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   43881   clinical trials with a EudraCT protocol, of which   7295   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:
    Intratumoral Influenza Vaccine for Early Colorectal Cancer

    Summary
    EudraCT number
    2020-000725-27
    Trial protocol
    DK  
    Global end of trial date
    01 Sep 2021

    Results information
    Results version number
    v1(current)
    This version publication date
    28 Jun 2023
    First version publication date
    28 Jun 2023
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    2020-000725-27
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Zealand University Hospital
    Sponsor organisation address
    LYkkebækvej 1, Køge, Denmark,
    Public contact
    Research fellow, Center for Surgical Science, Department of Surgery, Zealand University Hospital, 0045 31429929, mgog@regionsjaelland.dk
    Scientific contact
    Research fellow, Center for Surgical Science, Department of Surgery, Zealand University Hospital, 0045 31429929, mgog@regionsjaelland.dk
    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
    01 Feb 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Sep 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Sep 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Primary: To investigate if intratumoral influenza vaccine is a safe treatment modality for tumor down staging prior to intended curative surgery in patients undergoing treatment for colorectal cancer.
    Protection of trial subjects
    Treated in routine care
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    25 Feb 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
    Denmark: 10
    Worldwide total number of subjects
    10
    EEA total number of subjects
    10
    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)
    2
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    Patients were recruited after the colorectal cancer MDT conference

    Pre-assignment
    Screening details
    Patients were screened at the colorectal cancer MDT conference

    Period 1
    Period 1 title
    Full study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Not applicable
    Blinding used
    Not blinded
    Blinding implementation details
    This was a non-blinded single arm study

    Arms
    Arm title
    Active
    Arm description
    Treatment with intratumoral influenza vaccine
    Arm type
    Experimental

    Investigational medicinal product name
    InfluVacTetra
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection/infusion
    Routes of administration
    Intratumoral use
    Dosage and administration details
    A single dose influenza vaccine (50 microliter) that was mixed with 150 microliter saline

    Number of subjects in period 1
    Active
    Started
    10
    Completed
    10

    Baseline characteristics

    Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Full study
    Reporting group description
    -

    Reporting group values
    Full study Total
    Number of subjects
    10 10
    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)
    2 2
        From 65-84 years
    8 8
        85 years and over
    0 0
    Gender categorical
    Units: Subjects
        Female
    3 3
        Male
    7 7
    Subject analysis sets

    Subject analysis set title
    Full analysis
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Baseline characteristics Tumor-infiltrating lymphocytes mRNA gene expression Spatial protein expression FLOW analysis of blood

    Subject analysis sets values
    Full analysis
    Number of subjects
    10
    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)
    2
        From 65-84 years
    8
        85 years and over
    0
    Age continuous
    Units:
        
    ±
    Gender categorical
    Units: Subjects
        Female
    3
        Male
    7

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    Active
    Reporting group description
    Treatment with intratumoral influenza vaccine

    Subject analysis set title
    Full analysis
    Subject analysis set type
    Full analysis
    Subject analysis set description
    Baseline characteristics Tumor-infiltrating lymphocytes mRNA gene expression Spatial protein expression FLOW analysis of blood

    Primary: Safety of treatment (CTCAE v4)

    Close Top of page
    End point title
    Safety of treatment (CTCAE v4)
    End point description
    End point type
    Primary
    End point timeframe
    Day 0-14
    End point values
    Active Full analysis
    Number of subjects analysed
    10
    10
    Units: Events
        Adverse events
    1
    1
        Serious adverse events
    0
    0
    Statistical analysis title
    Confidence interval for adverse events
    Comparison groups
    Active v Full analysis
    Number of subjects included in analysis
    20
    Analysis specification
    Post-hoc
    Analysis type
    other [1]
    Method
    Parameter type
    Confidence interval
    Point estimate
    10
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0
         upper limit
    30
    Notes
    [1] - The investigators performed af statistical analysis of the confidence interval for adverse events as specified in "Simon, S. Confidence interval with zero events. http://new.pmean.com/zero-events/ (2001)"

    Adverse events

    Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Day 0-14
    Adverse event reporting additional description
    CTCAE v4
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    CTCAE
    Dictionary version
    4
    Reporting groups
    Reporting group title
    Experimental arm
    Reporting group description
    -

    Serious adverse events
    Experimental arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 10 (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
    Experimental arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 10 (10.00%)
    General disorders and administration site conditions
    Fever
    Additional description: A mild fever that subsided without intervention
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1

    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 © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA