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    Clinical Trial Results:
    An Observer-Blind, Randomized, Comparator-Controlled, Single-Centre Study to Evaluate the Tolerability, Safety, and Immunogenicity of Inactivated Influenza Vaccine, CSL Limited in a Healthy Pediatrics and Adult Population (aged >=3 years to <= 80 years)

    Summary
    EudraCT number
    		 2015-000177-12
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    20 Jun 2007

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Aug 2016
    First version publication date
    03 Aug 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CSLCT-CHF-06-25
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    CSL Ltd
    Sponsor organisation address
    45 Poplar Rd, Parkville, Australia, 3052
    Public contact
    Clinical Program Director, Seqirus, SeqirusAU.ClinicalTrials@seqirus.com
    Scientific contact
    Clinical Program Director, Seqirus, SeqirusAU.ClinicalTrials@seqirus.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    26 Sep 2007
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Jun 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety of CSL Inactivated Influenza Virus Vaccine in a healthy paediatric, adult and senior adult population (=>3 years to =< 80 years of age).
    Protection of trial subjects
    The relevant documents including the trial protocol and informed consent form passed review of a Chinese based independent ethical committee on May 10, 2007. This study was conducted in accordance with SFDA requirements and GCP/Declaration of Helsinki principles.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 May 2007
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    China: 720
    Worldwide total number of subjects
    720
    EEA total number of subjects
    0
    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)
    70
    Adolescents (12-17 years)
    200
    Adults (18-64 years)
    300
    From 65 to 84 years
    150
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 720 volunteers were recruited into the study. The study was conducted in Guangxi, China.

    Pre-assignment
    Screening details
    		 Phase I component: 30 subjects aged 3 - 80 years administered Fluvax. Phase III component: 690 subjects. The CRO prepared the study randomization code at a 2:1 ratio of the Fluvax test vaccine : Fluarix comparator vaccine.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    The clinical trial was divided into two stages: Phase I and Phase III. Phase I: Only investigational vaccine (Fluvax) was administered. The design was an open design, without a comparator arm, for the purpose of observing adverse reactions (there was no immunogenicity component). Phase III: An observer blinded, randomized and parallel control trial to compare both safety and immunogenicity between CSL influenza vaccine (Fluvax) and a comparator influenza vaccine (Fluarix).

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Phase I (Fluvax)
    Arm description
    		 For the phase I component, Fluvax vaccine was administered to eligible volunteers. The phase was an open design without the use of a comparator arm.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fluvax (Inactivated split virus influenza vaccine for injection)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Fluvax - Inactivated split virus influenza vaccine for injection (containing H1N1, H3N2 and B strains) Manufacturer: CSL Ltd. A 0.5 mL dose was administered.

    Arm title
    		 Phase III (Fluvax)
    Arm description
    		 Subjects were administered the CSL Fluvax vaccine. All subjects completed one vaccine injection and provided their safety data. All of these subjects were included in the safety analysis set.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fluvax (Inactivated split virus influenza vaccine for injection)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Fluvax - Inactivated split virus influenza vaccine for injection (containing H1N1, H3N2 and B strains) Manufacturer: CSL Ltd. A 0.5 mL dose was administered.

    Arm title
    		 Phase III (Comparator)
    Arm description
    		 Subjects were administered the comparator influenza vaccine (Fluarix). All subjects completed one vaccine injection and provided their safety data. All of these subjects were included in the safety analysis set.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Fluarix (Inactivated split virus influenza vaccine for injection)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Comparator vaccine: Inactivated split virus influenza vaccine (Fluarix) for injection (containing the H1N1, H3N2 and B strains). Manufacturer: Shanghai GSK Biological Ltd. A 0.5 mL dose was administered.

    Number of subjects in period 1
    		Phase I (Fluvax) Phase III (Fluvax) Phase III (Comparator)
    Started
    30
    460
    230
    Completed
    30
    460
    230

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Phase I (Fluvax)
    Reporting group description
    		 For the phase I component, Fluvax vaccine was administered to eligible volunteers. The phase was an open design without the use of a comparator arm.

