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Clinical trials for Norovirus

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   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).

    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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    7 result(s) found for: Norovirus. Displaying page 1 of 1.
    EudraCT Number: 2013-001419-64 Sponsor Protocol Number: NOR-107 Start Date*: 2014-01-24
    Sponsor Name:Takeda Vaccines (Montana), Inc.
    Full Title: A Phase II, Randomized, Controlled, Double-Blind, Dosage and Adjuvant Justification, Safety and Immunogenicity Trial of Intramuscular Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine Adjuv...
    Medical condition: Prevention of gastroenteritis caused by norovirus
    Disease: Version SOC Term Classification Code Term Level
    16.1 10021881 - Infections and infestations 10068189 Gastroenteritis norovirus PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2016-004288-37 Sponsor Protocol Number: NOR-213 Start Date*: 2017-03-15
    Sponsor Name:Takeda Vaccines, Inc.
    Full Title: A Phase 2, Long-Term Immunogenicity Follow-up Trial of Adult and Elderly Subjects who have Previously Received an Intramuscular Injection of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine
    Medical condition: Long-Term Immunogenicity Follow-up Trial of adult and Elderly Subjects who have Previously Received an Intramuscular Injection of Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000022894 10062371 Active immunization LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2014-000778-20 Sponsor Protocol Number: NOR-202 Start Date*: 2014-07-04
    Sponsor Name:Takeda Vaccines, Inc.
    Full Title: A Phase II, Randomized, Double-Blind, Dosage, Safety and Immunogenicity Trial of Intramuscular Norovirus GI.1/GII.4 Bivalent Virus-Like Particle Vaccine combined with Aluminum Hydroxide adjuvant in...
    Medical condition: Prevention of gastroenteritis caused by norovirus
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10068189 Gastroenteritis norovirus PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-005700-15 Sponsor Protocol Number: marha1983 Start Date*: 2013-01-07
    Sponsor Name:Lennart Svensson Linköping University Medical Faculty
    Full Title: Can 5-HT3 receptor antagonists be used to limit vomiting in rota- and norovirus infections?
    Medical condition: Virus caused vomiting and effect of the antiemetic drug Ondansetron
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-018624-20 Sponsor Protocol Number: OPM-CIC-G-H-0902 Start Date*: 2010-05-19
    Sponsor Name:University Medical Center Freiburg
    Full Title: Tolerance of virucidal alcohol-based hand rubs - healthy volunteer trial
    Medical condition: Only healthy volunteers are included in this trial. Alcohol-based hand rubs are licensed drugs in Germany. They are indicated to perform hand disinfection by health care workers and are used within...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2016-003444-37 Sponsor Protocol Number: ENTERR06929 Start Date*: 2016-08-26
    Sponsor Name:Sanofi
    Full Title: Bacillus clausii in the treatment of acute community–acquired diarrhea among Latin American children (cadiLAc)
    Medical condition: Diarrhea
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004856 10000706 Acute diarrhea LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2019-005008-16 Sponsor Protocol Number: STOPPIT-01 Start Date*: 2021-03-08
    Sponsor Name:University Medical Center Hamburg-Eppendorf
    Full Title: Stop of proton-pump inhibitor treatment in patients with liver cirrhosis – a double-blind, placebo-controlled trial
    Medical condition: Liver cirrhosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10019805 - Hepatobiliary disorders 10019641 Hepatic cirrhosis PT
    20.0 10019805 - Hepatobiliary disorders 10024667 Liver cirrhosis LLT
    20.0 10017947 - Gastrointestinal disorders 10003445 Ascites PT
    20.1 10021881 - Infections and infestations 10051156 Ascites infection LLT
    20.0 10021881 - Infections and infestations 10068547 Bacterascites PT
    20.0 10021881 - Infections and infestations 10068555 Monomicrobial non-neutrocytic bacterascites LLT
    24.1 10021881 - Infections and infestations 10061135 Spontaneous bacterial peritonitis PT
    21.1 10029205 - Nervous system disorders 10019660 Hepatic encephalopathy PT
    20.0 100000004866 10036201 Portal hypertensions HLT
    20.1 10019805 - Hepatobiliary disorders 10036200 Portal hypertension PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    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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