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    Clinical Trial Results:
    Immunogenicity, molecular profiling and safety of a marketed quadrivalent influenza vaccine (Vaxigrip Tetra®) administered by the intramuscular route in participants 60 years of age and older

    Summary
    EudraCT number
    		 2021-003307-18
    Trial protocol
    		 BE  
    Global end of trial date
    02 Feb 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Apr 2025
    First version publication date
    20 Apr 2025
    Other versions
    Summary report(s)
    		 CSR_summary

    Trial information

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    Trial identification
    Sponsor protocol code
    INCENTIVE-QIV-1-EU
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Antwerp
    Sponsor organisation address
    Campus Drie Eiken, Drie Eikenstraat 663, Edegem (Antwerp), Belgium, 2650
    Public contact
    Ilse De Coster, University of Antwerp, +32 32652676, ilse.decoster@uantwerpen.be
    Scientific contact
    Ilse De Coster, University of Antwerp, +32 32652676, ilse.decoster@uantwerpen.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
    18 Dec 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Feb 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To measure the level of immune response [HAI-haemagglutinin Antibody Inhibition titres] of a single intramuscular dose of the quadrivalent inactivated influenza vaccine (Vaxigrip Tetra®) in healthy participants aged 60 years and above
    Protection of trial subjects
    Study-related SAEs were to be collected after the administration of the study vaccine until the end of the procedures at visit 5 (day 28 ± 4). Blood collection was limited to the amount required for study analysis. No additional blood was taken from participants. The IMP used in this study was Vaxigrip Tetra®, a marketed vaccine. Vital signs were assessed at each study visit and SAEs were followed up during the study (e.g. by targeted physical examination if deemed necessary by the investigator).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Oct 2021
    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: 76
    Worldwide total number of subjects
    76
    EEA total number of subjects
    76
    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)
    29
    From 65 to 84 years
    47
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 76 subjects were enrolled and screened. From these, 50 participants were randomized and subsequentially vaccinated in the study. All study participants were of Caucasian origin and enrolled in Belgium, at the Centre for The Evaluation of Vaccination between 12OCT2021 and 03JAN2022.

    Pre-assignment
    Screening details
    		 A total of 76 subjects were enrolled and screened. From these, 50 participants were randomized and subsequentially vaccinated in the study. Main inclusion criteria: Male or female of non-childbearing potential aged 60 years and above; subjects were healthy or with well-controlled pre-existing medical conditions by the opinion of the investigator.

    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
    This was a Phase IV, non-randomized open-label vaccine trial.

    Arms
    Arm title
    		 Single arm
    Arm description
    		 Vaxigrip Tetra®(Quadrivalent Influenza Vaccine, season 2021 – 2022) is an inactivated quadrivalent influenza vaccine indicated for the prevention of influenza disease caused by influenza types A and B viruses contained in the vaccine. All subjects received a single dose (0.5 ml) on Day 0 by intramuscular injection into the deltoid muscle.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Vaxigrip Tetra
    Investigational medicinal product code
    Other name
    Batch number: V3H342V
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    All subjects received a single dose (0.5 ml) on Day 0 by intramuscular injection into the deltoid muscle.

    Number of subjects in period 1 [1]
    		Single arm
    Started
    50
    Completed
    50
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: A total of 76 participants was enrolled in the study, of which 15 (participants were deemed screen failures during the first study visit (screening) Of the 61 participants deemed eligible after screening, 52 returned to the second study visit. In total, 50 participants received the study vaccine during visit 2 and were therefore included in the TVC. The other 2 participants did not receive the study vaccine because they did not meet the inclusion criteria (1 participant) or due to a physician.

    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
    		 50 50
    Age categorical
    Eligible participants must meet all of the below criteria at the time of enrollment: Male or female of non-child bearing potential 60 years and above at the time of study.
    Units: Subjects
        60 years and above
    		 50 50
    Gender categorical
    Units: Subjects
        Female
    		 23 23
        Male
    		 27 27

    End points

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    End points reporting groups
    Reporting group title
    Single arm
    Reporting group description
    		 Vaxigrip Tetra®(Quadrivalent Influenza Vaccine, season 2021 – 2022) is an inactivated quadrivalent influenza vaccine indicated for the prevention of influenza disease caused by influenza types A and B viruses contained in the vaccine. All subjects received a single dose (0.5 ml) on Day 0 by intramuscular injection into the deltoid muscle.

    Primary: HAI antibody titres at D0

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    End point title
    		 HAI antibody titres at D0 [1]
    End point description
    GEOMETRIC MEAN TITRES FOR THE HAI TITRES AGAINST INFLUENZA STRAINS INCLUDED IN THE VAXIGRIP TETRA (2021 – 2022) VACCINE IN THE ACCORDING-TO-PROTOCOL (ATP) POPULATION: A/Victoria/2570/2019/H1N1 A/Tasmania/503/2020/H3N2 B/Washington/02/2019 B/Phuket/3073/2013 GEOMETRIC MEAN TITRES FOR THE HAI TITRES AGAINST INFLUENZA STRAINS NOT INCLUDED IN THE VAXIGRIP TETRA (2021 – 2022) VACCINE IN THE ACCORDING-TO-PROTOCOL (ATP) POPULATION: A/California/07/2019 (H1N1) A/Brisbane/02/2018 (H1N1) A/Brisbane/57/2007 (H1N1) A/Singapore/IFNIMH-16-0019/2016 (H3N2) A/Switzerland/9715293/2013 (H3N2) A/Panama/2007/1999 (H3N2) A/Darwin/09/2021 (H3N2) B/Austria/1359417/2021
    End point type
    Primary
    End point timeframe
    HAI antibody titres at D0
    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 analyses of the clinical characteristics were completed according to the statistical analysis plan. The geometric mean titre (GMT) at Day 0 and Day 28, with 95% Wald confidence intervals that were calculated using the mean and the standard error of the logarithmic transformed (base 10) HAI titres and subsequently taken the anti-log of.
    End point values
    		 Single arm
    Number of subjects analysed
    49
    Units: other
    geometric mean (confidence interval 95%)
        A/Victoria/2570/2019/H1N1
    11.9 (9.2 to 15.5)
        A/Tasmania/503/2020/H3N2
    21.7 (16.2 to 29.3)
        B/Washington/02/2019
    34.7 (24.4 to 49.2)
        B/Phuket/3073/2013
    81.7 (59.4 to 112.3)
        A/California/07/2019 (H1N1)
    31.4 (22.1 to 44.7)
        A/Brisbane/02/2018 (H1N1)
    11.9 (9.2 to 15.5)
        A/Brisbane/57/2007 (H1N1)
    7.2 (6.0 to 8.7)
        A/Singapore/IFNIMH-16-0019/2016 (H3N2)
    10.7 (7.5 to 15.3)
        A/Switzerland/9715293/2013 (H3N2)
    34.5 (25.0 to 47.5)
        A/Panama/2007/1999 (H3N2)
    5.3 (4.7 to 5.9)
        A/Darwin/09/2021 (H3N2)
    13.8 (11.1 to 17.3)
        B/Austria/1359417/2021
    12.0 (9.0 to 15.9)
    No statistical analyses for this end point

