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Clinical trials for 2009-014719-11

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
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  • 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   43392   clinical trials with a EudraCT protocol, of which   7179   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.
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    1 result(s) found for: 2009-014719-11. Displaying page 1 of 1.
    EudraCT Number: 2009-014719-11 Sponsor Protocol Number: 2009/08 H1N1 Start Date*: 2009-09-18
    Sponsor Name:University of Oxford
    Full Title: Open Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Baxter H1N1 vaccine and GlaxoSmithKline H1N1 vaccine in children 6 months to 12...
    Medical condition: Prophylaxis of influenza in an officially declared pandemic situation.
    Disease: Version SOC Term Classification Code Term Level
    12.0 10059429 Influenza immunisation LLT
    12.0 10059637 Influenza antibody test LLT
    12.0 10059642 Influenza antibody test positive LLT
    12.0 10059643 Influenza antibody test negative LLT
    12.0 10060063 Influenza serology LLT
    12.0 10060078 Influenza serology positive LLT
    12.0 10060079 Influenza serology negative LLT
    12.0 10022000 Influenza LLT
    12.0 10022002 Influenza A virus infection LLT
    12.0 10022001 Influenza (epidemic) LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
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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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