    Reporting group title
    Phase III (Fluvax)
    Reporting group description
    		 Subjects were administered the CSL Fluvax vaccine. All subjects completed one vaccine injection and provided their safety data. All of these subjects were included in the safety analysis set.

    Reporting group title
    Phase III (Comparator)
    Reporting group description
    		 Subjects were administered the comparator influenza vaccine (Fluarix). All subjects completed one vaccine injection and provided their safety data. All of these subjects were included in the safety analysis set.

    Reporting group values
    		 Phase I (Fluvax) Phase III (Fluvax) Phase III (Comparator) Total
    Number of subjects
    		 30 460 230 720
    Age categorical
    Pediatric: age >= 3 years and < 16 years Adult：age >= 16 years and < 60 years Elderly：age >= 60 years and <= 80 years
    Units: Subjects
        Pediatric
    		 10 184 92 286
        Adult
    		 12 184 92 288
        Elderly
    		 8 92 46 146
    Gender categorical
    Note: Gender data were not available for the Phase I component of the trial and have been presented as an equal number of males and females.
    Units: Subjects
        Female
    		 15 282 141 438
        Male
    		 15 178 89 282

    End points

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    End points reporting groups
    Reporting group title
    Phase I (Fluvax)
    Reporting group description
    		 For the phase I component, Fluvax vaccine was administered to eligible volunteers. The phase was an open design without the use of a comparator arm.

    Reporting group title
    Phase III (Fluvax)
    Reporting group description
    		 Subjects were administered the CSL Fluvax vaccine. All subjects completed one vaccine injection and provided their safety data. All of these subjects were included in the safety analysis set.

    Reporting group title
    Phase III (Comparator)
    Reporting group description
    		 Subjects were administered the comparator influenza vaccine (Fluarix). All subjects completed one vaccine injection and provided their safety data. All of these subjects were included in the safety analysis set.

    Subject analysis set title
    CSL Vaccine - immunogenicity
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects who were enrolled into the phase III component, were vaccinated with CSL vaccine, and provided a blood sample before and after vaccination, were included in the immunogenicity per protocol set.

    Subject analysis set title
    Comparator Vaccine - immunogenicity
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Subjects who were enrolled into the phase III component, were vaccinated with comparator vaccine, and provided a blood sample before and after vaccination, were included in the immunogenicity per protocol set.

    Primary: Phase I: Tolerability observation of the CSL vaccine

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    End point title
    		 Phase I: Tolerability observation of the CSL vaccine [1] [2]
    End point description
    End point type
    Primary
    End point timeframe
    Collection of solicited local and systemic adverse reactions within 72 hours after vaccination. Collection of any unsolicited adverse reactions from day 4 to day 28 after 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: Statistical analysis data are not available for this section.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data captured for this end point are only for subjects in the phase I component of the trial.
    End point values
    		 Phase I (Fluvax)
    Number of subjects analysed
    30 [3]
    Units: Subjects reporting event
        Local reaction - mild pain
    4
        Local reaction - mild erythema
    1
        Local reaction - mild induration
    1
        Local reaction - mild ecchymosis
    1
        Systemic reaction - mild myalgia
    1
        Systemic reaction - mild fatigue
    1
    Notes
    [3] - Number of subjects reporting an Adverse Event (AE). One subject had 4 AEs; 5 subjects had 1 AE each.
    No statistical analyses for this end point

    Primary: Phase III: Assessment of solicited fever events

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    End point title
    		 Phase III: Assessment of solicited fever events [4] [5]
    End point description
    End point type
    Primary
    End point timeframe
    Within 72 hours after 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: Statistical analysis data are not available for this section.
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data captured for this end point are only for subjects in the phase III component of the trial.
    End point values
    		 Phase III (Fluvax) Phase III (Comparator)
    Number of subjects analysed
    460
    230
    Units: Subjects reporting event
        Systemic reaction – fever, mild (paediatric)
    3
    3
        Systemic reaction – fever, mild (adult)
    7
    4
        Systemic reaction – fever, mild (elderly)
    6
    4
        Systemic reaction – fever, mild (overall)
    16
    11
        Systemic reaction – fever, moderate (paediatric)
    2
    0
        Systemic reaction – fever, moderate (adult)
    1
    0
        Systemic reaction – fever, moderate (elderly)
    0
    1
        Systemic reaction – fever, moderate (overall)
    3
    1
        Systemic reaction – fever, total (overall)
    19
    12
    No statistical analyses for this end point

    Primary: Phase III: Other solicited adverse events

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    End point title
    		 Phase III: Other solicited adverse events [6] [7]
    End point description
    Overall number of subjects reporting solicited adverse events (other than fever), both systemic and local, for the phase III component of the trial.
    End point type
    Primary
    End point timeframe
    Up to 28 days after vaccination.
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analysis data are not available for this section.
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Data captured for this end point are only for subjects in the phase III component of the trial.
    End point values
    		 Phase III (Fluvax) Phase III (Comparator)
    Number of subjects analysed
    460
    230
    Units: number of subjects
        arthralgia
    2
    0
        myalgia
    2
    0
        fatigue
    4
    0
        headache
    2
    0
        dizziness
    6
    0
        low back pain
    1
    0
        erythemia
    2
    1
        pain
    9
    2
        induration
    2
    1
        swelling
    6
    3
        ecchymosis
    0
    1
    No statistical analyses for this end point

    Secondary: Seroconversion

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    End point title
    		 Seroconversion
    End point description
    The overall number of phase III subjects (in the immunogenicity per protocol population) achieving seroconversion is listed for each influenza strain (H1N1, H3N2 and B strains) included in the vaccine.
    End point type
    Secondary
    End point timeframe
    21 days after vaccination
    End point values
    		 CSL Vaccine - immunogenicity Comparator Vaccine - immunogenicity
    Number of subjects analysed
    403
    207
    Units: number of subjects
        Total - H1N1 strain
    355
    189
        Total - H3N2 strain
    310
    170
        Total - B strain
    331
    159
    No statistical analyses for this end point

    Secondary: Seroprotection

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    End point title
    		 Seroprotection
    End point description
    The overall number of phase III subjects (in the immunogenicity per protocol population) achieving seroprotection are listed for each influenza strain (H1N1, H3N2 and B strains) included in the vaccine.
    End point type
    Secondary
    End point timeframe
    21 days after vaccination
    End point values
    		 CSL Vaccine - immunogenicity Comparator Vaccine - immunogenicity
    Number of subjects analysed
    403
    207
    Units: number of subject
        Total - H1N1 strain
    400
    200
        Total - H3N2 strain
    392
    205
        Total - B strain
    372
    183
    No statistical analyses for this end point

    Secondary: Geometric Mean Titre

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    End point title
    		 Geometric Mean Titre
    End point description
    The pre- and post- vaccination haemagglutinin assay Geometric Mean Titres for the phase III subjects (in the immunogenicity per protocol population) are listed for each influenza strain (H1N1, H3N2 and B strains) included in the vaccine.
    End point type
    Secondary
    End point timeframe
    21 days after vaccination
    End point values
    		 CSL Vaccine - immunogenicity Comparator Vaccine - immunogenicity
    Number of subjects analysed
    403
    207
    Units: Titre (GMT)
        Total - H1N1 strain (pre-vaccine)
    44
    38
        Total - H1N1 strain (post-vaccine)
    545
    775
        Total - H3N2 strain (pre-vaccine)
    42
    42
        Total - H3N2 strain (post-vaccine)
    458
    671
        Total - B strain (pre-vaccine)
    14
    13
        Total - B strain (post-vaccine)
    167
    129
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Within 28 days after vaccination
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Not available
    Dictionary version
    0
    Reporting groups
    Reporting group title
    Safety population
    Reporting group description
    		 Available adverse event data are presented as end point analyses and are not able to be fully reported in this section. There were no serious adverse events reported in this trial.

    Serious adverse events
    		 Safety population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 720 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Safety population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 720 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: The number of subjects experiencing an adverse event is presented as part of the primary end point data set in the end point section. The number of adverse events experienced by the subjects is not available.

    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.
    Limited data are available for this trial affecting data entry as noted throughout. Estimated numbers have been entered for the Trial Information ‘Age group breakdown for trial’ section; actual numbers are provided in the Age Characteristics section.
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    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.

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