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Clinical trials for Circovirus

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   44335   clinical trials with a EudraCT protocol, of which   7366   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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    5 result(s) found for: Circovirus. Displaying page 1 of 1.
    EudraCT Number: 2020-000972-38 Sponsor Protocol Number: 212692 Start Date*: 2023-05-17
    Sponsor Name:GlaxoSmithKline Biologicals SA
    Full Title: A Phase III, observer-blind, randomized, multicenter study to evaluate immunogenicity, reactogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ Rotarix Porcine circovirus (PCV)-free liquid a...
    Medical condition: Healthy volunteers (active immunization of infants against gastroenteritis due to rotavirus infection)
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2022-000708-36 Sponsor Protocol Number: 218485 Start Date*: 2023-06-08
    Sponsor Name:GlaxoSmithKline Biologicals SA
    Full Title: A phase III, open-label, randomized, controlled study to evaluate the immunogenicity and safety of inactivated poliovirus vaccine (IPV) when co-administered with Porcine circovirus (PCV)-free liqui...
    Medical condition: Healthy volunteers (active immunization of infants against gastroenteritis due to rotavirus infection)
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2018-001986-18 Sponsor Protocol Number: 208236 Start Date*: 2019-07-14
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III, observer-blind, randomized, multi-country study to assess the reactogenicity and safety of the Porcine circovirus (PCV) free liquid formulation of GSK’s oral live attenuated human rota...
    Medical condition: Healthy volunteers [Active immunization of infants against gastroenteritis (GE) due to rotavirus (RV)].
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-003210-27 Sponsor Protocol Number: 201663 Start Date*: 2017-07-20
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase IIIA, randomized, single-blind, multi-centric study to evaluate the immunogenicity, reactogenicity and safety of three doses of Pediarix, Hiberix and Prevenar 13 when co-administered with t...
    Medical condition: PCV-free HRV vaccine is indicated to prevent gastroenteritis (GE) caused by rotavirus (RV)
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-000598-19 Sponsor Protocol Number: 115461 Start Date*: 2016-10-28
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: Immunogenicity and safety study of two formulations of GlaxoSmithKline (GSK) Biologicals’ human rotavirus (HRV) vaccine (444563), in healthy infants starting at age 6-12 weeks.
    Medical condition: Rotarix is indicated to prevent infants against gastroenteritis (GE) due to rotavirus (RV).
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004862 10039232 Rotavirus gastroenteritis LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed) DE (Completed) Outside EU/EEA ES (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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