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Clinical trials for Pneumolysin

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   44363   clinical trials with a EudraCT protocol, of which   7387   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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    3 result(s) found for: Pneumolysin. Displaying page 1 of 1.
    EudraCT Number: 2009-011022-33 Sponsor Protocol Number: 112993 Start Date*: 2009-05-06
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase II, double-blind study to evaluate the safety, reactogenicity and immunogenicity of two different formulations of GSK Biologicals’ pneumococcal protein candidate vaccine, when given as a b...
    Medical condition: Booster vaccination with a pneumococcal protein candidate vaccine in healthy young adults aged between 18 and 41 years old, previously primed with 2 doses of pneumococcal protein vaccine in study S...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2009-012701-19 Sponsor Protocol Number: 113171 Start Date*: 2009-10-15
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase II, randomized, controlled, observer-blind study to assess the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK) Biologicals’ Streptococcus pneumoniae protein containing va...
    Medical condition: Two-dose primary vaccination of healthy children between 12 and 23 months of age at the time of the first vaccination against Streptococcus pneumoniae (S pneumoniae) and Haemophilus influenzae (H. ...
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: View results
    EudraCT Number: 2012-002727-15 Sponsor Protocol Number: 114174 Start Date*: 2015-06-22
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase II, randomized, controlled, observer-blind study to evaluate the impact of two formulations of GlaxoSmithKline (GSK) Biologicals’ combined 10-valent pneumococcal polysaccharide and non-type...
    Medical condition: Healthy volunteers (for one-dose vaccination of healthy children between 2-4 years of age at the time of vaccination against Streptococcus pneumoniae (S. pneumoniae) and Haemophilus influenzae (H. ...
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004862 10042196 Streptococcus pneumoniae secondary bacterial infection of acute bronchitis LLT
    18.0 100000004862 10042197 Streptococcus pneumoniae septicaemia LLT
    18.0 100000004862 10042195 Streptococcus pneumoniae pneumonia LLT
    18.0 100000004862 10018954 Haemophilus influenzae secondary bacterial infection of acute bronchitis LLT
    18.0 100000004862 10042194 Streptococcus pneumoniae meningitis LLT
    18.0 100000004862 10054642 Streptococcus pneumoniae septicemia LLT
    18.0 100000004862 10018953 Haemophilus influenzae meningitis LLT
    18.0 100000004862 10018952 Haemophilus influenzae infection LLT
    18.0 100000004862 10058214 Septicaemia due to Haemophilus influenzae (H. influenzae) LLT
    18.0 100000004862 10035680 Pneumonia due to Haemophilus influenzae (H. influenzae) LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    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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