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   43865   clinical trials with a EudraCT protocol, of which   7286   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:
    Application of FSME-Immun® in allergic patients

    Summary
    EudraCT number
    		 2012-005672-34
    Trial protocol
    		 AT  
    Global end of trial date
    26 Mar 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    31 Jan 2020
    First version publication date
    31 Jan 2020
    Other versions
    Summary report(s)
    		 PDF Publikation in Vaccine 2018
    Supplementary data of Article in Vaccine 2018

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    FSME_only_1.1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02511535
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Medical University of Vienna, ISPTM
    Sponsor organisation address
    Kinderspitalgasse 15, Vienna, Austria, 1090
    Public contact
    ISPTM, Clinical Trials Information, Institut für Spezifische Prophylaxe und Tropenmedizin, +43 140160 38281,
    Scientific contact
    ISPTM, Clinical Trials Information, Institut für Spezifische Prophylaxe und Tropenmedizin, +43 140160 38281,
    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
    26 Mar 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Mar 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Humoral immunity, based on TBE Neutralisationstest-Titers one month +/- 7 days after booster
    Protection of trial subjects
    proper intra-muscular application of the vaccine, monitoring of patients for 20 min after vaccination on site, diary for documentation of side effects for 7 days after vaccination
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 119
    Worldwide total number of subjects
    119
    EEA total number of subjects
    119
    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)
    119
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 • completed primary TBE immunization + at least one booster • adults of both sexes between 18 and 60 years of age • willingness to sign written informed consent form

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 allergic patients
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    FSME-Immun®
    Investigational medicinal product code
    J07BA01
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose of FSME-Immun® 0.5 ml; 2.4 micrograms Route of administration: intramuscular use

    Arm title
    		 allergic patients undergoing specific immuno therapy
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    FSME-Immun®
    Investigational medicinal product code
    J07BA01
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose of FSME-Immun® 0.5 ml; 2.4 micrograms Route of administration: intramuscular use

    Arm title
    		 healthy controls
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    FSME-Immun®
    Investigational medicinal product code
    J07BA01
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose of FSME-Immun® 0.5 ml; 2.4 micrograms Route of administration: intramuscular use

    Investigational medicinal product name
    FSME-Immun®
    Investigational medicinal product code
    J07BA01
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose of FSME-Immun® 0.5 ml; 2.4 micrograms Route of administration: intramuscular use

    Number of subjects in period 1
    		allergic patients allergic patients undergoing specific immuno therapy healthy controls
    Started
    49
    21
    49
    Completed
    49
    21
    49

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    overall trail
    Reporting group description
    		 -

    Reporting group values
    		 overall trail Total
    Number of subjects
    		 119 119
    Age categorical
    Adults (18-60 years)
    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)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
        Adults (18-60 years)
    		 119 119
    Gender categorical
    males and females
    Units: Subjects
        Female
    		 72 72
        Male
    		 47 47

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    allergic patients
    Reporting group description
    		 -

    Reporting group title
    allergic patients undergoing specific immuno therapy
    Reporting group description
    		 -

    Reporting group title
    healthy controls
    Reporting group description
    		 -

    Primary: Humoral immunity, based on TBE Neutralisationstest-Titers one month +/- 7 days after booster

    		 Close Top of page
    End point title
    		 Humoral immunity, based on TBE Neutralisationstest-Titers one month +/- 7 days after booster [1]
    End point description
    End point type
    Primary
    End point timeframe
    1 month after booster (+/- 7 days)
    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: Please see statistical analyses in the publication: “Allergic patients with and without allergen-specific immunotherapy mount protective immune responses to tick-borne encephalitis vaccination in absence of enhanced side effects or propagation of their Th2 bias” Garner-Spitzer et al, Vaccine 2018 May 11;36 (20):2816-2824. doi: 10.1016/j.vaccine.2018.03.076.
    End point values
    		 allergic patients allergic patients undergoing specific immuno therapy healthy controls
    Number of subjects analysed
    49
    21
    49
    Units: titer
        geometric mean (confidence interval 95%)
    318 (239 to 423)
    250 (144 to 434)
    282 (211 to 378)
    No statistical analyses for this end point

    Secondary: cellular immune response

    		 Close Top of page
    End point title
    		 cellular immune response
    End point description
    IFN-g concentrations in culture supernatants on day 7 after TBE booster
    End point type
    Secondary
    End point timeframe
    d0 (before booster vaccination) and 1 week after booster
    End point values
    		 allergic patients allergic patients undergoing specific immuno therapy healthy controls
    Number of subjects analysed
    49
    21
    49
    Units: pg/ml
        geometric mean (confidence interval 95%)
    54 (38 to 78)
    59 (33 to 108)
    77 (52 to 114)
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    see publication
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 in house
    Dictionary version
    1.1
    Frequency threshold for reporting non-serious adverse events: 5%
    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: No serious adverse events occured in this study.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/29673942
    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-Mon Apr 29 03:06:34 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA