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Clinical trials for 2021-004003-41

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
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    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
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    The EU Clinical Trials Register currently displays   44334   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 ).  
     
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    1 result(s) found for: 2021-004003-41. Displaying page 1 of 1.
    EudraCT Number: 2021-004003-41 Sponsor Protocol Number: 217354 Start Date*: 2022-02-11
    Sponsor Name:GlaxoSmithKline, S.A.
    Full Title: A Phase III, randomized, open-label, active vaccine-controlled crossover study to evaluate the reactogenicity, safety and immune response of unadjuvanted RSV maternal vaccine in healthy non-pregnan...
    Medical condition: Healthy volunteers (prevention of RSV-associated lower respiratory tract illnesses (LRTIs))
    Disease: Version SOC Term Classification Code Term Level
    21.1 10021881 - Infections and infestations 10035732 Pneumonia respiratory syncytial viral PT
    21.1 10021881 - Infections and infestations 10038718 Respiratory syncytial virus bronchiolitis PT
    21.1 10021881 - Infections and infestations 10066741 Respiratory syncytial virus infection recurrent LLT
    21.1 10021881 - Infections and infestations 10061603 Respiratory syncytial virus infection PT
    21.1 10021881 - Infections and infestations 10052200 Respiratory syncytial virus infection NOS LLT
    21.1 10021881 - Infections and infestations 10067384 Respiratory syncytial virus pneumonitis LLT
    21.1 10021881 - Infections and infestations 10069811 Respiratory syncytial virus bronchitis PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Female
    Trial protocol: ES (Prematurely Ended)
    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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