25 (0.846 to 1.84)
    1.47 (0.983 to 2.19)
        TNF-α+/IFN-γ+; A/H1N1 Solomon Island (D21/D0)
    0.914 (0.767 to 1.09)
    1.1 (0.824 to 1.46)
    1.06 (0.752 to 1.49)
    1.46 (1.06 to 2)
        TNF-α+/IFN-γ+; A/H3N2 Wisconsin (D21/D0)
    1.09 (0.806 to 1.47)
    1.06 (0.748 to 1.5)
    1.45 (1.03 to 2.04)
    1.72 (1.24 to 2.37)
        TNF-α+/IFN-γ+; B/Malaysia (D21/D0)
    0.984 (0.789 to 1.23)
    1.23 (0.968 to 1.56)
    1.32 (0.922 to 1.89)
    1.74 (1.3 to 2.34)
        TNF-α+/IFN-γ+; A/H1N1 Solomon Island (D180/D0)
    1.12 (0.838 to 1.49)
    1.61 (1.16 to 2.22)
    1.6 (1.18 to 2.19)
    2.13 (1.67 to 2.72)
        TNF-α+/IFN-γ+; A/H3N2 Wisconsin (D180/D0)
    1.58 (1.04 to 2.41)
    1.66 (1.14 to 2.42)
    1.69 (1.08 to 2.66)
    2.22 (1.64 to 3.02)
        TNF-α+/IFN-γ+; B/Malaysia (D180/D0)
    1.31 (0.971 to 1.76)
    1.45 (1.09 to 1.92)
    1.43 (1.06 to 1.94)
    2.14 (1.42 to 3.21)
        IFN-γ+/IL-2+; A/H1N1 Solomon Island (D7/D0)
    0.815 (0.644 to 1.03)
    0.931 (0.704 to 1.23)
    1.06 (0.782 to 1.44)
    1.66 (1.3 to 2.13)
        IFN-γ+/IL-2+; A/H3N2 Wisconsin (D7/D0)
    0.804 (0.624 to 1.04)
    1.09 (0.791 to 1.49)
    1.1 (0.845 to 1.42)
    0.997 (0.785 to 1.27)
        IFN-γ+/IL-2+; B/Malaysia (D7/D0)
    0.783 (0.55 to 1.11)
    1.15 (0.869 to 1.52)
    0.795 (0.593 to 1.08)
    1.1 (0.876 to 1.38)
        IFN-γ+/IL-2+; A/H1N1 Solomon Island (D10/D0)
    1.16 (0.888 to 1.51)
    1.08 (0.847 to 1.38)
    0.963 (0.706 to 1.31)
    1.37 (1.12 to 1.66)
        IFN-γ+/IL-2+; A/H3N2 Wisconsin (D10/D0)
    0.91 (0.66 to 1.25)
    1.1 (0.872 to 1.39)
    0.998 (0.75 to 1.33)
    1.11 (0.866 to 1.43)
        IFN-γ+/IL-2+; B/Malaysia (D10/D0)
    1.15 (0.863 to 1.54)
    1.06 (0.768 to 1.46)
    1.26 (0.909 to 1.76)
    1.11 (0.829 to 1.5)
        IFN-γ+/IL-2+; A/H1N1 Solomon Island (D14/D0)
    1.05 (0.771 to 1.42)
    1.17 (0.859 to 1.59)
    1.25 (0.955 to 1.62)
    1.62 (1.22 to 2.15)
        IFN-γ+/IL-2+; A/H3N2 Wisconsin (D14/D0)
    0.831 (0.58 to 1.19)
    1.01 (0.741 to 1.39)
    1.24 (0.911 to 1.68)
    1.56 (1.2 to 2.03)
        IFN-γ+/IL-2+; B/Malaysia (D14/D0)
    1.09 (0.763 to 1.55)
    1.35 (1.02 to 1.79)
    1.19 (0.888 to 1.61)
    1.32 (0.988 to 1.75)
        IFN-γ+/IL-2+; A/H1N1 Solomon Island (D21/D0)
    1.05 (0.804 to 1.38)
    1.04 (0.773 to 1.41)
    1.3 (0.907 to 1.87)
    1.69 (1.23 to 2.31)
        IFN-γ+/IL-2+; A/H3N2 Wisconsin (D21/D0)
    0.969 (0.667 to 1.41)
    1.02 (0.721 to 1.46)
    1.17 (0.837 to 1.62)
    1.53 (1.14 to 2.04)
        IFN-γ+/IL-2+; B/Malaysia (D21/D0)
    1.11 (0.822 to 1.5)
    1.5 (1.13 to 1.99)
    1.43 (1.03 to 1.99)
    1.51 (1.16 to 1.95)
        IFN-γ+/IL-2+; A/H1N1 Solomon Island (D180/D0)
    1.23 (0.899 to 1.68)
    1.44 (1.05 to 1.96)
    1.52 (1.11 to 2.1)
    1.96 (1.58 to 2.42)
        IFN-γ+/IL-2+; A/H3N2 Wisconsin (D180/D0)
    1.09 (0.725 to 1.64)
    1.27 (0.996 to 1.63)
    0.843 (0.599 to 1.19)
    1.51 (1.08 to 1.85)
        IFN-γ+/IL-2+; B/Malaysia (D180/D0)
    1.25 (0.882 to 1.77)
    1.56 (1.1 to 2.21)
    1.08 (0.793 to 1.47)
    1.41 (1.19 to 1.91)
        TNF-α+/IL-2+; A/H1N1 Solomon Island (D7/D0)
    0.566 (0.421 to 0.761)
    0.703 (0.526 to 0.941)
    0.69 (0.521 to 0.913)
    1.1 (0.822 to 1.47)
        TNF-α+/IL-2+; A/H3N2 Wisconsin (D7/D0)
    0.719 (0.538 to 0.959)
    0.999 (0.766 to 1.3)
    0.934 (0.725 to 1.2)
    0.856 (0.672 to 1.09)
        TNF-α+/IL-2+; B/Malaysia (D7/D0)
    0.785 (0.589 to 1.05)
    0.894 (0.689 to 1.16)
    0.729 (0.542 to 0.98)
    0.96 (0.743 to 1.24)
        TNF-α+/IL-2+; A/H1N1 Solomon Island (D10/D0)
    0.894 (0.635 to 1.26)
    0.848 (0.648 to 1.11)
    1.08 (0.829 to 1.4)
    1.17 (0.912 to 1.51)
        TNF-α+/IL-2+; A/H3N2 Wisconsin (D10/D0)
    0.787 (0.551 to 1.13)
    1.04 (0.803 to 1.34)
    1.17 (0.851 to 1.62)
    1.08 (0.798 to 1.46)
        TNF-α+/IL-2+; B/Malaysia (D10/D0)
    1.09 (0.792 to 1.5)
    1 (0.703 to 1.42)
    1.27 (0.999 to 1.62)
    1.2 (0.881 to 1.65)
        TNF-α+/IL-2+; A/H1N1 Solomon Island (D14/D0)
    0.95 (0.696 to 1.3)
    0.935 (0.696 to 1.26)
    1.19 (0.865 to 1.64)
    1.53 (1.2 to 1.94)
        TNF-α+/IL-2+; A/H3N2 Wisconsin (D14/D0)
    0.818 (0.597 to 1.12)
    1.01 (0.75 to 1.36)
    1.19 (0.853 to 1.65)
    1.24 (0.896 to 1.72)
        TNF-α+/IL-2+; B/Malaysia (D14/D0)
    1.13 (0.784 to 1.63)
    1.48 (1.16 to 1.88)
    1.46 (1.08 to 1.98)
    1.44 (0.984 to 2.12)
        TNF-α+/IL-2+; A/H1N1 Solomon Island (D21/D0)
    0.909 (0.68 to 1.21)
    1.01 (0.749 to 1.35)
    1.09 (0.763 to 1.55)
    1.53 (1.08 to 2.16)
        TNF-α+/IL-2+; A/H3N2 Wisconsin (D21/D0)
    0.956 (0.712 to 1.28)
    0.929 (0.657 to 1.31)
    1.1 (0.808 to 1.5)
    1.44 (1.03 to 2.02)
        TNF-α+/IL-2+; B/Malaysia (D21/D0)
    1.13 (0.813 to 1.57)
    1.5 (1.08 to 2.08)
    1.53 (1.23 to 1.89)
    1.74 (1.39 to 2.17)
        TNF-α+/IL-2+; A/H1N1 Solomon Island (D180/D0)
    0.888 (0.614 to 1.28)
    1.28 (0.923 to 1.77)
    1.43 (0.971 to 2.1)
    1.96 (1.48 to 2.59)
        TNF-α+/IL-2+; A/H3N2 Wisconsin (D180/D0)
    0.977 (0.711 to 1.34)
    1.12 (0.819 to 1.52)
    0.959 (0.639 to 1.44)
    1.2 (0.861 to 1.66)
        TNF-α+/IL-2+; B/Malaysia (D180/D0)
    1.28 (0.971 to 1.9)
    1.61 (1.14 to 2.26)
    1.47 (1.12 to 1.93)
    2.55 (1.78 to 3.67)
        IFN-γ+/TNF-α+/IL-2+; A/H1N1 Solomon Island (D7/D0)
    0.737 (0.568 to 0.956)
    0.826 (0.631 to 1.08)
    0.949 (0.692 to 1.3)
    1.23 (0.974 to 1.54)
        IFN-γ+/TNF-α+/IL-2+; A/H3N2 Wisconsin (D7/D0)
    0.87 (0.677 to 1.12)
    1.2 (0.911 to 1.59)
    0.977 (0.785 to 1.22)
    0.875 (0.71 to 1.08)
        IFN-γ+/TNF-α+/IL-2+; B/Malaysia (D7/D0)
    0.79 (0.586 to 1.06)
    0.993 (0.749 to 1.32)
    0.709 (0.544 to 0.925)
