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    Clinical Trial Results:
    Immunogenicity of the Investigational Inactivated, Split-Virion Influenza Vaccine Administered by the Intradermal Route in Comparison with the Intramuscular Reference Vaccine Vaxigrip in the Elderly

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2006-002366-18
    Trial protocol
    		 BE   LT   IT  
    Global end of trial date
    16 Jun 2009

    Results information
    Results version number
    		 v2(current)
    This version publication date
    18 Feb 2016
    First version publication date
    27 Mar 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason
    • Correction of full data set
    CI of secondary outcome on GMTR for !D 15 ug group were shifted

    Trial information

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    Trial identification
    Sponsor protocol code
    GID17
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00383526
    WHO universal trial number (UTN)
    		 -
    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 55, stephanie.pepin@sanofipasteur.com
    Scientific contact
    Director, Clinical Development, Sanofi Pasteur SA, 33 4 37 37 58 55, 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
    18 Sep 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Jun 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that the intradermal (ID) investigational vaccine induces a better immunogenicity than the intramuscular (IM) reference vaccine in terms of seroprotection rate after the first 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
    		 Not applicable
    Actual start date of recruitment
    11 Sep 2006
    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
    Belgium: 775
    Country: Number of subjects enrolled
    France: 2397
    Country: Number of subjects enrolled
    Italy: 235
    Country: Number of subjects enrolled
    Lithuania: 300
    Worldwide total number of subjects
    3707
    EEA total number of subjects
    3707
    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)
    913
    From 65 to 84 years
    2740
    85 years and over
    54

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study subjects were enrolled from 11 September 2006 to 31 October 2006 at 37 clinical centers (24 in France, 2 in Italy, 8 in Belgium, and 3 in Lithuania) at Year 0 and 1 and 35 centers (24 in France, 2 in Italy, 6 in Belgium and 3 in Lithuania) at Year 2.

    Pre-assignment
    Screening details
    		 A total of 3707 subjects who met all of the inclusion criteria and none of the exclusion criteria were enrolled and randomized, 3659 subjects were 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
    		 ID 15μg
    Arm description
    		 Subjects who received 3 vaccinations of inactivated, split-virion (with octoxynol-9) investigational influenza vaccine via the intradermal (ID) route. For the first vaccination, subjects received the 2006-2007 Northern Hemisphere [NH] formulation on Day 0 (Year 0). For the second vaccination, subjects received the 2007-2008 NH formulation on Day 365 (Year 1). For the third vaccination, subjects received the 2008-2009 NH formulation on Day 730 (Year 2).
    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, ID into the upper arm (deltoid area) with the Becton Dickinson (BD) ID micro-injection system, 3 vaccinations of inactivated, split-virion (with octoxynol-9) investigational influenza vaccine with the 2006-2007 Northern Hemisphere [NH] formulation administered on Day 0 (Year 0), the 2007-2008 NH formulation on Day 365 (Year 1), and the 2008-2009 NH formulation on Day 730 (Year 2).

    Arm title
    		 IM 15μg
    Arm description
    		 Subjects who received 3 vaccinations of inactivated, split-virion (with octoxynol-9) influenza vaccine via the intramuscular (IM) route. For the first vaccination, subjects received the 2006-2007 Northern Hemisphere [NH] formulation on Day 0 (Year 0). For the second vaccination, subjects received the 2007-2008 NH formulation on Day 365 (Year 1). For the third vaccination, subjects received the 2008-2009 NH formulation on Day 730 (Year 2).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    VAXIGRIP
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe, Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use, Intramuscular use
    Dosage and administration details
    0.5 mL dose, IM into the upper arm (deltoid area), 3 vaccinations of inactivated, split-virion (with octoxynol-9) influenza vaccine with the 2006-2007 Northern Hemisphere [NH] formulation administered on Day 0 (Year 0), the 2007-2008 NH formulation administered on Day 365 (Year 1), and the 2008-2009 NH formulation on Day 730 (Year 2).

    Number of subjects in period 1
    		ID 15μg IM 15μg
    Started
    2618
    1089
    Completed
    2457
    1023
    Not completed
    161
    66
         Consent withdrawn by subject
    107
    49
         Adverse event, non-fatal
    3
    3
         Serious adverse event
    21
    6
         Lost to follow-up
    -
    1
         Protocol deviation
    30
    7

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    ID 15μg
    Reporting group description
    		 Subjects who received 3 vaccinations of inactivated, split-virion (with octoxynol-9) investigational influenza vaccine via the intradermal (ID) route. For the first vaccination, subjects received the 2006-2007 Northern Hemisphere [NH] formulation on Day 0 (Year 0). For the second vaccination, subjects received the 2007-2008 NH formulation on Day 365 (Year 1). For the third vaccination, subjects received the 2008-2009 NH formulation on Day 730 (Year 2).

    Reporting group title
    IM 15μg
    Reporting group description
    		 Subjects who received 3 vaccinations of inactivated, split-virion (with octoxynol-9) influenza vaccine via the intramuscular (IM) route. For the first vaccination, subjects received the 2006-2007 Northern Hemisphere [NH] formulation on Day 0 (Year 0). For the second vaccination, subjects received the 2007-2008 NH formulation on Day 365 (Year 1). For the third vaccination, subjects received the 2008-2009 NH formulation on Day 730 (Year 2).

    Reporting group values
    		 ID 15μg IM 15μg Total
    Number of subjects
    		 2618 1089 3707
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 658 255 913
        From 65-84 years
    		 1918 822 2740
        85 years and over
    		 42 12 54
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 70.7 ± 6.8 70.9 ± 6.7 -
    Gender categorical
    Units: Subjects
        Female
    		 1428 590 2018
        Male
    		 1190 499 1689

    End points

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    End points reporting groups
    Reporting group title
    ID 15μg
    Reporting group description
    		 Subjects who received 3 vaccinations of inactivated, split-virion (with octoxynol-9) investigational influenza vaccine via the intradermal (ID) route. For the first vaccination, subjects received the 2006-2007 Northern Hemisphere [NH] formulation on Day 0 (Year 0). For the second vaccination, subjects received the 2007-2008 NH formulation on Day 365 (Year 1). For the third vaccination, subjects received the 2008-2009 NH formulation on Day 730 (Year 2).

    Reporting group title
    IM 15μg
    Reporting group description
    		 Subjects who received 3 vaccinations of inactivated, split-virion (with octoxynol-9) influenza vaccine via the intramuscular (IM) route. For the first vaccination, subjects received the 2006-2007 Northern Hemisphere [NH] formulation on Day 0 (Year 0). For the second vaccination, subjects received the 2007-2008 NH formulation on Day 365 (Year 1). For the third vaccination, subjects received the 2008-2009 NH formulation on Day 730 (Year 2).

    Primary: Geometric Mean Titers of Influenza Antibodies Before and After Vaccination with Investigational Inactivated, Split-Virion Influenza Vaccine Administered by the Intradermal Route Compared with the Intramuscular Reference Vaccine Vaxigrip® in the Elderly

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    End point title
    		 Geometric Mean Titers of Influenza Antibodies Before and After Vaccination with Investigational Inactivated, Split-Virion Influenza Vaccine Administered by the Intradermal Route Compared with the Intramuscular Reference Vaccine Vaxigrip® in the Elderly
    End point description
    Immunogenicity was assessed using the hemagglutination inhibition (HI) technique.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 post-vaccination
    End point values
    		 ID 15μg IM 15μg
    Number of subjects analysed
    2600
    1077
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        A/New Caledonia/20/99 (H1N1; Day 0)
    20.6 (19.6 to 21.5)
    21.7 (20.2 to 23.3)
        A/Wisconsin/67/2005 (H3N2; Day 0)
    36.3 (34.2 to 38.6)
    33.8 (30.8 to 37.2)
        B/Malaysia/2506/2004 (Day 0)
    11 (10.7 to 11.4)
    11.5 (10.9 to 12.1)
        A/New Caledonia/20/99 (H1N1; Day 21)
    81.9 (78.2 to 85.8)
    69.1 (64.1 to 74.4)
        A/Wisconsin/67/2005 (H3N2; Day 21)
    298 (282 to 315)
    181 (167 to 197)
        B/Malaysia/2506/2004 (Day 21)
    39.9 (38.2 to 41.6)
    34.9 (32.7 to 37.3)
    Statistical analysis title
    		 Non-inferiority of ID Group for A/H3N2 Strain
    Statistical analysis description
    The non-inferiority of the ID investigational vaccine was assessed based on analysis performed on the Per Protocol Immunogenicity (PPI) population on each strain (A/H3N2, A/H1N1, and B).
    Comparison groups
    IM 15μg v ID 15μg
    Number of subjects included in analysis
    3677
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    		 Logrank
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.076
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.038
         upper limit
    		 0.114
    Notes
    [1] - Non-inferiority if for each strain, the two-sided 95% CI of the log difference of the geometric mean titers ID-IM lies above -0.176.
    Statistical analysis title
    		 Non-inferiority of ID Group for A/H1N1
    Statistical analysis description
    The non-inferiority of the ID investigational vaccine was assessed based on analysis performed on the Per Protocol Immunogenicity (PPI) population on each strain (A/H3N2, A/H1N1, and B).
    Comparison groups
    ID 15μg v IM 15μg
    Number of subjects included in analysis
    3677
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    		 Logrank
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.215
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.171
         upper limit
    		 0.259
    Notes
    [2] - Non-inferiority if for each strain, the two-sided 95% CI of the log difference of the geometric mean titers ID-IM lies above -0.176.
    Statistical analysis title
    		 Non-inferiority of ID Group for B
    Statistical analysis description
    The non-inferiority of the ID investigational vaccine was assessed based on analysis performed on the Per Protocol Immunogenicity (PPI) population on each strain (A/H3N2, A/H1N1, and B).
    Comparison groups
    ID 15μg v IM 15μg
    Number of subjects included in analysis
    3677
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    		 Logrank
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.026
         upper limit
    		 0.094
    Notes
    [3] - Non-inferiority if for each strain, the two-sided 95% CI of the log difference of the geometric mean titers ID-IM lies above -0.176.

    Primary: Percentage of Elderly Subjects With Seroprotection After Vaccination Against Investigational Inactivated, Split-Virion Influenza Vaccine Administered by the Intradermal Route Compared with the Intramuscular Reference Vaccine Vaxigrip®

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    End point title
    		 Percentage of Elderly Subjects With Seroprotection After Vaccination Against Investigational Inactivated, Split-Virion Influenza Vaccine Administered by the Intradermal Route Compared with the Intramuscular Reference Vaccine Vaxigrip®
    End point description
    Immunogenicity was assessed using the hemagglutination inhibition (HI) technique. Seroprotection was defined as HI antibody individual titer ≥40 (1/dil) 21 days (Day 21) after the first vaccination.
    End point type
    Primary
    End point timeframe
    Day 21 post-vaccination
    End point values
    		 ID 15μg IM 15μg
    Number of subjects analysed
    2595
    1078
    Units: Percentage of subjects
    number (not applicable)
        A/New Caledonia/20/99 (H1N1)
    77
    71.2
        A/Wisconsin/67/2005 (H3N2)
    93.3
    87.8
        B/Malaysia/2506/2004
    55.7
    49.1
    Statistical analysis title
    		 Superiority of ID investigational vaccine A/H1N1
    Statistical analysis description
    Superiority of the ID investigational vaccine was assessed, using the Full Analysis Set for Immunogenicity (FASI) population. Superiority if for at least two strains, the two-sided 95% CI of the difference of the seroprotection rate ID-IM lies above 0.
    Comparison groups
    ID 15μg v IM 15μg
    Number of subjects included in analysis
    3673
    Analysis specification
    Pre-specified
    Analysis type
    		 [4]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    5.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.67
         upper limit
    		 8.97
    Notes
    [4] - For each vaccine strain, A/H1N1, A/H3N2, and B the primary parameter was the difference of the seroprotection rates between the vaccine groups. The ID group was considered as superior to the IM control group if the hypothesis H0 was rejected for at least two strains, after having confirmed the non-inferiority in terms of post-vaccination GMT for all 3 strains.
    Statistical analysis title
    		 Superiority of ID investigational vaccine A/H3N2
    Statistical analysis description
    Superiority of the ID investigational vaccine was assessed, using the Full Analysis Set for Immunogenicity (FASI) population. Superiority if for at least two strains, the two-sided 95% CI of the difference of the seroprotection rate ID-IM lies above 0.
    Comparison groups
    ID 15μg v IM 15μg
    Number of subjects included in analysis
    3673
    Analysis specification
    Pre-specified
    Analysis type
    		 [5]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    5.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.4
         upper limit
    		 7.76
    Notes
    [5] - For each vaccine strain, A/H1N1, A/H3N2, and B the primary parameter was the difference of the seroprotection rates between the vaccine groups. The ID group was considered as superior to the IM control group if the hypothesis H0 was rejected for at least two strains, after having confirmed the non-inferiority in terms of post-vaccination GMT for all 3 strains.
    Statistical analysis title
    		 Superiority of ID investigational vaccine B
    Statistical analysis description
    Superiority of the ID investigational vaccine was assessed, using the Full Analysis Set for Immunogenicity (FASI) population. Superiority if for at least two strains, the two-sided 95% CI of the difference of the seroprotection rate ID-IM lies above 0.
    Comparison groups
    ID 15μg v IM 15μg
    Number of subjects included in analysis
    3673
    Analysis specification
    Pre-specified
    Analysis type
    		 [6]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    6.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.05
         upper limit
    		 10.1
    Notes
    [6] - For each vaccine strain, A/H1N1, A/H3N2, and B the primary parameter was the difference of the seroprotection rates between the vaccine groups. The ID group was considered as superior to the IM control group if the hypothesis H0 was rejected for at least two strains, after having confirmed the non-inferiority in terms of post-vaccination GMT for all 3 strains.

    Secondary: Geometric Mean Titers of Influenza Antibodies Before and After Vaccination with Investigational Inactivated, Split-Virion Influenza Vaccine Administered by the Intradermal Route Compared with the Intramuscular Reference Vaccine Vaxigrip® in the Elderly

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    End point title
    		 Geometric Mean Titers of Influenza Antibodies Before and After Vaccination with Investigational Inactivated, Split-Virion Influenza Vaccine Administered by the Intradermal Route Compared with the Intramuscular Reference Vaccine Vaxigrip® in the Elderly
    End point description
    Immunogenicity was assessed using the hemagglutination inhibition (HI) technique.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 post-vaccination
    End point values
    		 ID 15μg IM 15μg
    Number of subjects analysed
    2586
    1077
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        A/New Caledonia/20/99 (H1N1; Day 0)
    20.6 (19.7 to 21.5)
    21.6 (20.1 to 23.2)
        A/Wisconsin/67/2005 (H3N2; Day 0)
    36.3 (34.2 to 38.6)
    33.9 (30.8 to 37.2)
        B/Malaysia/2506/2004 (Day 0)
    11 (10.7 to 11.4)
    11.5 (10.9 to 12.1)
        A/New Caledonia/20/99 (H1N1; Day 21)
    81.7 (78 to 85.6)
    68.8 (63.8 to 74.2)
        A/Wisconsin/67/2005 (H3N2; Day 21)
    298 (282 to 315)
    181 (167 to 197)
        B/Malaysia/2506/2004 (Day 21)
    39.9 (38.3 to 41.6)
    34.8 (32.6 to 37.2)
    No statistical analyses for this end point

    Secondary: Percentage of Elderly Subjects With Seroprotection Against Influenza Antigens Before and After Investigational Inactivated, Split-Virion Influenza Vaccine Administered by the Intradermal Route Compared with the Intramuscular Reference Vaccine Vaxigrip®

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    End point title
    		 Percentage of Elderly Subjects With Seroprotection Against Influenza Antigens Before and After Investigational Inactivated, Split-Virion Influenza Vaccine Administered by the Intradermal Route Compared with the Intramuscular Reference Vaccine Vaxigrip®
    End point description
    Immunogenicity was assessed using the hemagglutination inhibition (HI) technique. Seroprotection was defined as HI antibody individual titer ≥40 (1/dil) 21 days (Day 21) after the first vaccination.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 post-vaccination
    End point values
    		 ID 15μg IM 15μg
    Number of subjects analysed
    2586
    1077
    Units: Percentage of subjects
    number (not applicable)
        A/New Caledonia/20/99 (H1N1; Day 0)
    32.5
    33.8
        A/Wisconsin/67/2005 (H3N2; Day 0)
    48.9
    47
        B/Malaysia/2506/2004 (Day 0)
    12
    12.4
        A/New Caledonia/20/99 (H1N1; Day 21)
    77
    71.1
        A/Wisconsin/67/2005 (H3N2; Day 21)
    93.3
    87.9
        B/Malaysia/2506/2004 (Day 21)
    55.7
    48.9
    No statistical analyses for this end point

    Secondary: Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies After Vaccination with Investigational Inactivated, Split-Virion Influenza Vaccine Administered by the Intradermal Route Compared with the Intramuscular Reference Vaccine Vaxigrip® in the Elderly

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    End point title
    		 Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies After Vaccination with Investigational Inactivated, Split-Virion Influenza Vaccine Administered by the Intradermal Route Compared with the Intramuscular Reference Vaccine Vaxigrip® in the Elderly
    End point description
    Immunogenicity was assessed using the hemagglutination inhibition (HI) technique.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 post-vaccination
    End point values
    		 ID 15μg IM 15μg
    Number of subjects analysed
    2586
    1077
    Units: Titers Ratios
    geometric mean (confidence interval 95%)
        A/New Caledonia/20/99 (H1N1)
    3.97 (3.77 to 4.18)
    3.19 (2.94 to 3.45)
        A/Wisconsin/67/2005 (H3N2)
    8.19 (7.68 to 8.74)
    5.35 (4.87 to 5.88)
        B/Malaysia/2506/2004
    3.61 (3.47 to 3.76)
    3.04 (2.85 to 3.24)
    No statistical analyses for this end point

    Secondary: Percentage of Elderly Subjects Achieving Seroconversion or Significant increase in Influenza Antibodies After Investigational Inactivated, Split-Virion Influenza Vaccine Administered by the Intradermal Route Compared with Intramuscular Vaccine Vaxigrip®

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    End point title
    		 Percentage of Elderly Subjects Achieving Seroconversion or Significant increase in Influenza Antibodies After Investigational Inactivated, Split-Virion Influenza Vaccine Administered by the Intradermal Route Compared with Intramuscular Vaccine Vaxigrip®
    End point description
    Immunogenicity was assessed using the hemagglutination inhibition (HI) technique. Seroconversion was defined as subjects with a pre-vaccination HI antibody individual titer <10 (1/dil) and post-vaccination HI antibody individual titer ≥40 (1/dil) and significant increase defined as subjects with a pre-vaccination HI antibody individual titer ≥10 (1/dil): ≥ four-fold increase from pre- to post-vaccination HI antibody individual titer on Day 21.
    End point type
    Secondary
    End point timeframe
    Day 21 post-vaccination
    End point values
    		 ID 15μg IM 15μg
    Number of subjects analysed
    2586
    1077
    Units: Percentage of subjects
    number (not applicable)
        A/New Caledonia/20/99 (H1N1)
    38.7
    30
        A/Wisconsin/67/2005 (H3N2)
    61.3
    46.9
        B/Malaysia/2506/2004
    36.4
    30.7
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers of Influenza Antibodies Before and Up to 12 Months After Investigational Inactivated, Split-Virion Influenza Vaccine Administered by the Intradermal Route Compared with the Intramuscular Reference Vaccine Vaxigrip® in the Elderly

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    End point title
    		 Geometric Mean Titers of Influenza Antibodies Before and Up to 12 Months After Investigational Inactivated, Split-Virion Influenza Vaccine Administered by the Intradermal Route Compared with the Intramuscular Reference Vaccine Vaxigrip® in the Elderly
    End point description
    Immunogenicity was assessed using the hemagglutination inhibition (HI) technique. This outcome was based on the Other Immunogenicity (OI) Analysis Set.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 post-vaccination
    End point values
    		 ID 15μg IM 15μg
    Number of subjects analysed
    128
    141
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        A/New Caledonia/20/99 (H1N1; Day 0)
    23.5 (19.2 to 28.9)
    24.5 (19.8 to 30.4)
        A/Wisconsin/67/2005 (H3N2; Day 0)
    35.9 (26.8 to 48)
    33.2 (25.6 to 43)
        B/Malaysia/2506/2004 (Day 0)
    11.4 (9.78 to 13.2)
    11.4 (9.8 to 13.2)
        A/New Caledonia/20/99 (H1N1; Day 21)
    93.9 (77.6 to 114)
    72.3 (59.4 to 88.1)
        A/Wisconsin/67/2005 (H3N2; Day 21)
    301 (239 to 378)
    197 (160 to 243)
        B/Malaysia/2506/2004 (Day 21)
    42.3 (35.8 to 50.1)
    39 (31.8 to 47.9)
        A/New Caledonia/20/99 (H1N1; Day 90)
    71 (59.5 to 84.7)
    61.2 (50.8 to 73.7)
        A/Wisconsin/67/2005 (H3N2; Day 90)
    291 (233 to 363)
    208 (167 to 258)
        B/Malaysia/2506/2004 (Day 90)
    27.3 (22.8 to 32.6)
    28.3 (23.5 to 34)
        A/New Caledonia/20/99 (H1N1; Day 180)
    50.2 (42 to 60.1)
    49.3 (40.5 to 60)
        A/Wisconsin/67/2005 (H3N2; Day 180)
    226 (179 to 286)
    169 (134 to 212)
        B/Malaysia/2506/2004 (Day 180)
    21.6 (18.1 to 25.7)
    24.6 (20.7 to 29.2)
        A/New Caledonia/20/99 (H1N1; Day 365)
    30.9 (26.3 to 36.4)
    31 (25.7 to 37.3)
        A/Wisconsin/67/2005 (H3N2; Day 365)
    119 (92.8 to 151)
    98.4 (79 to 122)
        B/Malaysia/2506/2004 (Day 365)
    22.1 (18.7 to 26.1)
    26.1 (22.1 to 30.7)
    No statistical analyses for this end point

    Secondary: Percentage of Elderly Subjects With Seroprotection Before and up to 12 Months After Investigational Inactivated, Split-Virion Influenza Vaccine Administered by the Intradermal Route Compared with the Intramuscular Reference Vaccine Vaxigrip®

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    End point title
    		 Percentage of Elderly Subjects With Seroprotection Before and up to 12 Months After Investigational Inactivated, Split-Virion Influenza Vaccine Administered by the Intradermal Route Compared with the Intramuscular Reference Vaccine Vaxigrip®
    End point description
    Immunogenicity was assessed using the hemagglutination inhibition (HI) technique. Seroprotection was defined as HI antibody individual titer ≥40 (1/dil) on 21, 90, 180, and 365 days after the first vaccination. This outcome was based on the Other Immunogenicity (OI) Analysis Set.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21, 90, 180, and 365 post-vaccination
    End point values
    		 ID 15μg IM 15μg
    Number of subjects analysed
    128
    141
    Units: Percentage of subjects
    number (not applicable)
        A/New Caledonia/20/99 (H1N1; Day 0)
    36.7
    35.5
        A/Wisconsin/67/2005 (H3N2; Day 0)
    44.9
    48.9
        B/Malaysia/2506/2004 (Day 0)
    12.5
    14.2
        A/New Caledonia/20/99 (H1N1; Day 21)
    83.6
    73.8
        A/Wisconsin/67/2005 (H3N2; Day 21)
    96.1
    92.1
        B/Malaysia/2506/2004 (Day 21)
    61.7
    53.9
        A/New Caledonia/20/99 (H1N1; Day 90)
    74.2
    66.7
        A/Wisconsin/67/2005 (H3N2; Day 90)
    96.1
    92.1
        B/Malaysia/2506/2004 (Day 90)
    41.4
    39
        A/New Caledonia/20/99 (H1N1; Day 180)
    62.5
    59.6
        A/Wisconsin/67/2005 (H3N2; Day 180)
    95.3
    85.6
        B/Malaysia/2506/2004 (Day 180)
    30.5
    34
        A/New Caledonia/20/99 (H1N1; Day 365)
    44.5
    42.6
        A/Wisconsin/67/2005 (H3N2; Day 365)
    81.1
    79.1
        B/Malaysia/2506/2004 (Day 365)
    30.5
    38.3
    No statistical analyses for this end point

    Secondary: Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies up to 12 Months After Investigational Inactivated, Split-Virion Influenza Vaccine Administered by the Intradermal Route Compared with the Intramuscular Reference Vaccine Vaxigrip in the Elderly

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    End point title
    		 Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies up to 12 Months After Investigational Inactivated, Split-Virion Influenza Vaccine Administered by the Intradermal Route Compared with the Intramuscular Reference Vaccine Vaxigrip in the Elderly
    End point description
    Immunogenicity was assessed using the hemagglutination inhibition (HI) technique. This outcome was based on the Other Immunogenicity (OI) Analysis Set.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21, 90, 180, and 365 post-vaccination
    End point values
    		 ID 15μg IM 15μg
    Number of subjects analysed
    128
    141
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        A/New Caledonia/20/99 (H1N1; Day 90/Day 21)
    0.757 (0.692 to 0.827)
    0.846 (0.779 to 0.919)
        A/Wisconsin/67/2005 (H3N2; Day 90/Day 21)
    0.968 (0.869 to 1.08)
    1.06 (0.969 to 1.15)
        B/Malaysia/2506/2004 (Day 90/Day 21)
    0.645 (0.579 to 0.718)
    0.725 (0.658 to 0.798)
        A/New Caledonia/20/99 (H1N1; Day 180/Day 21)
    0.535 (0.476 to 0.602)
    0.682 (0.617 to 0.753)
        A/Wisconsin/67/2005 (H3N2; Day 180/Day 21)
    0.753 (0.638 to 0.889)
    0.859 (0.74 to 0.997)
        B/Malaysia/2506/2004 (Day 180/Day 21)
    0.51 (0.45 to 0.578)
    0.63 (0.563 to 0.705)
        A/New Caledonia/20/99 (H1N1; Day 365/Day 21)
    0.33 (0.284 to 0.382)
    0.428 (0.376 to 0.488)
        A/Wisconsin/67/2005 (H3N2; Day 365/Day 21)
    0.394 (0.327 to 0.476)
    0.5 (0.426 to 0.586)
        B/Malaysia/2506/2004 (Day 365/Day 21)
    0.522 (0.458 to 0.595)
    0.668 (0.586 to 0.763)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers of Influenza Antibodies According to EMEA Parameters Before and After Investigational Inactivated, Split-Virion Influenza Vaccine Administered by the Intradermal Route Compared with Intramuscular Vaccine Vaxigrip® in the Elderly

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    End point title
    		 Geometric Mean Titers of Influenza Antibodies According to EMEA Parameters Before and After Investigational Inactivated, Split-Virion Influenza Vaccine Administered by the Intradermal Route Compared with Intramuscular Vaccine Vaxigrip® in the Elderly
    End point description
    Immunogenicity was assessed using the hemagglutination inhibition (HI) technique. This outcome was based on the Other Immunogenicity (OI) Analysis Set.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 post-vaccination
    End point values
    		 ID 15μg IM 15μg
    Number of subjects analysed
    262
    143
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        A/Solomon Islands/3/2006 (H1N1; Day 0)
    20.8 (18.2 to 23.7)
    19 (15.6 to 23)
        A/Wisconsin/67/2005 (H3N2; Day 0)
    112 (94.4 to 132)
    102 (81.8 to 127)
        B/Malaysia/2506/2004 (Day 0)
    24.3 (21.6 to 27.3)
    22.4 (19.3 to 25.9)
        A/Solomon Islands/3/2006 (H1N1; Day 21)
    204 (175 to 239)
    137 (108 to 175)
        A/Wisconsin/67/2005 (H3N2; Day 21)
    382 (334 to 438)
    293 (240 to 357)
        B/Malaysia/2506/2004 (Day 21)
    46.2 (41.4 to 51.6)
    37.4 (32 to 43.7)
    No statistical analyses for this end point

    Secondary: Percentage of Elderly Subjects With Seroprotection According to EMEA Parameters After Investigational Inactivated, Split-Virion Influenza Vaccine Administered by the Intradermal Route Compared with the Intramuscular Reference Vaccine Vaxigrip®

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    End point title
    		 Percentage of Elderly Subjects With Seroprotection According to EMEA Parameters After Investigational Inactivated, Split-Virion Influenza Vaccine Administered by the Intradermal Route Compared with the Intramuscular Reference Vaccine Vaxigrip®
    End point description
    Immunogenicity was assessed using the hemagglutination inhibition (HI) technique. This outcome was based on the Other Immunogenicity (OI) Analysis Set. Seroprotection was defined as HI antibody individual titer ≥40 (1/dil) with EMEA immunogenicity criteria >60% 21 days (Day 21) after the first vaccination.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 post-vaccination
    End point values
    		 ID 15μg IM 15μg
    Number of subjects analysed
    262
    143
    Units: Percentage of subjects
    number (not applicable)
        A/Solomon Islands/3/2006 (H1N1; Day 0)
    29.1
    25.9
        A/Wisconsin/67/2005 (H3N2; Day 0)
    80.3
    80.3
        B/Malaysia/2506/2004 (Day 0)
    34.4
    35
        A/Solomon Islands/3/2006 (H1N1; Day 21)
    93.1
    81.8
        A/Wisconsin/67/2005 (H3N2; Day 21)
    98.1
    95.8
        B/Malaysia/2506/2004 (Day 21)
    59.9
    53.1
    No statistical analyses for this end point

    Secondary: Percentage of Elderly Subjects Achieving Seroconversion or Significant increase in Influenza Antibodies According to EMEA After Inactivated, Split-Virion Influenza Vaccine Administered by the Intradermal Route Compared with Intramuscular Vaccine Vaxigrip®

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    End point title
    		 Percentage of Elderly Subjects Achieving Seroconversion or Significant increase in Influenza Antibodies According to EMEA After Inactivated, Split-Virion Influenza Vaccine Administered by the Intradermal Route Compared with Intramuscular Vaccine Vaxigrip®
    End point description
    Immunogenicity was assessed using the hemagglutination inhibition (HI) technique. This outcome was based on the Other Immunogenicity (OI) Analysis Set. Seroconversion was defined as subjects with a pre-vaccination HI antibody individual titer <10 (1/dil) and post-vaccination HI antibody individual titer ≥40 (1/dil) and significant increase defined as subjects with a pre-vaccination HI antibody individual titer ≥10 (1/dil): ≥ four-fold increase from pre- to post-vaccination HI antibody individual titer on Day 21 with EMEA immunogenicity criteria >30%.
    End point type
    Secondary
    End point timeframe
    Day 21 post-vaccination
    End point values
    		 ID 15μg IM 15μg
    Number of subjects analysed
    262
    143
    Units: Percentage of subjects
    number (not applicable)
        A/Solomon Islands/3/2006 (H1N1)
    76.2
    63.6
        A/Wisconsin/67/2005 (H3N2)
    45.9
    40.1
        B/Malaysia/2506/2004
    17.2
    9.8
    No statistical analyses for this end point

    Secondary: Geometric Mean Titer Ratios of Influenza Antibodies According to EMEA Parameters After Investigational Inactivated, Split-Virion Influenza Vaccine Administered by the Intradermal Route Compared with the Intramuscular Vaccine Vaxigrip® in the Elderly

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    End point title
    		 Geometric Mean Titer Ratios of Influenza Antibodies According to EMEA Parameters After Investigational Inactivated, Split-Virion Influenza Vaccine Administered by the Intradermal Route Compared with the Intramuscular Vaccine Vaxigrip® in the Elderly
    End point description
    Immunogenicity was assessed using the hemagglutination inhibition (HI) technique. This outcome was based on the Other Immunogenicity (OI) Analysis Set. Based on EMEA immunogenicity criteria, the mean geometric increase between Day 0 and Day 21 was 2.0.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 post-vaccination
    End point values
    		 ID 15μg IM 15μg
    Number of subjects analysed
    262
    143
    Units: Titer Ratios
    geometric mean (confidence interval 95%)
        A/Solomon Islands/3/2006 (H1N1)
    9.84 (8.43 to 11.5)
    7.24 (5.82 to 9.02)
        A/Wisconsin/67/2005 (H3N2)
    3.42 (2.99 to 3.91)
    2.88 (2.43 to 3.41)
        B/Malaysia/2506/2004
    1.9 (1.75 to 2.07)
    1.67 (1.5 to 1.86)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers of Antibodies According to EMEA Before and After Third Vaccination with Investigational Inactivated, Split-Virion Influenza Vaccine Administered by the Intradermal Route Compared with Intramuscular Vaccine Vaxigrip® in the Elderly

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    End point title
    		 Geometric Mean Titers of Antibodies According to EMEA Before and After Third Vaccination with Investigational Inactivated, Split-Virion Influenza Vaccine Administered by the Intradermal Route Compared with Intramuscular Vaccine Vaxigrip® in the Elderly
    End point description
    Immunogenicity was assessed using the hemagglutination inhibition (HI) technique. This outcome was based on the Other Immunogenicity (OI) Analysis Set.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 post-vaccination
    End point values
    		 ID 15μg IM 15μg
    Number of subjects analysed
    298
    67
    Units: Titers (1/dil)
    geometric mean (confidence interval 95%)
        A/Brisbane/59/2007 (H1N1; Day 0)
    25.8 (22.7 to 29.2)
    20.7 (16.5 to 26.1)
        A/Uruguay/716/2007 (H3N2; Day 0)
    18.6 (16.4 to 21.1)
    15.5 (11.7 to 20.7)
        B/Florida/4/2006 (Day 0)
    14.7 (13.2 to 16.3)
    16.9 (13.2 to 21.6)
        A/Brisbane/59/2007 (H1N1; Day 21)
    73.5 (65.3 to 82.7)
    59.3 (44.4 to 79.2)
        A/Uruguay/716/2007 (H3N2; Day 21)
    144 (124 to 166)
    108 (75.6 to 154)
        B/Florida/4/2006 (Day 21)
    46.5 (41.4 to 52.2)
    40.4 (32.3 to 50.5)
    No statistical analyses for this end point

    Secondary: Percentage of Elderly Subjects With Seroprotection According to EMEA After Third Vaccination Against Investigational Inactivated, Split-Virion Influenza Vaccine Administered by the Intradermal Route Compared with the Intramuscular Vaccine Vaxigrip®

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    End point title
    		 Percentage of Elderly Subjects With Seroprotection According to EMEA After Third Vaccination Against Investigational Inactivated, Split-Virion Influenza Vaccine Administered by the Intradermal Route Compared with the Intramuscular Vaccine Vaxigrip®
    End point description
    Immunogenicity was assessed using the hemagglutination inhibition (HI) technique. This outcome was based on the Other Immunogenicity (OI) Analysis Set. Seroprotection was defined as HI antibody individual titer ≥40 (1/dil) with EMEA immunogenicity criteria >60% 21 days (Day 21) after the first vaccination.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 post-vaccination
    End point values
    		 ID 15μg IM 15μg
    Number of subjects analysed
    298
    67
    Units: Percentage of subjects
    number (not applicable)
        A/Brisbane/59/2007 (H1N1; Day 0)
    38.9
    30.3
        A/Uruguay/716/2007 (H3N2; Day 0)
    29.5
    24.2
        B/Florida/4/2006 (Day 0)
    21.1
    25.4
        A/Brisbane/59/2007 (H1N1; Day 21)
    80.5
    74.2
        A/Uruguay/716/2007 (H3N2; Day 21)
    89.6
    77.3
        B/Florida/4/2006 (Day 21)
    66.1
    55.2
    No statistical analyses for this end point

    Secondary: Percentage of Elderly Subjects Achieving Seroconversion or Significant increase in Antibodies According to EMEA After Third Vaccination of Intradermal Inactivated, Split-Virion Influenza Vaccine Compared with the Intramuscular Vaccine Vaxigrip®

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    End point title
    		 Percentage of Elderly Subjects Achieving Seroconversion or Significant increase in Antibodies According to EMEA After Third Vaccination of Intradermal Inactivated, Split-Virion Influenza Vaccine Compared with the Intramuscular Vaccine Vaxigrip®
    End point description
    Immunogenicity was assessed using the hemagglutination inhibition (HI) technique. This outcome was based on the Other Immunogenicity (OI) Analysis Set. Seroconversion was defined as subjects with a pre-vaccination HI antibody individual titer <10 (1/dil) and post-vaccination HI antibody individual titer ≥40 (1/dil) and significant increase defined as subjects with a pre-vaccination HI antibody individual titer ≥10 (1/dil): ≥ four-fold increase from pre- to post-vaccination HI antibody individual titer on Day 21 with EMEA immunogenicity criteria >30%.
    End point type
    Secondary
    End point timeframe
    Day 21 post-vaccination
    End point values
    		 ID 15μg IM 15μg
    Number of subjects analysed
    298
    67
    Units: Percentage of subjects
    number (not applicable)
        A/Brisbane/59/2007 (H1N1)
    35.2
    31.8
        A/Uruguay/716/2007 (H3N2)
    71.8
    60.6
        B/Florida/4/2006
    37.2
    26.9
    No statistical analyses for this end point

    Secondary: Geometric Mean Titer Ratios of Antibodies According to EMEA After Third Vaccination with Investigational Inactivated, Split-Virion Influenza Vaccine Administered by the Intradermal Route Compared with the Intramuscular Vaccine Vaxigrip® in the Elderly