    Primary: HAI antibody titres at D28

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    End point title
    		 HAI antibody titres at D28 [2]
    End point description
    End point type
    Primary
    End point timeframe
    HAI antibody titres at D28
    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 analyses of the clinical characteristics were completed according to the statistical analysis plan. The geometric mean titre (GMT) at Day 0 and Day 28, with 95% Wald confidence intervals that were calculated using the mean and the standard error of the logarithmic transformed (base 10) HAI titres and subsequently taken the anti-log of.
    End point values
    		 Single arm
    Number of subjects analysed
    49
    Units: other
    geometric mean (confidence interval 95%)
        A/Victoria/2570/2019/H1N1
    69.5 (51.1 to 94.5)
        A/Tasmania/503/2020/H3N2
    77.2 (56.5 to 105.5)
        B/Washington/02/2019
    90.9 (68.8 to 120.0)
        B/Phuket/3073/2013
    180.5 (149.3 to 218.1)
        A/California/07/2019 (H1N1)
    113.9 (80.7 to 160.9)
        A/Brisbane/02/2018 (H1N1)
    69.5 (51.1 to 94.5)
        A/Brisbane/57/2007 (H1N1)
    10.7 (8.6 to 13.4)
        A/Singapore/IFNIMH-16-0019/2016 (H3N2)
    24.7 (15.7 to 38.9)
        A/Switzerland/9715293/2013 (H3N2)
    78.3 (58.4 to 105.1)
        A/Panama/2007/1999 (H3N2)
    8.0 (6.0 to 10.5)
        A/Darwin/09/2021 (H3N2)
    29.5 (22.2 to 39.1)
        B/Austria/1359417/2021
    25.6 (19.1 to 34.3)
    No statistical analyses for this end point

    Primary: Proportion of participants with HAI titres ≥ 40 (1/dilution) at D28

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    End point title
    		 Proportion of participants with HAI titres ≥ 40 (1/dilution) at D28 [3]
    End point description
    End point type
    Primary
    End point timeframe
    Proportion of participants with HAI titres ≥ 40 (1/dilution) at D28
    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 seroprotection rate (SPR) at Day 0 and Day 28, with 95% Clopper-Pearson confidence intervals.
    End point values
    		 Single arm
    Number of subjects analysed
    49
    Units: percent
    number (confidence interval 95%)
        Overall
    51.0 (36.3 to 65.6)
        A/Victoria/2570/2019/H1N1
    75.5 (61.1 to 86.7)
        A/Tasmania/503/2020/H3N2
    79.6 (65.7 to 89.8)
        B/Washington/02/2019
    87.8 (75.2 to 95.4)
        B/Phuket/3073/2013
    100.0 (92.7 to 100.0)
        A/California/07/2019 (H1N1)
    91.8 (80.4 to 97.7)
        A/Brisbane/02/2018 (H1N1)
    75.5 (61.1 to 86.7)
        A/Brisbane/57/2007 (H1N1)
    16.3 (7.3 to 29.7)
        A/Singapore/IFNIMH-16-0019/2016 (H3N2)
    55.1 (40.2 to 69.3)
        A/Switzerland/9715293/2013 (H3N2)
    85.7 (72.8 to 94.1)
        A/Panama/2007/1999 (H3N2)
    18.4 (8.8 to 32.0)
        A/Darwin/09/2021 (H3N2)
    44.9 (30.7 to 59.8)
        B/Austria/1359417/2021
    49.0 (34.4 to 63.7)
    No statistical analyses for this end point

    Primary: HAI antibody titres fold increase between D0 and D28 (MGI)

