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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 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   33573   clinical trials with a EudraCT protocol, of which   5436   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.
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    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.
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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 (Ongoing) GB (Prematurely Ended) BE (Prematurely Ended)
    Trial results: (No results available)
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    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.
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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