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Clinical trials for Shigella sonnei

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   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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    2 result(s) found for: Shigella sonnei. Displaying page 1 of 1.
    EudraCT Number: 2023-000945-18 Sponsor Protocol Number: 219449 Start Date*: 2024-10-28
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A Phase 2 single-blind, randomized, controlled, single center study to assess the immunogenicity and safety of a 2-dose schedule with GVGH altSonflex1-2-3 vaccine in African infants (H06_02TP)
    Medical condition: Prophylaxis for Shigellosis induced by Shigella sonnei, Shigella flexneri 1b, Shigella flexneri 2a and Shigella flexneri 3a.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10040550 Shigella infections HLT
    27.1 10021881 - Infections and infestations 10054178 Shigella infection PT
    20.0 10021881 - Infections and infestations 10040542 Shigella LLT
    20.0 10021881 - Infections and infestations 10040547 Shigella flexneri LLT
    20.0 10021881 - Infections and infestations 10040551 Shigella sonnei LLT
    20.1 10021881 - Infections and infestations 10004016 Bacterial diarrhoea PT
    20.0 10017947 - Gastrointestinal disorders 10012735 Diarrhoea PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2021-000891-12 Sponsor Protocol Number: 212149 Start Date*: 2021-10-05
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A staged Phase I/II observer-blind, randomised, controlled, multi-country study to evaluate the safety, reactogenicity, and immune responses to the GVGH altSonflex1-2-3 vaccine against S. sonnei an...
    Medical condition: Prophylaxis for Shigellosis induced by Shigella sonnei, Shigella flexneri 1b, Shigella flexneri 2a and Shigella flexneri 3a.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10040550 Shigella infections HLT
    20.0 10021881 - Infections and infestations 10054178 Shigella infection PT
    20.0 10021881 - Infections and infestations 10040542 Shigella LLT
    20.0 10021881 - Infections and infestations 10040547 Shigella flexneri LLT
    20.0 10021881 - Infections and infestations 10040551 Shigella sonnei LLT
    20.1 10021881 - Infections and infestations 10004016 Bacterial diarrhoea PT
    20.0 10017947 - Gastrointestinal disorders 10012735 Diarrhoea PT
    Population Age: Infants and toddlers, Children, Under 18, Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: (No results available)
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    Query did not match any studies.
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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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