    0.828 (0.648 to 1.06)
        IFN-γ+/TNF-α+/IL-2+;A/H1N1 Solomon Island (D10/D0)
    0.931 (0.706 to 1.23)
    0.977 (0.724 to 1.32)
    0.982 (0.725 to 1.33)
    1.06 (0.903 to 1.25)
        IFN-γ+/TNF-α+/IL-2+; A/H3N2 Wisconsin (D10/D0)
    0.917 (0.66 to 1.27)
    1.21 (0.925 to 1.6)
    1.16 (0.873 to 1.53)
    1.11 (0.909 to 1.35)
        IFN-γ+/TNF-α+/IL-2+; B/Malaysia (D10/D0)
    1.08 (0.805 to 1.45)
    1.04 (0.77 to 1.41)
    1.07 (0.876 to 1.31)
    1.17 (0.899 to 1.53)
        IFN-γ+/TNF-α+/IL-2+;A/H1N1 Solomon Island (D14/D0)
    0.849 (0.663 to 1.09)
    1.04 (0.766 to 1.41)
    1.15 (0.883 to 1.51)
    1.51 (1.15 to 2)
        IFN-γ+/TNF-α+/IL-2+; A/H3N2 Wisconsin (D14/D0)
    0.818 (0.604 to 1.11)
    0.992 (0.747 to 1.32)
    1.09 (0.842 to 1.41)
    1.14 (0.897 to 1.45)
        IFN-γ+/TNF-α+/IL-2+; B/Malaysia (D14/D0)
    1.11 (0.805 to 1.53)
    1.53 (1.19 to 1.98)
    1.26 (0.989 to 1.61)
    1.28 (0.951 to 1.72)
        IFN-γ+/TNF-α+/IL-2+;A/H1N1 Solomon Island (D21/D0)
    0.824 (0.626 to 1.08)
    0.932 (0.706 to 1.23)
    1.21 (0.91 to 1.61)
    1.46 (1.07 to 1.99)
        IFN-γ+/TNF-α+/IL-2+; A/H3N2 Wisconsin (D21/D0)
    1.02 (0.745 to 1.39)
    0.983 (0.703 to 1.38)
    1.13 (0.919 to 1.4)
    1.42 (1.11 to 1.82)
        IFN-γ+/TNF-α+/IL-2+; B/Malaysia (D21/D0)
    1.17 (0.881 to 1.55)
    1.45 (1.07 to 1.96)
    1.25 (0.955 to 1.63)
    1.78 (1.38 to 2.29)
        IFN-γ+/TNF-α+/IL-2+;A/H1N1 Solomon Island; D180/D0
    1.26 (0.908 to 1.74)
    1.61 (1.2 to 2.16)
    1.86 (1.39 to 2.49)
    2.04 (1.67 to 2.49)
        IFN-γ+/TNF-α+/IL-2+; A/H3N2 Wisconsin (D180/D0)
    1.34 (0.931 to 1.92)
    1.29 (0.952 to 1.76)
    0.991 (0.764 to 1.29)
    1.2 (0.921 to 1.56)
        IFN-γ+/TNF-α+/IL-2+; B/Malaysia (D180/D0)
    1.41 (0.94 to 2.12)
    1.63 (1.2 to 2.21)
    1.1 (0.839 to 1.44)
    1.59 (1.19 to 2.12)
    No statistical analyses for this end point

    Secondary: Percentage of Subjects With At Least One Solicited Injection-site and Systemic Reactions Within 7 Days After Vaccination with Inactivated, Split-Virion Influenza Vaccine Administered by Either Intradermal or by Intramuscular Route

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    End point title
    Percentage of Subjects With At Least One Solicited Injection-site and Systemic Reactions Within 7 Days After Vaccination with Inactivated, Split-Virion Influenza Vaccine Administered by Either Intradermal or by Intramuscular Route
    End point description
    Solicited injection site: Pain, Pruritus, Erythema, Swelling, Induration and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3 injection site: Pain and Pruritus – Incapacitating, unable to perform usual activities; Erythema, Swelling, Induration, and Ecchymosis – ≥5 cm. Grade 3 systemic reactions: Fever – ≥39.0°C; Headache, Malaise, Myalgia, and Shivering – Prevents daily activities.
