Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Phase III, open, non-randomized, multi-centric, single dose study to assess immunogenicity and safety of Fluarix™ / Influsplit SSW® 2009/2010 injected intramuscularly in young adults (18 to 60 years) and in elderly (over 60 years).

    Summary
    EudraCT number
    		 2009-010811-34
    Trial protocol
    		 DE  
    Global end of trial date
    08 Jul 2009

    Results information
    Results version number
    		 v2(current)
    This version publication date
    12 Nov 2020
    First version publication date
    04 Dec 2014
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Minor changes in safety section.

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    113018
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00920374
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l'Institut 89, Rixensart, Belgium,
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089904466, GSKClinicalSupportHD@gsk.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
    08 Jul 2009
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Jul 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the humoral response (anti-hemagglutinin antibody tested by hemagglutination inhibition) against each vaccine strain in adults aged 18 years or above, 21 days after vaccination with Fluarix™/Influsplit SSW® 2009-2010.
    Protection of trial subjects
    As with all injectable vaccines, appropriate medical treatment was always readily available in case of rare anaphylactic reactions following the administration of the vaccine. For this reason, the vaccine remained under medical supervision for 30 minutes after vaccination.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Jun 2009
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 118
    Worldwide total number of subjects
    118
    EEA total number of subjects
    118
    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)
    61
    From 65 to 84 years
    57
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 118
    Number of subjects completed
    		 118

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Fluarix Adult Group
    Arm description
    		 Subjects who are 18-60 years of age received one dose of Fluarix™
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fluarix™/Influsplit SSW®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular and intravenous use
    Dosage and administration details
    single intramuscular dose on Day 0

    Arm title
    		 Fluarix Elderly Group
    Arm description
    		 Subjects who are > 60 years of age received one dose of Fluarix™
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fluarix™/Influsplit SSW®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    single intramuscular dose on Day 0

    Number of subjects in period 1
    		Fluarix Adult Group Fluarix Elderly Group
    Started
    61
    57
    Completed
    61
    57

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Fluarix Adult Group
    Reporting group description
    		 Subjects who are 18-60 years of age received one dose of Fluarix™

    Reporting group title
    Fluarix Elderly Group
    Reporting group description
    		 Subjects who are > 60 years of age received one dose of Fluarix™

    Reporting group values
    		 Fluarix Adult Group Fluarix Elderly Group Total
    Number of subjects
    		 61 57 118
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        geometric mean (standard deviation)
    		 39.3 ± 12.18 68.9 ± 6.57 -
    Gender categorical
    Units: Subjects
        Female
    		 32 28 60
        Male
    		 29 29 58

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Fluarix Adult Group
    Reporting group description
    		 Subjects who are 18-60 years of age received one dose of Fluarix™

    Reporting group title
    Fluarix Elderly Group
    Reporting group description
    		 Subjects who are > 60 years of age received one dose of Fluarix™

    Primary: Hemagglutination Inhibition (HI) Antibody Titre

    		 Close Top of page
    End point title
    		 Hemagglutination Inhibition (HI) Antibody Titre [1]
    End point description
    Titres given as geometric mean titer (GMT) were presented for all three vaccine influenza virus strains
    End point type
    Primary
    End point timeframe
    Day 0 and Day 21
    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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Fluarix Adult Group Fluarix Elderly Group
    Number of subjects analysed
    59
    56
    Units: titre
    geometric mean (confidence interval 95%)
        A/Brisbane (Day 0)
    15.5 (11.7 to 20.6)
    11.4 (9.2 to 14)
        A/Brisbane (Day 21)
    139.7 (100.6 to 194)
    55.8 (39.2 to 79.5)
        A/Uruguay (Day 0)
    18.2 (13.7 to 24.1)
    13.2 (10.1 to 17.2)
        A/Uruguay (Day 21)
    151.7 (111.6 to 206.2)
    112.4 (76.3 to 165.5)
        B/Brisbane (Day 0)
    62.8 (45.4 to 86.8)
    77.6 (57.3 to 105)
        B/Brisbane (Day 21)
    393 (319.3 to 483.7)
    371.3 (274.9 to 501.6)
    No statistical analyses for this end point

    Primary: Number of Subjects With HI Antibody Titre Above the Cut-off Value

    		 Close Top of page
    End point title
    		 Number of Subjects With HI Antibody Titre Above the Cut-off Value [2]
    End point description
    The cut-off value assessed was ≥ 1:10 and was presented for all three vaccine influenza virus strains
    End point type
    Primary
    End point timeframe
    Day 0 and Day 21
    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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Fluarix Adult Group Fluarix Elderly Group
    Number of subjects analysed
    59
    56
    Units: Subjects
        A/Brisbane (Day 0)
    39
    36
        A/Brisbane (Day 21)
    58
    56
        A/Uruguay (Day 0)
    44
    37
        A/Uruguay (Day 21)
    59
    56
        B/Brisbane (Day 0)
    56
    54
        B/Brisbane (Day 21)
    59
    56
    No statistical analyses for this end point

    Primary: Number of Seroprotected Subjects

    		 Close Top of page
    End point title
    		 Number of Seroprotected Subjects [3]
    End point description
    A seroprotected subject is a subject with a serum HI antibody titre ≥ 1:40
    End point type
    Primary
    End point timeframe
    Day 0 and Day 21
    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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Fluarix Adult Group Fluarix Elderly Group
    Number of subjects analysed
    59
    56
    Units: Subjects
        A/Brisbane (Day 0)
    18
    6
        A/Brisbane (Day 21)
    53
    35
        A/Uruguay (Day 0)
    17
    10
        A/Uruguay (Day 21)
    52
    46
        B/Brisbane (Day 0)
    38
    45
        B/Brisbane (Day 21)
    59
    56
    No statistical analyses for this end point

    Primary: Number of Seroconverted Subjects

    		 Close Top of page
    End point title
    		 Number of Seroconverted Subjects [4]
    End point description
    A seroconverted subject is a subject with a pre-vaccination serum HI titre< 1:10 and a post-vaccination serum HI titre ≥ 1:40, or a pre-vaccination serum HI titre ≥ 1:10 and a fold increase (Day 21/Day 0) ≥ 4
    End point type
    Primary
    End point timeframe
    Day 21
    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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Fluarix Adult Group Fluarix Elderly Group
    Number of subjects analysed
    59
    56
    Units: Subjects
        A/Brisbane
    41
    24
        A/Uruguay
    40
    41
        B/Brisbane
    34
    30
    No statistical analyses for this end point

    Primary: Seroconversion Factor

    		 Close Top of page
    End point title
    		 Seroconversion Factor [5]
    End point description
    Seroconversion factor, defined as the fold increase in serum HI GMT post-vaccination compared to pre-vaccination (Day 0), is presented for all three vaccine influenza virus strains
    End point type
    Primary
    End point timeframe
    Day 21
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Fluarix Adult Group Fluarix Elderly Group
    Number of subjects analysed
    59
    56
    Units: fold increase
    geometric mean (confidence interval 95%)
        A/Brisbane
    9 (6.2 to 13.1)
    4.9 (3.5 to 6.9)
        A/Uruguay
    8.3 (6 to 11.6)
    8.5 (6.2 to 11.7)
        B/Brisbane
    6.3 (4.5 to 8.7)
    4.8 (3.6 to 6.4)
    No statistical analyses for this end point

    Primary: Seroprotection Power

    		 Close Top of page
    End point title
    		 Seroprotection Power [6]
    End point description
    Seroprotection power is defined as the number of subject who had a pre-vaccination titre < 1:40 and a post-vaccination titre ≥ 1:40
    End point type
    Primary
    End point timeframe
    Day 21
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Fluarix Adult Group Fluarix Elderly Group
    Number of subjects analysed
    42
    50
    Units: Subjects
        A/Brisbane (N=41; 50)
    35
    29
        A/Uruguay (N=42; 46)
    35
    36
        B/Brisbane (N=21; 11)
    21
    11
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting Solicited Local Symptoms

