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Clinical trials for 2011-002225-22

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   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 ).  
     
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    1 result(s) found for: 2011-002225-22. Displaying page 1 of 1.
    EudraCT Number: 2011-002225-22 Sponsor Protocol Number: 115373 Start Date*: 2011-11-29
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase I, randomized, controlled, double-blind study to assess safety, reactogenicity and immunogenicity of GSK Biologicals’ pneumococcal vaccine 2830930A when administered as a single dose in hea...
    Medical condition: 1-dose vaccination of healthy toddlers between 12-23 months of age at the time of vaccination against Streptococcus pneumoniae (S. pn) and Haemophilus influenzae (Hi) who previously received 3 dose...
    Disease: Version SOC Term Classification Code Term Level
    14.0 10021881 - Infections and infestations 10018953 Haemophilus influenzae meningitis LLT
    14.0 10021881 - Infections and infestations 10042194 Streptococcus pneumoniae meningitis LLT
    14.0 10021881 - Infections and infestations 10042196 Streptococcus pneumoniae secondary bacterial infection of acute bronchitis LLT
    14.0 10021881 - Infections and infestations 10018954 Haemophilus influenzae secondary bacterial infection of acute bronchitis LLT
    14.0 10021881 - Infections and infestations 10018952 Haemophilus influenzae infection LLT
    14.0 10021881 - Infections and infestations 10035680 Pneumonia due to Haemophilus influenzae (H. influenzae) LLT
    14.0 10021881 - Infections and infestations 10054642 Streptococcus pneumoniae septicemia LLT
    14.0 10021881 - Infections and infestations 10042195 Streptococcus pneumoniae pneumonia LLT
    14.0 10021881 - Infections and infestations 10058214 Septicaemia due to haemophilus influenzae (H. influenzae) LLT
    14.0 10021881 - Infections and infestations 10042197 Streptococcus pneumoniae septicaemia LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: DE (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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