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    Clinical Trial Results:
    Immunogenicity of the Inactivated, Split-Virion Influenza Vaccine Administered by the Intradermal Route in Comparison with Intramuscular Vaccination with Vaxigrip® in Adults.

    Summary
    EudraCT number
    2005-002401-23
    Trial protocol
    DE   BE  
    Global end of trial date
    02 Jul 2008

    Results information
    Results version number
    v1(current)
    This version publication date
    05 Feb 2016
    First version publication date
    27 Sep 2014
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GID15
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00258934
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur SA
    Sponsor organisation address
    1541, Avenue Marcel Mérieux, Marcy L’Etoile, France, 69280
    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
    21 Jul 2008
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Jul 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that the vaccine administered by the intradermal (ID) route with the new Becton Dickinson (BD) ID system (pre-filled ID system allowing a better ergonomic use) is at least as immunogenic as the administration of the vaccine by the intramuscular (IM) route 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 were also available on site in case of any immediate allergic reactions.
    Background therapy
    Not applicable.
    Evidence for comparator
    Same vaccine with a different route of administration. An earlier study in 2002, GID01 conducted in 300 Lithuanian adult subjects assessed three dosages (3 µg, 6 µg, and 9 µg of each HA per strain) administered with an intradermal (ID) system, one dosage (3 µg of each HA per strain) administered with a classic ID syringe, and, as a reference, Vaxigrip® IM (containing 15 µg of each HA per strain), showed that the trivalent inactivated split-virion influenza vaccine induced a similar immune response as measured by geometric mean of titers (GMTs), when administered by the IM route or the ID route.
    Actual start date of recruitment
    19 Sep 2005
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Efficacy, Safety
    Long term follow-up duration
    3 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 750
    Country: Number of subjects enrolled
    Germany: 150
    Country: Number of subjects enrolled
    Switzerland: 78
    Worldwide total number of subjects
    978
    EEA total number of subjects
    900
    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)
    978
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Study subjects were enrolled and vaccinated from 19 September 2005 to 21 November 2005, at 4 clinical centers in Belgium, Germany and Switzerland. They got a second vaccination (Year 1) from 20 September 2006 to 31 October 2006, and a third vaccination (Year 2) from 24 September 2007 to 07 November 2007.

    Pre-assignment
    Screening details
    A total of 978 subjects who met all the inclusion, but none of the exclusion criteria were enrolled and vaccinated in the study.

    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Intradermal Vaccination Group
    Arm description
    Subjects received 9 µg dose influenza vaccine by the intradermal route on Day 0 (first vaccination)
    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 (9 µg) single annual dose, intradermal into the upper arm (deltoid area)

    Arm title
    Intramuscular Vaccine Group
    Arm description
    Subjects received 15 µg dose influenza vaccine by the intramuscular route on Day 0 (first vaccination)
    Arm type
    Active comparator

    Investigational medicinal product name
    Intradermal Influenza Vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5 mL (15 µg) single annual dose, intramuscular into the upper arm (deltoid area)

    Number of subjects in period 1
    Intradermal Vaccination Group Intramuscular Vaccine Group
    Started
    588
    390
    Completed
    588
    390

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Intradermal Vaccination Group
    Reporting group description
    Subjects received 9 µg dose influenza vaccine by the intradermal route on Day 0 (first vaccination)

    Reporting group title
    Intramuscular Vaccine Group
    Reporting group description
    Subjects received 15 µg dose influenza vaccine by the intramuscular route on Day 0 (first vaccination)

    Reporting group values
    Intradermal Vaccination Group Intramuscular Vaccine Group Total
    Number of subjects
    588 390 978
    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)
    588 390 978
        From 65-84 years
    0 0 0
        85 years and over
    0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    40.1 ± 10.9 40.2 ± 11.2 -
    Gender categorical
    Units: Subjects
        Female
    367 245 612
        Male
    221 145 366
    Previous influenza vaccination
    Units: Subjects
        Yes
    229 147 376
        No
    344 231 575
        Unknown
    15 12 27

    End points

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    End points reporting groups
    Reporting group title
    Intradermal Vaccination Group
    Reporting group description
    Subjects received 9 µg dose influenza vaccine by the intradermal route on Day 0 (first vaccination)

    Reporting group title
    Intramuscular Vaccine Group
    Reporting group description
    Subjects received 15 µg dose influenza vaccine by the intramuscular route on Day 0 (first vaccination)

    Primary: Geometric Mean Titers of Antibodies to Influenza Antigens Before and After either Intradermal or Intramuscular Influenza vaccination

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    End point title
    Geometric Mean Titers of Antibodies to Influenza Antigens Before and After either Intradermal or Intramuscular Influenza vaccination
    End point description
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and 21 days Post-vaccination
    End point values
    Intradermal Vaccination Group Intramuscular Vaccine Group
    Number of subjects analysed
    381
    379
    Units: Titers
    geometric mean (confidence interval 95%)
        A/ H1N1 (Pre-vaccination)
    15.3 (13.3 to 17.7)
    14.6 (12.7 to 16.7)
        A/ H3N2 (Pre-vaccination)
    29.4 (25.6 to 33.7)
    27.1 (23.9 to 30.7)
        B (Pre-vaccination)
    12 (10.8 to 13.3)
    11.3 (10.3 to 12.5)
        A/ H1N1 (Post-vaccination)
    249 (216 to 287)
    199 (170 to 232)
        A/ H3N2 (Post-vaccination)
    828 (738 to 928)
    571 (502 to 649)
        B (Post-vaccination)
    144 (129 to 161)
    124 (110 to 139)
    Statistical analysis title
    Non-inferiority test of ID Group for A/H1N1 Strain
    Statistical analysis description
    For each strain, the primary parameter was the difference of the log10 transformation of post-vaccination geometric mean of titer between the compared vaccine groups. For each strain, the hypotheses tested were as follows: H0: log10(GMTID)-log10(GMTIM) ≤ -0.176 which is equivalent to GMTIM / GMTID ≥ 1.5 H1: log10(GMTID)-log10(GMTIM) > -0.176 which is equivalent to GMTIM / GMTID < 1.5 The ID group was considered as non-inferior to the IM group if the hypothesis H0 was rejected for each strain
    Comparison groups
    Intradermal Vaccination Group v Intramuscular Vaccine Group
    Number of subjects included in analysis
    760
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [1]
    Method
    2-Sided Confidence Interval
    Parameter type
    Median difference (final values)
    Point estimate
    0.098
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.006
         upper limit
    0.189
    Notes
    [1] - The ID group was considered as non-inferior to the IM group if the hypothesis H0 was rejected for each strain.
    Statistical analysis title
    Non-inferiority test of ID Group for A/H3N2 Strain
    Statistical analysis description
    For each strain, the primary parameter was the difference of the log10 transformation of post-vaccination geometric mean of titer between the compared vaccine groups. For each strain, the hypotheses tested were as follows: H0: log10(GMTID)-log10(GMTIM) ≤ -0.176 which is equivalent to GMTIM / GMTID ≥ 1.5 H1: log10(GMTID)-log10(GMTIM) > -0.176 which is equivalent to GMTIM / GMTID < 1.5 The ID group was considered as non-inferior to the IM group if the hypothesis H0 was rejected for each strain
    Comparison groups
    Intradermal Vaccination Group v Intramuscular Vaccine Group
    Number of subjects included in analysis
    760
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [2]
    Method
    2-Sided Confidence Interval
    Parameter type
    Median difference (final values)
    Point estimate
    0.162
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.087
         upper limit
    0.236
    Notes
    [2] - The ID group was considered as non-inferior to the IM group if the hypothesis H0 was rejected for each strain.
    Statistical analysis title
    Non-inferiority test of ID Group for B Strain
    Statistical analysis description
    For each strain, the primary parameter was the difference of the log10 transformation of post-vaccination geometric mean of titer between the compared vaccine groups. For each strain, the hypotheses tested were as follows: H0: log10(GMTID)-log10(GMTIM) ≤ -0.176 which is equivalent to GMTIM / GMTID ≥ 1.5 H1: log10(GMTID)-log10(GMTIM) > -0.176 which is equivalent to GMTIM / GMTID < 1.5 The ID group was considered as non-inferior to the IM group if the hypothesis H0 was rejected for each strain
    Comparison groups
    Intradermal Vaccination Group v Intramuscular Vaccine Group
    Number of subjects included in analysis
    760
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [3]
    Method
    2-Sided Confidence Interval
    Parameter type
    Median difference (final values)
    Point estimate
    0.067
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -0.003
         upper limit
    0.136
    Notes
    [3] - The ID group was considered as non-inferior to the IM group if the hypothesis H0 was rejected for each strain.

    Secondary: Percentage of Subjects with Seroprotection Against Influenza Antigens Before and After First Vaccination with either Intradermal or Intramucular Influenza Vaccine

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    End point title
    Percentage of Subjects with Seroprotection Against Influenza Antigens Before and After First Vaccination with either Intradermal or Intramucular Influenza Vaccine
    End point description
    Influenza virus antibodies were measured by the hemagglutination inhibition (HI) technique. Seroprotection was defined as an antibody titer of ≥40 1/dilution.
    End point type
    Secondary
    End point timeframe
    Day 0 (pre-vaccination) snd 21 Days Post-vaccination (First vaccination)
    End point values
    Intradermal Vaccination Group Intramuscular Vaccine Group
    Number of subjects analysed
    383
    385
    Units: Percentage of Subjects
    number (not applicable)
        A/H1N1 (Pre-vaccination)
    27.7
    26.2
        A/H3N2 (Pre-vaccination)
    43.9
    40.9
        B (Pre-vaccination)
    16.8
    16.6
        A/H1N1 (Post-vaccination)
    92.4
    88.8
        A/H3N2 (Post-vaccination)
    99.7
    98.7
        B (Post-vaccination)
    90.6
    85.5
    No statistical analyses for this end point

    Secondary: Percentage of Subjects with Seroconversion or Significant Increase in Influenza Antibodies Post-vaccination with either an Intradermal or Intramucular Influenza Vaccine

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    End point title
    Percentage of Subjects with Seroconversion or Significant Increase in Influenza Antibodies Post-vaccination with either an Intradermal or Intramucular Influenza Vaccine
    End point description
    Influenza antibodies were measured using the hemagglutination inhibition (HI) technique. Seroconversion was defined as a pre-vaccination titer <10 (1/dil): post-injection titer ≥40 (1/dil) on Day 21; Significant increase was defined as a pre-vaccination titer ≥10 (1/dil): ≥4-fold increase from pre- to post-injection titer on Day 21.
    End point type
    Secondary
    End point timeframe
    21 Days post-vaccination
    End point values
    Intradermal Vaccination Group Intramuscular Vaccine Group
    Number of subjects analysed
    383
    385
    Units: Percentage of Subjects
    number (not applicable)
        A/H1N1 (A/New Caledonia/20/99)
    74.3
    70.4
        A/H3N2 (A/Wellington/1/2004)
    85.1
    79.2
        B (B/Jiangsu/361/2002)
    76.4
    73.5
    No statistical analyses for this end point

    Secondary: Number of Subjects Experiencing at Least one Reaction Listed in the EMEA Note for Guidance Within 3 days After First Vaccination with Either an Intradermal or Intramuscular Influenza Vaccine

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    End point title
    Number of Subjects Experiencing at Least one Reaction Listed in the EMEA Note for Guidance Within 3 days After First Vaccination with Either an Intradermal or Intramuscular Influenza Vaccine
    End point description
    End point type
    Secondary
    End point timeframe
    Within 3 Days post-vaccination (First vaccination)
    End point values
    Intradermal Vaccination Group Intramuscular Vaccine Group
    Number of subjects analysed
    588
    390
    Units: Subjects
        Injection site induration >5 cm for > 3 days
    1
    0
        Injection site ecchymosis (bruising)
    9
    9
        Fever (rectal equivalent temperature > 30.0 C) for
    9
    3
        Malaise
    68
    56
        Shivering (Rigors)
    35
    29
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting Solicited Reactions Within 7 Days After First Vaccination with Either an Intradermal or Intramuscular Influenza Vaccine

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    End point title
    Number of Subjects Reporting Solicited Reactions Within 7 Days After First Vaccination with Either an Intradermal or Intramuscular Influenza Vaccine
    End point description
    End point type
    Secondary
    End point timeframe
    Day 0 to Day 7 Post First Vaccination
    End point values
    Intradermal Vaccination Group Intramuscular Vaccine Group
    Number of subjects analysed
    588
    390
    Units: Subjects
        Injection site Ecchymosis
    18
    10
        Injection site Erythema
    505
    44
        Injection site Induration
    367
    49
        Injection site Pain
    220
    149
        Injection site Pruritus
    210
    17
        Injection site Swelling
    377
    31
        Fever
    20
    14
        Headache
    192
    116
        Malaise
    84
    66
        Myalgia
    114
    113
        Shivering
    38
    33
    No statistical analyses for this end point

    Secondary: Number of Subjects Experiencing at Least one Reaction Listed in the EMEA Note for Guidance Within 3 days After Second Vaccination with Either an Intradermal or Intramuscular Influenza Vaccine

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    End point title
    Number of Subjects Experiencing at Least one Reaction Listed in the EMEA Note for Guidance Within 3 days After Second Vaccination with Either an Intradermal or Intramuscular Influenza Vaccine
    End point description
    End point type
    Secondary
    End point timeframe
    Within 3 Days post-second injection
    End point values
    Intradermal Vaccination Group Intramuscular Vaccine Group
    Number of subjects analysed
    529
    349
    Units: Subjects
        Injection site Induration >5 cm for >3 days
    2
    0
        Injetion site ecchymosis (Bruising)
    15
    7
        Pyrexia (rectal equivalent temp >38.0 C) for 24 hr
    6
    4
        Malaise
    55
    36
        Shivering (Rigors)
    28
    20
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting Solicited Reactions Within 7 Days After Second Vaccination with Either an Intradermal or Intramuscular Influenza Vaccine

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    End point title
    Number of Subjects Reporting Solicited Reactions Within 7 Days After Second Vaccination with Either an Intradermal or Intramuscular Influenza Vaccine
    End point description
    End point type
    Secondary
    End point timeframe
    Day 0 up to Day 7 post-second vaccination
    End point values
    Intradermal Vaccination Group Intramuscular Vaccine Group
    Number of subjects analysed
    529
    349
    Units: Subjects
        Injection site Ecchymosis
    19
    7
        Injection site Erythema
    461
    70
        Injection site Induration
    407
    78
        Injection site Pain
    214
    149
        Injection site Pruritus
    228
    37
        Injection site Swelling
    330
    45
        Fever
    15
    12
        Headache
    156
    88
        Malaise
    70
    49
        Myalgia
    97
    100
        Shivering
    32
    24
    No statistical analyses for this end point

    Secondary: Number of Subjects Experiencing at Least One Reaction Listed in the EMEA Note for Guidance Within 3 days After Third Vaccination with Either an Intradermal or Intramuscular Influenza Vaccine

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    End point title
    Number of Subjects Experiencing at Least One Reaction Listed in the EMEA Note for Guidance Within 3 days After Third Vaccination with Either an Intradermal or Intramuscular Influenza Vaccine
    End point description
    End point type
    Secondary
    End point timeframe
    Within 3 Days After Third Vaccination
    End point values
    Intradermal Vaccination Group Intramuscular Vaccine Group
    Number of subjects analysed
    494
    324
    Units: Subjects
        Injection site Induration >5 cm for >3 days
    2
    1
        Injection site Ecchymosis (Bruising)
    11
    11
        Pyrexia (rectal equivalent temp >38.0 C) for ≥24h
    8
    3
        Malaise
    54
    33
        Shivering (Rigors)
    19
    25
    No statistical analyses for this end point

    Other pre-specified: Antibody Persistence to Influenza Antigens Before and 21 Days, 3, 6 and 12 Months Post-vaccination with Either Intradermal or an Intramuscular Influenza Vaccine

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    End point title
    Antibody Persistence to Influenza Antigens Before and 21 Days, 3, 6 and 12 Months Post-vaccination with Either Intradermal or an Intramuscular Influenza Vaccine
    End point description
    Influenza antibodies were measured using the hemagglutination inhibition (HI) technique. Antibody persistence was defined as seroprotection, antibody titer ≥40 (1/dilution) at each defined timepoints.
    End point type
    Other pre-specified
    End point timeframe
    Day 0 (pre-vaccination) and 21 Days, 3, 6 and 12 months post-vaccination
    End point values
    Intradermal Vaccination Group Intramuscular Vaccine Group
    Number of subjects analysed
    383
    385
    Units: Percentage of Subjects
    number (not applicable)
        A/H1N1 (Pre-vaccination)
    27.7
    26.2
        A/H3N2 (Pre-vaccination)
    43.9
    40.8
        B (Pre-vaccination)
    16.7
    16.6
        A/H1N1 (Day 21 Post-vaccination)
    92.4
    88.8
        A/H3N2 (Day 21 Post-vaccination)
    99.7
    98.7
        B (Day 21 Post-vaccination)
    90.6
    85.5
        A/H1N1 (3 Months Post-vaccination)
    86.7
    81.3
        A/H3N2 (3 Months Post-vaccination)
    98.9
    97.1
        B (3 Months Post-vaccination)
    77.5
    72.6
        A/H1N1 (6 Months Post-vaccination)
    82
    75.9
        A/H3N2 (6 Months Post-vaccination)
    97.8
    95.8
        B (6 Months Post-vaccination)
    61.4
    65.7
        A/H1N1 (12 Months Post-vaccination)
    68.2
    67.7
        A/H3N2 (12 Months Post-vaccination)
    96.2
    89.1
        B (12 Months Post-vaccination)
    49.9
    53.7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events data were collected from Day 0 after Dose 1 through up to 6 months after the last dose
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    7.0
    Reporting groups
    Reporting group title
    Intradermal Vaccination Group
    Reporting group description
    Subjects received 9 µg influenza vaccine by the intradermal route on Day 0 (first vaccination)

    Reporting group title
    Intramuscular Vaccine Group
    Reporting group description
    Subjects received 0.5 mL (15 µg) dose by the intramuscular route

    Serious adverse events
    Intradermal Vaccination Group Intramuscular Vaccine Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 588 (0.00%)
    0 / 390 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Intradermal Vaccination Group Intramuscular Vaccine Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    35 / 588 (5.95%)
    17 / 390 (4.36%)
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    35 / 588 (5.95%)
    17 / 390 (4.36%)
         occurrences all number
    35
    17

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Aug 2005
    The use of paper CRF instead of electronic CRF; Ealuation of immunogenicity in a subset of subjects following the second and third vaccinations; Definition of Serum storage and shipping temperature.
    16 Mar 2006
    The replacement of a Principal Investigator in Germany, was submitted to the German IEC only.
    23 May 2006
    Information on the vaccine formulation to be administered for the second vaccination (2006-2007 Northern Hemisphere) and planned the assessment of the comfort vaccination using a Verbal Rating Scale (VRS) and a Patient-Reported Outcome questionnaire: the Vaccination Comfort Questionnaire (VCQ).
    19 Jun 2006
    Before the second vaccination a modification of the immunogenicity analysis.
    13 Sep 2006
    A replacement of a Principal Investigator in Belgium was submitted to the Belgium IEC only.
    10 Nov 2006
    A replacement of a Principal Investigator in Belgium was submitted to the Belgium IEC only.
    24 May 2007
    Information on the vaccine formulation to be administered for the third vaccination (2007-2008 Northern Hemisphere) was provided along with notice of the change of Center Name from "MDS Pharma Germany GmbH" to "Momentum Pharma Service GmbH” and the an update to the process of documenting local reactions at the injection site; the sample preparation process, and the VCQ form and the SAEs reporting process.

    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.
    Not applicable.
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