    End point type
    Secondary
    End point timeframe
    Day 0 up to Day 7 post-vaccination
    End point values
    Adult - ID 9μg Adult - IM 15μg Elderly - ID 15μg Elderly - IM 15μg
    Number of subjects analysed
    38
    42
    40
    40
    Units: Percentage of subjects
    number (not applicable)
        Injection site Pain
    59.5
    73.8
    32.5
    27.5
        Grade 3 Injection site Pain
    0
    0
    0
    0
        Injection site Pruritus
    56.8
    26.2
    55
    25
        Grade 3 Injection site Pruritus
    0
    0
    0
    0
        Injection site Erythema
    91.9
    54.8
    85
    52.5
        Grade 3 Injection site Erythema
    59.5
    16.7
    25
    20
        Injection site Swelling
    70.3
    28.6
    65
    27.5
        Grade 3 Injection site Swelling
    10.8
    9.5
    5
    0
        Injection site Induration
    91.9
    52.4
    90
    47.5
        Grade 3 Injection site Induration
    13.5
    14.3
    0
    0
        Injection site Ecchymosis
    21.6
    9.5
    5
    7.5
        Grade 3 Injection site Ecchymosis
    0
    0
    0
    0
        Fever
    10.8
    11.9
    5
    0
        Grade 3 Fever
    0
    2.4
    0
    0
        Headache
    51.4
    50
    20
    25
        Grade 3 Headache
    2.7
    2.4
    0
    0
        Malaise
    21.6
    11.9
    5
    7.5
        Grade 3 Malaise
    2.7
    4.8
    0
    0
        Myalgia
    40.5
    33.3
    22.5
    22.5
        Grade 3 Myalgia
    2.7
    4.8
    0
    0
        Shivering
    21.6
    14.3
    7.5
    12.5
        Grade 3 Shivering
    2.7
    4.8
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse event data were collected form Day 0 (post-vaccination) up to Day 180 post-vaccination.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    Adult - ID 9μg
    Reporting group description
    Adults 18-40 years of age who received the ID influenza vaccine (split-virion, inactivated), 2007-2008 Northern Hemisphere (NH) formulation (9 μg).

    Reporting group title
    Adult - IM 15μg
    Reporting group description
    Adults 18-40 years of age who received the IM influenza vaccine (split-virion, inactivated), 2007-2008 NH formulation (Vaxigrip®; 15 μg).

    Reporting group title
    Elderly - ID 15μg
    Reporting group description
    Elderly subjects 60-85 years of age who received the ID influenza vaccine (split-virion, inactivated), 2007-2008 Northern Hemisphere (NH) formulation (15 μg).

    Reporting group title
    Elderly - IM 15μg
    Reporting group description
    Elderly subjects 60-85 years of age who received the IM influenza vaccine (split-virion, inactivated), 2007-2008 NH formulation (Vaxigrip®; 15 μg).

