Flag of the European Union EU Clinical Trials Register Help

Clinical trials for 2010-021569-58

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.

    The EU Clinical Trials Register currently displays   37537   clinical trials with a EudraCT protocol, of which   6155   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).
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
    1 result(s) found for: 2010-021569-58. Displaying page 1 of 1.
    EudraCT Number: 2010-021569-58 Sponsor Protocol Number: 113948 Start Date*: 2010-11-17
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase I/II, double-blind, randomized, multicentre study to evaluate the safety and immunogenicity of new formulations of GlaxoSmithKline Biologicals’ DTPa-HBV-IPV/Hib vaccine when administered to...
    Medical condition: Primary immunization of healthy infants in the first year of life against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b (Hib) diseases.
    Disease: Version SOC Term Classification Code Term Level
    13.1 10021881 - Infections and infestations 10043376 Tetanus PT
    13.1 10021881 - Infections and infestations 10018952 Haemophilus influenzae infection LLT
    13.1 10021881 - Infections and infestations 10034738 Pertussis PT
    13.1 10021881 - Infections and infestations 10019731 Hepatitis B PT
    13.1 10021881 - Infections and infestations 10013023 Diphtheria PT
    13.1 10021881 - Infections and infestations 10036012 Poliomyelitis PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: View results
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    Query did not match any studies.
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2020 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice