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    Clinical Trial Results:
    Immunogenicity and Safety of the Trivalent Influenza Vaccine (Split-Virion, Inactivated), Northern Hemisphere 2013-2014 Formulation (Intradermal Route)

    Summary
    EudraCT number
    2012-005243-25
    Trial protocol
    FR  
    Global end of trial date
    30 Jul 2013

    Results information
    Results version number
    v1(current)
    This version publication date
    10 Feb 2016
    First version publication date
    03 Dec 2014
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GID37
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    U1111-1127-7490
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur SA
    Sponsor organisation address
    1541, Avenue Marcel Mérieux, Marcy L’Etoile, France, 69280
    Public contact
    Medical Franchise Leader, Sanofi Pasteur SA, +33 (0)4 37 37 70 82 , eric.desauziers@sanofipasteur.com
    Scientific contact
    Medical Franchise Leader, Sanofi Pasteur SA, +33 (0)4 37 37 70 82 , eric.desauziers@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
    14 Aug 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jul 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    -To evaluate the compliance, in terms of immunogenicity, of the ID influenza vaccine NH 2013-2014 formulation with the requirements of the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96 in both age groups -To describe the safety of the ID influenza vaccine NH 2013-2014 formulation in both age groups
    Protection of trial subjects
    Only subjects that met all the study inclusion and none of the exclusion criteria were 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
    The new formulation of the trivalent ID influenza vaccine for the 2013-2014 season in the Northern Hemisphere was evaluated in compliance with the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance (NfG) on harmonization of requirements for influenza vaccines CPMP/BWP/214/96.
    Evidence for comparator
    Not applicable
    Actual start date of recruitment
    03 Jul 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 130
    Worldwide total number of subjects
    130
    EEA total number of subjects
    130
    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)
    96
    From 65 to 84 years
    34
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Study subjects were enrolled from 03 July 2013 to 10 July 2013 in 2 clinic centers in France.

    Pre-assignment
    Screening details
    A total of 130 subjects who met all inclusion criteria and none of the exclusion criteria were enrolled and vaccinated.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    18 to 59 years (9 µg)
    Arm description
    Subjects aged 18 to 59 years who were vaccinated with one dose of the intradermal (ID) influenza vaccine 9 µg, Northern Hemisphere (NH) 2013-2014 formulation.
    Arm type
    Experimental

    Investigational medicinal product name
    IDflu 9μg
    Investigational medicinal product code
    415
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    0.1 mL, intradermal into the deltoid muscle area, one dose on Day 0

    Arm title
    60 years or older (15 µg)
    Arm description
    Subjects aged 60 years or older who were vaccinated with one dose of the intradermal (ID) influenza vaccine 15 µg, NH 2013-2014 formulation.
    Arm type
    Experimental

    Investigational medicinal product name
    IDflu 15μg
    Investigational medicinal product code
    416
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intradermal use
    Dosage and administration details
    0.1 mL, intradermal into the deltoid muscle area, one dose on Day 0

    Number of subjects in period 1
    18 to 59 years (9 µg) 60 years or older (15 µg)
    Started
    65
    65
    Completed
    65
    65

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    18 to 59 years (9 µg)
    Reporting group description
    Subjects aged 18 to 59 years who were vaccinated with one dose of the intradermal (ID) influenza vaccine 9 µg, Northern Hemisphere (NH) 2013-2014 formulation.

    Reporting group title
    60 years or older (15 µg)
    Reporting group description
    Subjects aged 60 years or older who were vaccinated with one dose of the intradermal (ID) influenza vaccine 15 µg, NH 2013-2014 formulation.

    Reporting group values
    18 to 59 years (9 µg) 60 years or older (15 µg) Total
    Number of subjects
    65 65 130
    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)
    65 31 96
        From 65-84 years
    0 34 34
        85 years and over
    0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    41.7 ± 12.6 67.1 ± 5.5 -
    Gender categorical
    Units: Subjects
        Female
    35 37 72
        Male
    30 28 58
    Seasonal flu vaccination NH 2012-2013
    Units: Subjects
        Yes
    11 23 34
        No
    54 42 96
        Unknown
    0 0 0
    History of influenza diagnosis in the previous year
    Units: Subjects
        Yes
    1 0 1
        No
    64 65 129
        Unknown
    0 0 0

    End points

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    End points reporting groups
    Reporting group title
    18 to 59 years (9 µg)
    Reporting group description
    Subjects aged 18 to 59 years who were vaccinated with one dose of the intradermal (ID) influenza vaccine 9 µg, Northern Hemisphere (NH) 2013-2014 formulation.

    Reporting group title
    60 years or older (15 µg)
    Reporting group description
    Subjects aged 60 years or older who were vaccinated with one dose of the intradermal (ID) influenza vaccine 15 µg, NH 2013-2014 formulation.

    Primary: Geometric Mean Titers (GMTs) of influenza Vaccine Antibodies Before and After Vaccination with Inactivated, Split-Virion Influenza Vaccine Administered by Intradermal Route

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    End point title
    Geometric Mean Titers (GMTs) of influenza Vaccine Antibodies Before and After Vaccination with Inactivated, Split-Virion Influenza Vaccine Administered by Intradermal Route [1]
    End point description
    Antibodies against influenza vaccine were evaluated using the hemagglutination inhibition technique.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 post-vaccination
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    18 to 59 years (9 µg) 60 years or older (15 µg)
    Number of subjects analysed
    65
    65
    Units: Titers
    geometric mean (confidence interval 95%)
        A/California/07/2009 (H1N1; Day 0)
    52.2 (35.2 to 77.6)
    21.2 (14.7 to 30.7)
        A/Texas/50/2012 (H3N2; Day 0)
    48.2 (32.6 to 71.4)
    47.4 (31.6 to 71.3)
        B/Massachusetts/02/2012 (Day 0)
    164 (118 to 230)
    85.3 (61 to 119)
        A/California/07/2009 (H1N1; Day 21)
    467 (356 to 613)
    240 (164 to 351)
        A/Texas/50/2012 (H3N2; Day 21)
    708 (511 to 981)
    585 (406 to 843)
        B/Massachusetts/02/2012 (Day 21)
    1233 (959 to 1586)
    572 (446 to 733)
    No statistical analyses for this end point

    Primary: Percentage of Subjects with Seroprotection Against Influenza Vaccine Antigens Before and After Vaccination with Inactivated, Split-Virion Influenza Vaccine Administered by Intradermal Route

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    End point title
    Percentage of Subjects with Seroprotection Against Influenza Vaccine Antigens Before and After Vaccination with Inactivated, Split-Virion Influenza Vaccine Administered by Intradermal Route [2]
    End point description
    Antibodies against influenza vaccine were evaluated using the hemagglutination inhibition technique. Seroprotection was defined as titer ≥40 (1/dilution [1/dil]) on Day 0 and Day 21.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 post-vaccination
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    18 to 59 years (9 µg) 60 years or older (15 µg)
    Number of subjects analysed
    65
    65
    Units: Percentage of subjects
    number (not applicable)
        A/California/07/2009 (H1N1; Day 0)
    64.6
    35.4
        A/Texas/50/2012 (H3N2; Day 0)
    56.9
    58.5
        B/Massachusetts/02/2012 (Day 0)
    87.7
    78.5
        A/California/07/2009 (H1N1; Day 21)
    95.4
    87.7
        A/Texas/50/2012 (H3N2; Day 21)
    98.5
    98.5
        B/Massachusetts/02/2012 (Day 21)
    100
    100
    No statistical analyses for this end point

    Primary: Summary of Geometric Mean Titer Ratios (GMTRs) of Influenza Vaccine Antibodies After Vaccination with Inactivated, Split-Virion Influenza Vaccine Administered by Intradermal Route

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    End point title
    Summary of Geometric Mean Titer Ratios (GMTRs) of Influenza Vaccine Antibodies After Vaccination with Inactivated, Split-Virion Influenza Vaccine Administered by Intradermal Route [3]
    End point description
    Antibodies against influenza vaccine were evaluated using the hemagglutination inhibition technique. Geometric mean titer ratio is the geometric mean of the individual post-vaccination/pre-vaccination titer of antibodies to the influenza vaccine.
    End point type
    Primary
    End point timeframe
    Day 0 (pre-vaccination) and Day 21 post-vaccination
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    18 to 59 years (9 µg) 60 years or older (15 µg)
    Number of subjects analysed
    65
    65
    Units: Titer ratios
    geometric mean (confidence interval 95%)
        A/California/07/2009 (H1N1)
    8.95 (6.02 to 13.3)
    11.3 (7.2 to 17.8)
        A/Texas/50/2012 (H3N2)
    14.7 (9.6 to 22.5)
    12.3 (7.82 to 19.4)
        B/Massachusetts/02/2012
    7.5 (5.38 to 10.5)
    6.71 (4.68 to 9.62)
    No statistical analyses for this end point

    Primary: Percentage of Subjects Achieving Seroconversion or Significant Increase in Influenza Vaccine Antibodies Following Vaccination with Inactivated, Split-Virion Influenza Vaccine Administered by Intradermal Route

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    End point title
    Percentage of Subjects Achieving Seroconversion or Significant Increase in Influenza Vaccine Antibodies Following Vaccination with Inactivated, Split-Virion Influenza Vaccine Administered by Intradermal Route [4]
    End point description
    Seroconversion was defined as percentage of subjects with a pre-vaccination titer < 10 (1/dil) to a post-vaccination titer >= 40 (1/dil) ; Significant increase was defined as the precentage of subjects with a pre-vaccination titer >= 10 (1/dil) and >= 4-fold increase of the titer.
    End point type
    Primary
    End point timeframe
    Day 21 post-vaccination
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive analyses were performed based on the study groups and the study vaccine administered for this outcome.
    End point values
    18 to 59 years (9 µg) 60 years or older (15 µg)
    Number of subjects analysed
    65
    65
    Units: Percentage
    number (not applicable)
        A/California/07/2009 (H1N1)
    61.5
    61.5
        A/Texas/50/2012 (H3N2)
    76.9
    72.3
        B/Massachusetts/02/2012
    61.5
    63.1
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Reporting Solicited Injection Site or Systemic Reactions Following Vaccination with Inactivated, Split-Virion Influenza Vaccine Administered by Intradermal Route

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    End point title
    Percentage of Subjects Reporting Solicited Injection Site or Systemic Reactions Following Vaccination with Inactivated, Split-Virion Influenza Vaccine Administered by Intradermal Route
    End point description
    Solicited Injection Site Reactions: Injection site Pain, Injection site Erythema, Injection site Swelling, Injection site Induration, Injection site Ecchymosis, and Injection site Pruritus. Solicited Systemic Reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3 Solicited Injection Site Reactions: Injection site Pain and Pruritus, Significant, prevents daily activity; Injection site Erythema, Swelling, Induration, and Ecchymosis, >100 mm. Grade 3 Solicited Systemic Reactions: Fever, ≥39˚C, Headache, Malaise, Myalgia, and Shivering, Significant prevents daily activity.
    End point type
    Secondary
    End point timeframe
    Day 0 up to Day 7 post-vaccination
    End point values
    18 to 59 years (9 µg) 60 years or older (15 µg)
    Number of subjects analysed
    65
    65
    Units: Percentage of subjects
    number (not applicable)
        Injection site Pain
    33.8
    20
        Grade 3 Injection site Pain
    0
    0
        Injection site Erythema
    35.4
    41.5
        Grade 3 Injection site Erythema
    0
    0
        Injection site Swelling
    7.7
    7.7
        Grade 3 Injection site Swelling
    0
    0
        Injection site Induration
    7.7
    6.2
        Grade 3 Injection site Induration
    0
    0
        Injection site Ecchymosis
    0
    0
        Grade 3 Injection site Ecchymosis
    0
    0
        Injection site Pruritus
    29.2
    33.8
        Grade 3 Injection site Pruritus
    0
    0
        Fever
    1.5
    0
        Grade 3 Fever
    0
    0
        Headache
    24.6
    9.2
        Grade 3 Headache
    1.5
    0
        Malaise
    9.2
    4.6
        Grade 3 Malaise
    0
    0
        Myalgia
    23.1
    9.2
        Grade 3 Myalgia
    0
    0
        Shivering
    6.2
    1.5
        Grade 3 Shivering
    0
    0
    No statistical analyses for this end point

    Secondary: Summary of Solicited Reactions Listed in the CHMP Note for Guidance Within 3 days after Vaccination with Inactivated, Split-Virion Influenza Vaccine Administered by Intradermal Route

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    End point title
    Summary of Solicited Reactions Listed in the CHMP Note for Guidance Within 3 days after Vaccination with Inactivated, Split-Virion Influenza Vaccine Administered by Intradermal Route
    End point description
    Solicited Injection Site Reactions: Injection site Pain, Injection site Erythema, Injection site Swelling, Injection site Induration, Injection site Ecchymosis, and Injection site Pruritus. Solicited Systemic Reactions: Fever, Headache, Malaise, Myalgia, and Shivering.
    End point type
    Secondary
    End point timeframe
    Day 0 up to Day 3 post-vaccination
    End point values
    18 to 59 years (9 µg) 60 years or older (15 µg)
    Number of subjects analysed
    65
    65
    Units: Percentage of subjects
    number (not applicable)
        Injection site Induration (≥50 mm for 4 days)
    0
    0
        Injection site Ecchymosis/Injection site Bruising
    0
    1.5
        Pyrexia (>38˚C) for at least 1 day
    1.5
    0
        Malaise
    7.7
    3.1
        Shivering (Rigors)
    6.2
    1.5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse event data were collected from Day 0 (post-vaccination) up to Day 21 post-vaccination.
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    15.0
    Reporting groups
    Reporting group title
    18 to 59 years (9 µg)
    Reporting group description
    Subjects aged 18 to 59 years who were vaccinated with one dose of the intradermal (ID) influenza vaccine 9 µg, Northern Hemisphere (NH) 2013-2014 formulation.

    Reporting group title
    60 years or older (15 µg)
    Reporting group description
    Subjects aged 60 years or older who were vaccinated with one dose of the intradermal (ID) influenza vaccine 15 µg, Northern Hemisphere (NH) 2013-2014 formulation.

    Serious adverse events
    18 to 59 years (9 µg) 60 years or older (15 µg)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 65 (0.00%)
    0 / 65 (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
    18 to 59 years (9 µg) 60 years or older (15 µg)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    23 / 65 (35.38%)
    27 / 65 (41.54%)
    Nervous system disorders
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    16 / 65 (24.62%)
    6 / 65 (9.23%)
         occurrences all number
    16
    6
    General disorders and administration site conditions
    Injection site pain
    alternative assessment type: Systematic
         subjects affected / exposed
    22 / 65 (33.85%)
    13 / 65 (20.00%)
         occurrences all number
    22
    13
    Injection site erythema
    alternative assessment type: Systematic
         subjects affected / exposed
    23 / 65 (35.38%)
    27 / 65 (41.54%)
         occurrences all number
    23
    27
    Injection site swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    5 / 65 (7.69%)
    5 / 65 (7.69%)
         occurrences all number
    5
    5
    Injection site induration
    alternative assessment type: Systematic
         subjects affected / exposed
    5 / 65 (7.69%)
    4 / 65 (6.15%)
         occurrences all number
    5
    4
    Malaise
    alternative assessment type: Systematic
         subjects affected / exposed
    6 / 65 (9.23%)
    3 / 65 (4.62%)
         occurrences all number
    6
    3
    Shivering
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 65 (6.15%)
    1 / 65 (1.54%)
         occurrences all number
    4
    1
    Skin and subcutaneous tissue disorders
    Injection site pruritus
    alternative assessment type: Systematic
         subjects affected / exposed
    19 / 65 (29.23%)
    22 / 65 (33.85%)
         occurrences all number
    19
    22
    Musculoskeletal and connective tissue disorders
    Myalgia
    alternative assessment type: Systematic
         subjects affected / exposed
    15 / 65 (23.08%)
    6 / 65 (9.23%)
         occurrences all number
    15
    6

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

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