    Serious adverse events
    Adult - ID 9μg Adult - IM 15μg Elderly - ID 15μg Elderly - IM 15μg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 42 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastasis
         subjects affected / exposed
    0 / 38 (0.00%)
    0 / 42 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 38 (2.63%)
    0 / 42 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Adult - ID 9μg Adult - IM 15μg Elderly - ID 15μg Elderly - IM 15μg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    34 / 38 (89.47%)
    31 / 42 (73.81%)
    36 / 40 (90.00%)
    21 / 40 (52.50%)
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed [1]
    2 / 37 (5.41%)
    0 / 42 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
         occurrences all number
    2
    0
    1
    0
    Nervous system disorders
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    19 / 37 (51.35%)
    21 / 42 (50.00%)
    8 / 40 (20.00%)
    10 / 40 (25.00%)
         occurrences all number
    19
    21
    8
    40
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed [3]
    2 / 37 (5.41%)
    1 / 42 (2.38%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
         occurrences all number
    2
    1
    1
    1
    Injection site pain
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    22 / 37 (59.46%)
    31 / 42 (73.81%)
    13 / 40 (32.50%)
    11 / 40 (27.50%)
         occurrences all number
    22
    31
    13
    11
    Injection site erythema
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    34 / 37 (91.89%)
    23 / 42 (54.76%)
    34 / 40 (85.00%)
    21 / 40 (52.50%)
         occurrences all number
    34
    23
    34
    21
    Injection site swelling
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    26 / 37 (70.27%)
    12 / 42 (28.57%)
    26 / 40 (65.00%)
    11 / 40 (27.50%)
         occurrences all number
    26
    12
    26
    11
    Injection site ecchymosis
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    8 / 37 (21.62%)
    4 / 42 (9.52%)
    2 / 40 (5.00%)
    3 / 40 (7.50%)
         occurrences all number
    8
    4
    2
    3
    Fever
    alternative assessment type: Systematic
         subjects affected / exposed [8]
    4 / 37 (10.81%)
    5 / 42 (11.90%)
    2 / 40 (5.00%)
    0 / 40 (0.00%)
         occurrences all number
    4
    5
    2
    0
    Malaise
    alternative assessment type: Systematic
         subjects affected / exposed [9]
    8 / 37 (21.62%)
    5 / 42 (11.90%)
    2 / 40 (5.00%)
    3 / 40 (7.50%)
         occurrences all number
    8
    5
    2
    3
    Shivering
    alternative assessment type: Systematic
         subjects affected / exposed [10]
    8 / 37 (21.62%)
    6 / 42 (14.29%)
    3 / 40 (7.50%)
    5 / 40 (12.50%)
         occurrences all number
    8
    6
    3
    5
    Skin and subcutaneous tissue disorders
    Injection site pruritus
    alternative assessment type: Systematic
         subjects affected / exposed [11]
    21 / 37 (56.76%)
    11 / 42 (26.19%)
    22 / 40 (55.00%)
    10 / 40 (25.00%)
         occurrences all number
    21
    11
    22
    10
    Injection site induration
    alternative assessment type: Systematic
         subjects affected / exposed [12]
    34 / 37 (91.89%)
    22 / 42 (52.38%)
    36 / 40 (90.00%)
    19 / 40 (47.50%)
         occurrences all number
    34
    22
    36
    19
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed [13]
    1 / 37 (2.70%)
    1 / 42 (2.38%)
    2 / 40 (5.00%)
    4 / 40 (10.00%)
         occurrences all number
    1
    1
    2
    4
    Myalgia
    alternative assessment type: Systematic
         subjects affected / exposed [14]
    15 / 37 (40.54%)
    14 / 42 (33.33%)
    9 / 40 (22.50%)
    9 / 40 (22.50%)
         occurrences all number
    15
    14
    9
    9
    Infections and infestations
    Rhinitis
         subjects affected / exposed [15]
    2 / 37 (5.41%)
    1 / 42 (2.38%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
         occurrences all number
    2
    1
    1
    1
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a unsolicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a unsolicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [13] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a unsolicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [14] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a solicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.
    [15] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: This was a unsolicited adverse event recorded in a diary card within 7 days of vaccination; the total number (N) reflects those subjects for which the diary cards were returned and for which data were available for the event during the period.

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Dec 2007
    Addressed observational objectives in order to further explore and document the influenza-specific B-cell response and B- and T-cell repertoires both qualitatively and quantitatively for each vaccine administered by the intradermal and intramuscular route

    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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