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Clinical trials

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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    Study title: A phase II, double-blind, randomized study to compare the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals¿ Tritanrix¿-HepBlow thio/Hib2.5 Gödöllö to GSK Biologicals¿ Tritanrix¿-HepB/Hiberix¿Gödöllö when administered as a three-dose primary vaccination course to healthy infants at 6, 10 and 14 weeks of age. A dose of unconjugated Hib vaccine (plain PRP booster) will be administered at the age of 10 months to 50% of the subjects. Note: This report presents the results pertaining to the plain PRP challenge at 10 months of age.

    Type of medicine: Non-centrally authorised vaccines
    Therapeutic area: Bacterial Infections and Mycoses [01]
    Brands: Please see report, Please see report, Please see report
    MAH holders: Please see report
    Assessment:
    Active substance: Haemophilus influenzae type b capsular polysaccharide (PRP) conjugated to tetanus toxoid (TT)
    ATC code: J07AG01/ J07AG51
    Document link:
    Document date: 2011-09-23
    Study number: 208108/084
    EudraCT number:
    Scope of study: CLINICAL
    Population of study subjects: Preterm newborn Infants Newborn infants (1 to 27 days) Infants and toddlers (28 days to 24 months) Children (2 to 11 years) Adolescents (12 to 18 years)
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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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