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Clinical trials for 2010-018630-52

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   44365   clinical trials with a EudraCT protocol, of which   7389   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 ).  
     
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    2 result(s) found for: 2010-018630-52. Displaying page 1 of 1.
    EudraCT Number: 2010-018630-52 Sponsor Protocol Number: IC51-315 Start Date*: 2010-05-27
    Sponsor Name:Intercell AG
    Full Title: AN OPEN-LABEL, UNCONTROLLED PHASE 4 STUDY TO ASSESS THE SAFETY AND IMMUNOGENICITY OF THE JAPANESE ENCEPHALITIS (JE) VACCINE IXIARO® (IC51) IN AN ELDERLY POPULATION
    Medical condition: IXIARO® is used to protect adults against Japanese encephalitis (JE). JE can be fatal or lead to long-term disability. Vaccination with Ixiaro should be considered for people who are at risk of exp...
    Disease: Version SOC Term Classification Code Term Level
    12.1 10014596 Encephalitis Japanese B LLT
    12.1 10023119 Japanese B encephalitis LLT
    12.1 10023120 Japanese B viral encephalitis LLT
    12.1 10023122 Japanese B virus encephalitis LLT
    12.1 10023123 Japanese encephalitis LLT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2016-002894-36 Sponsor Protocol Number: IXIARO-booster-senescence Start Date*: 2017-12-22
    Sponsor Name:Medical University of Vienna (MUW)
    Full Title: "An open, monocentric, uncontrolled phase 4 trial to characterise cellular and humoral immune responses following the first booster immunisation with the inactivated, purified Japanese Encephalitis...
    Medical condition: The condition under investigation is the naturally aging immune system. The aim of this study is to investigate the immune responses following a booster immunisation with the Japanese Encephalitis ...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: (No results available)
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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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