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    End point title
    		 Geometric Mean Titer Ratios of Antibodies According to EMEA After Third Vaccination with Investigational Inactivated, Split-Virion Influenza Vaccine Administered by the Intradermal Route Compared with the Intramuscular Vaccine Vaxigrip® in the Elderly
    End point description
    Immunogenicity was assessed using the hemagglutination inhibition (HI) technique. This outcome was based on the Other Immunogenicity (OI) Analysis Set. Based on EMEA immunogenicity criteria, the mean geometric increase between Day 0 and Day 21 was 2.0.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 post-vaccination
    End point values
    		 ID 15μg IM 15μg
    Number of subjects analysed
    298
    67
    Units: Titer Ratios
    geometric mean (confidence interval 95%)
        A/Brisbane/59/2007 (H1N1)
    2.85 (2.56 to 3.17)
    2.86 (2.31 to 3.54)
        A/Uruguay/716/2007 (H3N2)
    7.74 (6.77 to 8.85)
    6.94 (5.15 to 9.36)
        B/Florida/4/2006
    3.16 (2.84 to 3.52)
    2.4 (1.93 to 2.98)
    No statistical analyses for this end point

    Secondary: Percentage of Elderly Subjects Reporting Solicited Reactions Listed in the EMEA Note for Guidance Within 3 Days after the First Vaccination with Intradermal Inactivated, Split-Virion Influenza Vaccine Compared with the Intramuscular Vaccine Vaxigrip®

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    End point title
    		 Percentage of Elderly Subjects Reporting Solicited Reactions Listed in the EMEA Note for Guidance Within 3 Days after the First Vaccination with Intradermal Inactivated, Split-Virion Influenza Vaccine Compared with the Intramuscular Vaccine Vaxigrip®
    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
    Secondary
    End point timeframe
    Day 0 up to Day 3 post-first vaccination
    End point values
    		 ID 15μg IM 15μg
    Number of subjects analysed
    2606
    1089
    Units: Percentage of subjects
    number (not applicable)
        At least 1 reaction listed in EMEA recommendations
    12.6
    12.8
        Injection site induration >5 cm for 3 days
    0.1
    0
        Injection site ecchymosis
    2.8
    3
        Pyrexia (rectal temperature > 38°C) for ≥24 hours
    1.1
    1.4
        Malaise
    7.6
    6.8
        Shivering
    3.9
    4.6
    No statistical analyses for this end point

    Secondary: Percentage of Elderly Subjects Reporting Solicited Reactions Listed in the EMEA Note for Guidance Within 3 Days after the Second Vaccination with Intradermal Inactivated, Split-Virion Influenza Vaccine Compared with the Intramuscular Vaccine Vaxigrip®

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    End point title
    		 Percentage of Elderly Subjects Reporting Solicited Reactions Listed in the EMEA Note for Guidance Within 3 Days after the Second Vaccination with Intradermal Inactivated, Split-Virion Influenza Vaccine Compared with the Intramuscular Vaccine Vaxigrip®
    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
    Secondary
    End point timeframe
    Day 0 up to Day 3 post-second vaccination
    End point values
    		 ID 15μg IM 15μg
    Number of subjects analysed
    2618 [7]
    511
    Units: Percentage of subjects
    number (not applicable)
        At least 1 reaction listed in EMEA recommendations
    12.2
    12
        Injection site induration >5 cm for 3 days
    0.1
    0
        Injection site ecchymosis
    2.7
    3
        Pyrexia (rectal temperature > 38°C) for ≥24 hours
    2
    2.2
        Malaise
    5.9
    5.5
        Shivering
    4.6
    4.7
    Notes
    [7] - The total number of subjects analyzed was 2965 and was based on the Safety Analyis Set population.
    No statistical analyses for this end point

    Secondary: Percentage of Elderly Subjects Reporting Solicited Reactions Listed in the EMEA Note for Guidance Within 3 Days after the Third Vaccination with Intradermal Inactivated, Split-Virion Influenza Vaccine Compared with the Intramuscular Vaccine Vaxigrip®

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    End point title
    		 Percentage of Elderly Subjects Reporting Solicited Reactions Listed in the EMEA Note for Guidance Within 3 Days after the Third Vaccination with Intradermal Inactivated, Split-Virion Influenza Vaccine Compared with the Intramuscular Vaccine Vaxigrip®
    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
    Secondary
    End point timeframe
    Day 0 up to Day 3 post-third vaccination
    End point values
    		 ID 15μg IM 15μg
    Number of subjects analysed
    2618 [8]
    229
    Units: Percentage of subjects
    number (not applicable)
        At least 1 reaction listed in EMEA recommendations
    11.8
    12.3
        Injection site induration >5 cm for 3 days
    0
    0
        Injection site ecchymosis
    2.9
    1.8
        Pyrexia (rectal temperature > 38°C) for ≥24 hours
    2.8
    1.8
        Malaise
    4.6
    5.7
        Shivering
    4.4
    4.8
    Notes
    [8] - The total number of subjects analyzed was 2920 and was based on the Safety Analyis Set population.
    No statistical analyses for this end point

    Secondary: Percentage of Elderly Subjects Reporting Solicited Injection-site or Systemic Reaction Within 7 Days After First Vaccination with Intradermal Inactivated, Split-Virion Influenza Vaccine Compared with the Intramuscular Reference Vaccine Vaxigrip®

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    End point title
    		 Percentage of Elderly Subjects Reporting Solicited Injection-site or Systemic Reaction Within 7 Days After First Vaccination with Intradermal Inactivated, Split-Virion Influenza Vaccine Compared with the Intramuscular Reference Vaccine Vaxigrip®
    End point description
    Solicited injection site: Pain, Pruritus, Erythema, Swelling, Induration and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering.
    End point type
    Secondary
    End point timeframe
    Day 0 up to Day 7 post-first vaccination
    End point values
    		 ID 15μg IM 15μg
    Number of subjects analysed
    2606
    1089
    Units: Percentage of subjects
    number (not applicable)
        Injection site Pain
    22.7
    17.2
        Injection site Pruritus
    29.5
    6.1
        Injection site Erythema
    70.9
    15.1
        Injection site Swelling
    35.8
    8.4
        Injection site Induration
    37.6
    11.3
        Injection site Ecchymosis
    3.4
    3.7
        Fever
    2.5
    3.4
        Headache
    13
    12.7
        Malaise
    8.5
    7.8
        Myalgia
    10.6
    10.9
        Shivering
    4.6
    6.1
    No statistical analyses for this end point

    Secondary: Percentage of Elderly Subjects Reporting Solicited Injection-site or Systemic Reaction Within 7 Days After Second Vaccination with Intradermal Inactivated, Split-Virion Influenza Vaccine Compared with the Intramuscular Reference Vaccine Vaxigrip®

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    End point title
    		 Percentage of Elderly Subjects Reporting Solicited Injection-site or Systemic Reaction Within 7 Days After Second Vaccination with Intradermal Inactivated, Split-Virion Influenza Vaccine Compared with the Intramuscular Reference Vaccine Vaxigrip®
    End point description
    Solicited injection site: Pain, Pruritus, Erythema, Swelling, Induration and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering.
    End point type
    Secondary
    End point timeframe
    Day 0 up to Day 7 post-second vaccination
    End point values
    		 ID 15μg IM 15μg
    Number of subjects analysed
    2618 [9]
    511
    Units: Percentage of subjects
    number (not applicable)
        Injection site Pain
    23.1
    18.9
        Injection site Pruritus
    27.5
    8.9
        Injection site Erythema
    62.8
    19.9
        Injection site Swelling
    32.5
    10
        Injection site Induration
    32.7
    11.2
        Injection site Ecchymosis
    3.3
    3.1
        Fever
    3.7
    4.6
        Headache
    12.3
    10.6
        Malaise
    6.8
    7.3
        Myalgia
    11.5
    10.6
        Shivering
    5.4
    5.5
    Notes
    [9] - The total number of subjects analyzed was 2965 and was based on the Safety Analyis Set population.
    No statistical analyses for this end point

    Secondary: Percentage of Elderly Subjects Reporting Solicited Injection-site or Systemic Reaction Within 7 Days After Third Vaccination with Intradermal Inactivated, Split-Virion Influenza Vaccine Compared with the Intramuscular Reference Vaccine Vaxigrip®

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    End point title
    		 Percentage of Elderly Subjects Reporting Solicited Injection-site or Systemic Reaction Within 7 Days After Third Vaccination with Intradermal Inactivated, Split-Virion Influenza Vaccine Compared with the Intramuscular Reference Vaccine Vaxigrip®
    End point description
    Solicited injection site: Pain, Pruritus, Erythema, Swelling, Induration and Ecchymosis. Solicited systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering.
    End point type
    Secondary
    End point timeframe
    Day 0 up to Day 7 post-third vaccination
    End point values
    		 ID 15μg IM 15μg
    Number of subjects analysed
    2618 [10]
    229
    Units: Percentage of subjects
    number (not applicable)
        Injection site Pain
    20.5
    15.8
        Injection site Pruritus
    28.3
    7.5
        Injection site Erythema
    62.8
    18
        Injection site Swelling
    34.1
    12.3
        Injection site Induration
    31.5
    12.3
        Injection site Ecchymosis
    3.8
    2.2
        Fever
    5.2
    3.5
        Headache
    11.6
    9.2
        Malaise
    5.6
    7
        Myalgia
    10.3
    7.9
        Shivering
    5.2
    6.1
    Notes
    [10] - The total number of subjects analyzed was 2920 and was based on the Safety Analyis Set population.
    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-any vaccination.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    7.1
    Reporting groups
    Reporting group title
    IM 15μg
    Reporting group description
    		 Subjects who received 3 vaccinations of inactivated, split-virion (with octoxynol-9) influenza vaccine via the intramuscular (IM) route. For the first vaccination, subjects received the 2006-2007 Northern Hemisphere [NH] formulation on Day 0 (Year 0). For the second vaccination, subjects received the 2007-2008 NH formulation on Day 365 (Year 1). For the third vaccination, subjects received the 2008-2009 NH formulation on Day 730 (Year 2).

    Reporting group title
    ID 15μg
    Reporting group description
    		 Subjects who received 3 vaccinations of inactivated, split-virion (with octoxynol-9) investigational influenza vaccine via the intradermal (ID) route. For the first vaccination, subjects received the 2006-2007 Northern Hemisphere [NH] formulation on Day 0 (Year 0). For the second vaccination, subjects received the 2007-2008 NH formulation on Day 365 (Year 1). For the third vaccination, subjects received the 2008-2009 NH formulation on Day 730 (Year 2).

    Serious adverse events
    		 IM 15μg ID 15μg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    13 / 1089 (1.19%)
    32 / 2965 (1.08%)
         number of deaths (all causes)
    1
    2
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute myeloid leukaemia
         subjects affected / exposed [1]
    0 / 1089 (0.00%)
    1 / 2606 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Breast cancer female
         subjects affected / exposed [2]
    0 / 511 (0.00%)
    1 / 2965 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Colon cancer
         subjects affected / exposed [3]
    0 / 511 (0.00%)
    2 / 2965 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed [4]
    1 / 511 (0.20%)
    0 / 2965 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vocal cord neoplasm
         subjects affected / exposed [5]
    0 / 511 (0.00%)
    1 / 2965 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed [6]
    0 / 1089 (0.00%)
    1 / 2606 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed [7]
    0 / 511 (0.00%)
    1 / 2965 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Abnormal behaviour
         subjects affected / exposed [8]
    1 / 1089 (0.09%)
    0 / 2606 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anxiety disorder
         subjects affected / exposed [9]
    0 / 511 (0.00%)
    1 / 2965 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Personality disorder
         subjects affected / exposed [10]
    0 / 1089 (0.00%)
    1 / 2606 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Hand fracture
         subjects affected / exposed [11]
    0 / 1089 (0.00%)
    1 / 2606 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Polytraumatism
         subjects affected / exposed [12]
    1 / 1089 (0.09%)
    0 / 2606 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed [13]
    0 / 1089 (0.00%)
    1 / 2606 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wrist fracture
         subjects affected / exposed [14]
    0 / 511 (0.00%)
    1 / 2965 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed [15]
    0 / 1089 (0.00%)
    1 / 2606 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed [16]
    0 / 511 (0.00%)
    2 / 2965 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocardial infarction
         subjects affected / exposed
    2 / 1089 (0.18%)
    0 / 2965 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed [17]
    1 / 511 (0.20%)
    3 / 2965 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cervical root pain
         subjects affected / exposed [18]
    1 / 511 (0.20%)
    0 / 2965 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrocephalus
         subjects affected / exposed [19]
    0 / 511 (0.00%)
    1 / 2965 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed [20]
    0 / 1089 (0.00%)
    1 / 2606 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sciatica
         subjects affected / exposed [21]
    0 / 1089 (0.00%)
    1 / 2606 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Syncope vasovagal
         subjects affected / exposed [22]
    0 / 1089 (0.00%)
    1 / 2606 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Transient ischaemic attack
         subjects affected / exposed [23]
    0 / 1089 (0.00%)
    1 / 2606 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Retinal tear
         subjects affected / exposed [24]
    1 / 511 (0.20%)
    0 / 2965 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed [25]
    1 / 1089 (0.09%)
    0 / 2606 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    0 / 1089 (0.00%)
    2 / 2965 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal failure chronic
         subjects affected / exposed [26]
    1 / 1089 (0.09%)
    0 / 2606 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Chondrocalcinosis
         subjects affected / exposed [27]
    0 / 511 (0.00%)
    1 / 2965 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foot deformity
         subjects affected / exposed [28]
    0 / 1089 (0.00%)
    1 / 2606 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lumbar spinal stenosis
         subjects affected / exposed [29]
    1 / 1089 (0.09%)
    0 / 2606 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed [30]
    0 / 1089 (0.00%)
    2 / 2606 (0.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rheumatoid arthritis
         subjects affected / exposed [31]
    0 / 511 (0.00%)
    1 / 2965 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rotator cuff syndrome
         subjects affected / exposed [32]
    1 / 511 (0.20%)
    0 / 2965 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Clostridium colitis
         subjects affected / exposed [33]
    0 / 511 (0.00%)
    1 / 2965 (0.03%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed [34]
    0 / 1089 (0.00%)
    1 / 2606 (0.04%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperkalaemia
         subjects affected / exposed [35]
    1 / 1089 (0.09%)
    0 / 2606 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The total number (N) represents vaccinated subjects with at least one safety record for the unsolicited adverse events is available.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The total number (N) represents vaccinated subjects with at least one safety record for the unsolicited adverse events is available.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The total number (N) represents vaccinated subjects with at least one safety record for the unsolicited adverse events is available.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The total number (N) represents vaccinated subjects with at least one safety record for the unsolicited adverse events is available.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The total number (N) represents vaccinated subjects with at least one safety record for the unsolicited adverse events is available.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The total number (N) represents vaccinated subjects with at least one safety record for the unsolicited adverse events is available.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The total number (N) represents vaccinated subjects with at least one safety record for the unsolicited adverse events is available.
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The total number (N) represents vaccinated subjects with at least one safety record for the unsolicited adverse events is available.
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The total number (N) represents vaccinated subjects with at least one safety record for the unsolicited adverse events is available.
    [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The total number (N) represents vaccinated subjects with at least one safety record for the unsolicited adverse events is available.
    [11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The total number (N) represents vaccinated subjects with at least one safety record for the unsolicited adverse events is available.
    [12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The total number (N) represents vaccinated subjects with at least one safety record for the unsolicited adverse events is available.
    [13] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The total number (N) represents vaccinated subjects with at least one safety record for the unsolicited adverse events is available.
    [14] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The total number (N) represents vaccinated subjects with at least one safety record for the unsolicited adverse events is available.
    [15] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The total number (N) represents vaccinated subjects with at least one safety record for the unsolicited adverse events is available.
    [16] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The total number (N) represents vaccinated subjects with at least one safety record for the unsolicited adverse events is available.
    [17] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The total number (N) represents vaccinated subjects with at least one safety record for the unsolicited adverse events is available.
    [18] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The total number (N) represents vaccinated subjects with at least one safety record for the unsolicited adverse events is available.
    [19] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The total number (N) represents vaccinated subjects with at least one safety record for the unsolicited adverse events is available.
    [20] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The total number (N) represents vaccinated subjects with at least one safety record for the unsolicited adverse events is available.
    [21] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The total number (N) represents vaccinated subjects with at least one safety record for the unsolicited adverse events is available.
    [22] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The total number (N) represents vaccinated subjects with at least one safety record for the unsolicited adverse events is available.
    [23] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The total number (N) represents vaccinated subjects with at least one safety record for the unsolicited adverse events is available.
    [24] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The total number (N) represents vaccinated subjects with at least one safety record for the unsolicited adverse events is available.
    [25] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The total number (N) represents vaccinated subjects with at least one safety record for the unsolicited adverse events is available.
    [26] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The total number (N) represents vaccinated subjects with at least one safety record for the unsolicited adverse events is available.
    [27] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The total number (N) represents vaccinated subjects with at least one safety record for the unsolicited adverse events is available.
    [28] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The total number (N) represents vaccinated subjects with at least one safety record for the unsolicited adverse events is available.
    [29] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The total number (N) represents vaccinated subjects with at least one safety record for the unsolicited adverse events is available.
    [30] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The total number (N) represents vaccinated subjects with at least one safety record for the unsolicited adverse events is available.
    [31] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The total number (N) represents vaccinated subjects with at least one safety record for the unsolicited adverse events is available.
    [32] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The total number (N) represents vaccinated subjects with at least one safety record for the unsolicited adverse events is available.
    [33] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The total number (N) represents vaccinated subjects with at least one safety record for the unsolicited adverse events is available.
    [34] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The total number (N) represents vaccinated subjects with at least one safety record for the unsolicited adverse events is available.
    [35] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: The total number (N) represents vaccinated subjects with at least one safety record for the unsolicited adverse events is available.
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 IM 15μg ID 15μg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    186 / 1089 (17.08%)
    1859 / 2965 (62.70%)
    Nervous system disorders
    Headache (Post-first vaccination)
    alternative assessment type: Systematic
         subjects affected / exposed [36]
    138 / 1083 (12.74%)
    339 / 2601 (13.03%)
         occurrences all number
    138
    339
    General disorders and administration site conditions
    Injection site pain (Post-second vaccination)
    alternative assessment type: Systematic
         subjects affected / exposed [37]
    96 / 508 (18.90%)
    685 / 2960 (23.14%)
         occurrences all number
    96
    685
    Injection site erythema (Post-first vaccination)
    alternative assessment type: Systematic
         subjects affected / exposed [38]
    163 / 1082 (15.06%)
    1845 / 2601 (70.93%)
         occurrences all number
    163
    1845
    Injection site swelling (Post-first vaccination)
    alternative assessment type: Systematic
         subjects affected / exposed [39]
    91 / 1082 (8.41%)
    931 / 2601 (35.79%)
         occurrences all number
    91
    931
    Injection site induration (Post-first vaccination)
    alternative assessment type: Systematic
         subjects affected / exposed [40]
    122 / 1082 (11.28%)
    979 / 2601 (37.64%)
         occurrences all number
    122
    979
    Fever (Post-third vaccination)
    alternative assessment type: Systematic
         subjects affected / exposed [41]
    8 / 228 (3.51%)
    151 / 2916 (5.18%)
         occurrences all number
    8
    151
    Malaise (Post-first vaccination)
    alternative assessment type: Systematic
         subjects affected / exposed [42]
    85 / 1083 (7.85%)
    220 / 2601 (8.46%)
         occurrences all number
    85
    220
    Shivering (Post-second vaccination)
    alternative assessment type: Systematic
         subjects affected / exposed [43]
    28 / 508 (5.51%)
    159 / 2960 (5.37%)
         occurrences all number
    28
    159
    Skin and subcutaneous tissue disorders
    Injection site pruritus (Post-first vaccination)
    alternative assessment type: Systematic
         subjects affected / exposed [44]
    66 / 1083 (6.09%)
    766 / 2601 (29.45%)
         occurrences all number
    66
    766
    Musculoskeletal and connective tissue disorders
    Myalgia (Post-second vaccination)
    alternative assessment type: Systematic
         subjects affected / exposed [45]
    54 / 508 (10.63%)
    339 / 2960 (11.45%)
         occurrences all number
    54
    339
    Notes
    [36] - 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 that were 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.
    [37] - 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 that were 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.
    [38] - 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 that were 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.
    [39] - 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 that were 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.
    [40] - 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 that were 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.
    [41] - 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 that were 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.
    [42] - 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 that were 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.
    [43] - 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 that were 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.
    [44] - 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 that were 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.
    [45] - 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 that were 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.

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Sep 2006
    Change of the Principal Investigator for the center of Antwerp in Belgium (Dr. Buggenhout replacing Dr. Vets), addition of batches numbers of investigational and control product, and change of the Clinical Trial Manager (Hélène Berninger replacing Séverine Alric).
    09 Nov 2006
    An information note to the Belgian subjects regarding the new Principal Investigator Dr. de Decker was created.
    22 May 2007
    Specified the formulation of the 2007-2008 NH influenza vaccine recommended by the World Health Organization (WHO) and the Committee for Human Medicinal Products (CHMP), documented a change of Principal Investigator in Genoa, Italy (Professor Icardi replaced Professor Crovari), notified few minor updates on processes regarding the sample preparation, Vaccination Comfort Questionnaire (VCQ) form, SAE reporting and the data management system with the implementation of electronic Case Report Form (Case Book).
    22 May 2008
    Specified the formulation of the investigational and comparator vaccines to be administered for the third vaccination (2008-2009 NH strains recommended by the WHO and the CHMP BWP ad hoc Influenza working group), documented that two centers from Belgium stopped the study, added the reporting of adverse events of special interest (convulsions, encephalomyelitis, Guillain Barré syndrome, neuritis, severe allergic reactions, syncope, thrombocytopenia, and vasculitis) in addition to SAEs from visit 08 up to 6-month after the third vaccination, added the evaluation of the safety profile of suspected atopic subjects following the three vaccinations as an observational objective, documented changes in the second analysis, which was performed in two steps instead of one (1st step analysis covered all data from Visit 03 to Visit 06, including SAEs recorded until the 12th of March 2008, and excluding the serological results of Visit 05 and Visit 06 and 2nd step analysis updated the 1st step analysis when the serological results of Visit 05 and Visit 06 were available), updated the reference of the current Investigator Brochure, the last question of the VCQ form, the description of the randomization process at Visit 05 and at Visit 07 and updated the batch number of vaccines used for Year 1 vaccination, and specified that Electronic Data Capture solutions were provided by the Sponsor to the investigators.

    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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