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    Clinical Trial Results:
    A clinical study of biomarkers of innate and adaptive immune activation associated with symptoms and immune responses after administration of a single dose of a quadrivalent inactivated split virus influenza vaccine to healthy young adults.

    Summary
    EudraCT number
    		 2017-000116-42
    Trial protocol
    		 BE  
    Global end of trial date
    17 May 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Sep 2024
    First version publication date
    08 Sep 2024
    Other versions
    Summary report(s)
    		 Protocol

    Trial information

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    Trial identification
    Sponsor protocol code
    BioVacSafe-QIV
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ghent University Hospital
    Sponsor organisation address
    Corneel Heymanslaan 10, Ghent, Belgium, 9000
    Public contact
    Hiruz CTU, Ghent University Hospital, +32 93320500, hiruz.ctu@uzgent.be
    Scientific contact
    Hiruz CTU, Ghent University Hospital, +32 93320500, hiruz.ctu@uzgent.be
    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
    17 May 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 May 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    17 May 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The purpose of this protocol is to generate a set of data that will be analysed by integrated systems biology approach, for validation in subsequent clinical trials or in animal models. The dataset will broadly characterise: : 1. Physiological responses at various time points after immunisation 2. Innate and adaptive immune responses 3. Genetic testing of subjects when deemed necessary (genetic testing analysis may be SNIP analysis or full genome analysis). 4. Correlations in changes in innate and adaptive immune activation with adverse events, haematology and biochemistry panels, genotype and physiological assessments
    Protection of trial subjects
    Ethics review and approval, informed consent, supportive care and routine monitoring.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Mar 2017
    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: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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)
    20
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 20 patients were screened in the period from 27-03-2017 till 18-04-2017. 20 patients were included. 20 patients were included and completed the trial. End of trial notification was dated 17-05-2017 (last patient last visit) and submitted to EC and CA 8/09/2017.

    Pre-assignment
    Screening details
    		 Inclusion criteria: - Healthy male/female subjects: 24-54 years inclusive. - BMI ≥18 and ≤30 - signed the ICF - available for follow-up - agrees to abstain from donating blood during participation - heterosexually active female, willing to use contraception - willing to undergo urine pregnancy test - sufficient venous access

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

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Baseline arm
    Arm description
    		 -
    Arm type
    		 Baseline arm

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Treatment arm
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    a-RIX-Tetra
    Investigational medicinal product code
    Other name
    Alfa-Rix Tetra 2016-2017
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    A quadrivalent inactivated split virus influenza vaccine for the 2016/2017 season. 1 dose, 0.5 mL, to be administered on Day 0, the first visit.

    Number of subjects in period 1
    		Baseline arm Treatment arm
    Started
    20
    20
    Completed
    20
    20

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall Trial Total
    Number of subjects
    		 20 20
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 20 20
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 20 20

    End points

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    End points reporting groups
    Reporting group title
    Baseline arm
    Reporting group description
    		 -

    Reporting group title
    Treatment arm
    Reporting group description
    		 -

    Primary: Variable end points

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    End point title
    		 Variable end points [1]
    End point description
    See protocol in attachment
    End point type
    Primary
    End point timeframe
    Overall Study
    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: NAP
    End point values
    		 Baseline arm Treatment arm
    Number of subjects analysed
    20
    20
    Units: Subjects
        number (not applicable)
    20
    20
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Overall Study
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Frequency threshold for reporting non-serious adverse events: 0%
    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: NAP

    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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    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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