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Clinical trials for 2009-012460-14

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   44364   clinical trials with a EudraCT protocol, of which   7388   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: 2009-012460-14. Displaying page 1 of 1.
    EudraCT Number: 2009-012460-14 Sponsor Protocol Number: 112980 Start Date*: 2010-05-03
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase II, open-label, randomised study to assess the safety and immunogenicity of a birth dose of GSK Biologicals’ reduced-antigen-content tri-component pertussis vaccine followed by routine paed...
    Medical condition: Primary and booster immunisation of healthy infants in the first two years of life against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type b, rotavirus and p...
    Disease: Version SOC Term Classification Code Term Level
    12.1 10043376 Tetanus LLT
    12.1 10013023 Diphtheria LLT
    12.1 10034738 Pertussis LLT
    12.1 10019731 Hepatitis B LLT
    12.1 10036012 Poliomyelitis LLT
    12.1 10018952 Haemophilus influenzae infection LLT
    12.1 10067470 Rotavirus infection LLT
    12.1 10061353 Pneumococcal infection LLT
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: NL (Completed) GB (Prematurely Ended) BE (Prematurely Ended)
    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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