    		 Close Top of page
    End point title
    		 Number of Subjects Reporting Solicited Local Symptoms
    End point description
    Solicited local symptoms assessed include ecchymosis, induration, pain, redness, and swelling.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Day 0-3) post-vaccination period
    End point values
    		 Fluarix Adult Group Fluarix Elderly Group
    Number of subjects analysed
    61
    57
    Units: Subjects
        Ecchymosis
    3
    2
        Induration
    14
    13
        Pain
    41
    21
        Redness
    22
    16
        Swelling
    9
    9
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting Solicited General Symptoms

    		 Close Top of page
    End point title
    		 Number of Subjects Reporting Solicited General Symptoms
    End point description
    Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, shivering, sweating, and fever
    End point type
    Secondary
    End point timeframe
    During the 4-day (Day 0-3) post-vaccination period
    End point values
    		 Fluarix Adult Group Fluarix Elderly Group
    Number of subjects analysed
    61
    57
    Units: Subjects
        Arthralgia
    5
    8
        Fatigue
    13
    6
        Headache
    12
    3
        Myalgia
    14
    7
        Shivering
    2
    2
        Sweating
    6
    5
        Fever
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting Unsolicited Adverse Events (AE)

    		 Close Top of page
    End point title
    		 Number of Subjects Reporting Unsolicited Adverse Events (AE)
    End point description
    An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
    End point type
    Secondary
    End point timeframe
    During the 21-day (Day 0-20) post-vaccination period
    End point values
    		 Fluarix Adult Group Fluarix Elderly Group
    Number of subjects analysed
    61
    57
    Units: Subjects
        AE
    9
    3
    No statistical analyses for this end point

    Secondary: Number of Subjects Reporting Serious Adverse Events (SAE)

    		 Close Top of page
    End point title
    		 Number of Subjects Reporting Serious Adverse Events (SAE)
    End point description
    An SAE is any untoward medical occurrence that: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
    End point type
    Secondary
    End point timeframe
    During the entire study period
    End point values
    		 Fluarix Adult Group Fluarix Elderly Group
    Number of subjects analysed
    61
    57
    Units: Subjects
        (SAE)
    0
    0
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Serious Adverse Events: From Day 0 to Day 21; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Day 0-20) post-vaccination period
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Fluarix Adult Group
    Reporting group description
    		 Subjects who are 18-60 years of age received one dose of Fluarix™

    Reporting group title
    Fluarix Elderly Group
    Reporting group description
    		 Subjects who are > 60 years of age received one dose of Fluarix™

    Serious adverse events
    		 Fluarix Adult Group Fluarix Elderly Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 61 (0.00%)
    0 / 57 (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
    		 Fluarix Adult Group Fluarix Elderly Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    47 / 61 (77.05%)
    31 / 57 (54.39%)
    General disorders and administration site conditions
    Arthralgia
    alternative assessment type: Systematic
         subjects affected / exposed
    5 / 61 (8.20%)
    8 / 57 (14.04%)
         occurrences all number
    5
    8
    Fatigue
    alternative assessment type: Systematic
         subjects affected / exposed
    13 / 61 (21.31%)
    6 / 57 (10.53%)
         occurrences all number
    13
    6
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    12 / 61 (19.67%)
    3 / 57 (5.26%)
         occurrences all number
    12
    3
    Myalgia
    alternative assessment type: Systematic
         subjects affected / exposed
    14 / 61 (22.95%)
    7 / 57 (12.28%)
         occurrences all number
    14
    7
    Sweating
    alternative assessment type: Systematic
         subjects affected / exposed
    6 / 61 (9.84%)
    5 / 57 (8.77%)
         occurrences all number
    6
    5
    Induration
    alternative assessment type: Systematic
         subjects affected / exposed
    14 / 61 (22.95%)
    13 / 57 (22.81%)
         occurrences all number
    14
    13
    Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    41 / 61 (67.21%)
    21 / 57 (36.84%)
         occurrences all number
    41
    21
    Redness
    alternative assessment type: Systematic
         subjects affected / exposed
    22 / 61 (36.07%)
    16 / 57 (28.07%)
         occurrences all number
    22
    16
    Swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    9 / 61 (14.75%)
    9 / 57 (15.79%)
         occurrences all number
    9
    9

    More information

    		 Close Top of page

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu Apr 25 06:37:13 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA