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Clinical trials for 2023-000945-18

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    The EU Clinical Trials Register currently displays   44364   clinical trials with a EudraCT protocol, of which   7388   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).

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    1 result(s) found for: 2023-000945-18. 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)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021.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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