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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   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).

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    Clinical Trial Results:
    INCENTIVE-QIV-3-EU: Immunogenicity, molecular profiling of a marketed quadrivalent influenza vaccine (Vaxigrip Tetra®) administered by the intramuscular route in participants aged 6 to 8 months

    Summary
    EudraCT number
    		 2021-003760-27
    Trial protocol
    		 BE  
    Global completion date

    Paediatric regulatory details
    Is the trial part of an agreed EMA paediatric investigation plan?
    Is the trial in scope of article 45 of Regulation (EC) No 1901/2006?
    Is the trial in scope of article 46 of Regulation (EC) No 1901/2006?

    Results information
    Results version number
    		 v2(current)
    This version publication date
    06 Feb 2025
    First version publication date
    09 Jan 2025
    Other versions
    		 v1
    Version creation reason
    • Changes to summary attachments
    Annex IV of the submission contains an error. The strains included in the Vaxigrip Tetra vaccine of the 2021-2022 flu season are A/Victoria/2570/2019 (H1N1), A/Cambodia/e0826360/2020 (H3N2), B/Washington/02/2019 (B/Victoria lineage), and B/Phuket/3073/2013 (B/Yamagata lineage).
    Summary report(s)
    		 INCENTIVE_QIV-3_CSR_20DEC2024_version 1.0
    Annex I_Incentive QIV3_ICF_EN_v4.0
    Annex II_Investigator signatures
    Annex III_SmPC Vaxigrip Tetra 2021
    Annex III_SmPC Vaxigrip Tetra 2022
    Annex IV_Vaccine and HAI strains
    Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03 for further information.
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    The status and protocol content of GB trials is no longer updated since 1 January 2021.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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