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    End point title
    		 HAI antibody titres fold increase between D0 and D28 (MGI) [4]
    End point description
    End point type
    Primary
    End point timeframe
    HAI antibody titres fold increase between D0 and D28
    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 analyses of the clinical characteristics were completed according to the statistical analysis plan. The mean geometric increase (MGI) between Day 0 and Day 28, with 95% Wald confidence intervals that were calculated using the mean and the standard error of the logarithmic transformed (base10) within-subject ratios of the Day 28 HAI titre to the Day 0 HAI titre and subsequently taken the anti-log of.
    End point values
    		 Single arm
    Number of subjects analysed
    49
    Units: other
    number (confidence interval 95%)
        A/Victoria/2570/2019/H1N1
    5.8 (4.2 to 8.2)
        A/Tasmania/503/2020/H3N2
    3.5 (2.7 to 4.7)
        B/Washington/02/2019
    2.6 (2.0 to 3.4)
        B/Phuket/3073/2013
    2.2 (1.7 to 2.8)
        A/California/07/2019 (H1N1)
    3.6 (2.7 to 4.9)
        A/Brisbane/02/2018 (H1N1)
    5.8 (4.2 to 8.2)
        A/Brisbane/57/2007 (H1N1)
    1.5 (1.2 to 1.8)
        A/Singapore/IFNIMH-16-0019/2016 (H3N2)
    2.3 (1.6 to 3.2)
        A/Switzerland/9715293/2013 (H3N2)
    2.3 (1.7 to 3.0)
        A/Panama/2007/1999 (H3N2)
    1.5 (1.2 to 1.9)
        A/Darwin/09/2021 (H3N2)
    2.1 (1.6 to 2.8)
        B/Austria/1359417/2021
    2.1 (1.6 to 2.8)
    No statistical analyses for this end point

    Primary: Proportion of participants with seroconversion (titre < 10 [1/dilution] at D0 and post-vaccination titre ≥ 40 [1/dilution] at D28, or titre ≥ 10 [1/dilution] at D0 and a ≥ 4-fold increase in titre [1/dilution] at D28

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    End point title
    		 Proportion of participants with seroconversion (titre < 10 [1/dilution] at D0 and post-vaccination titre ≥ 40 [1/dilution] at D28, or titre ≥ 10 [1/dilution] at D0 and a ≥ 4-fold increase in titre [1/dilution] at D28 [5]
    End point description
    End point type
    Primary
    End point timeframe
    Proportion of participants with seroconversion (titre < 10 [1/dilution] at D0 and post-vaccination titre ≥ 40 [1/dilution] at D28, or titre ≥ 10 [1/dilution] at D0 and a ≥ 4-fold increase in titre [1/dilution] at D28. Day 28
    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 seroconversion rate (SCR) between Day 0 and Day 28, with 95% and 98.75% Clopper-Pearson confidence intervals.
    End point values
    		 Single arm
    Number of subjects analysed
    49
    Units: percent
    number (confidence interval 95%)
        Overall
    12.2 (4.6 to 24.8)
        A/Victoria/2570/2019/H1N1
    55.1 (40.2 to 69.3)
        A/Tasmania/503/2020/H3N2
    34.7 (21.7 to 49.6)
        B/Washington/02/2019
    34.7 (21.7 to 49.6)
        B/Phuket/3073/2013
    26.5 (14.9 to 41.1)
        A/California/07/2019 (H1N1)
    44.9 (30.7 to 59.8)
        A/Brisbane/02/2018 (H1N1)
    55.1 (40.2 to 69.3)
        A/Brisbane/57/2007 (H1N1)
    8.2 (2.3 to 19.6)
        A/Singapore/IFNIMH-16-0019/2016 (H3N2)
    30.6 (18.3 to 45.4)
        A/Switzerland/9715293/2013 (H3N2)
    18.4 (8.8 to 32.0)
        A/Panama/2007/1999 (H3N2)
    16.3 (7.3 to 29.7)
        A/Darwin/09/2021 (H3N2)
    20.4 (10.2 to 34.3)
        B/Austria/1359417/2021
    22.4 (11.8 to 36.6)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Study related SAEs were to be collected following administration of the study vaccine until completion of the Visit 5 (Day 28 ± 4) procedures.
    Adverse event reporting additional description
    As Vaxigrip Tetra® is a marketed vaccine, only study related serious adverse events were recorded during this study. Subjects were asked non-leading questions to determine the occurrence of any SAEs during each postvaccination study visit.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    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: As Vaxigrip Tetra® is a marketed vaccine, only study related serious adverse events were recorded during this study. No serious adverse events were reported in this study.

    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.
    Not applicable
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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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