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Clinical trials for Rotaviral gastroenteritis

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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    8 result(s) found for: Rotaviral gastroenteritis. Displaying page 1 of 1.
    EudraCT Number: 2017-000264-15 Sponsor Protocol Number: V260-029 Start Date*: 2017-03-07
    Sponsor Name:Banyu Pharmaceutical Co., Ltd. a subsidiary of Merck & Co.,Inc, Kenilworth, New Jersey, USA
    Full Title: A phase III randomized, placebo-controlled clinical trial to study the efficacy and safety of V260 in healthy infants in Japan
    Medical condition: Prevention of Rotavirus Gastroenteritis Caused by Serotypes G1, G2, G3, G4, and G-Serotypes Associated With P1A [8] (e.g., G9) in Infants
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004862 10039232 Rotavirus gastroenteritis LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2005-003508-12 Sponsor Protocol Number: 010-01 Start Date*: 2006-02-28
    Sponsor Name:Merck and Co., Inc.
    Full Title: Safety and Immunogenicity of Concomitant Use of RotaTeq™ and INFANRIX™ Hexa in Healthy Children
    Medical condition: RotaTeq is an oral pentavalent vaccine indicated for the prevention of rotavirus gastroenteritis in infants and children caused by the serotypes G1, G2, G3, G4, and G-serotypes that contain P1 (e.g...
    Disease: Version SOC Term Classification Code Term Level
    10 10017913 LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2017-000263-32 Sponsor Protocol Number: V260-028 Start Date*: 2017-03-07
    Sponsor Name:Merck & Co., Inc.
    Full Title: A Double-Blind, Randomized, Placebo-Controlled, Safety and Tolerability Study of Live Pentavalent Human-Bovine Rotavirus Reassortant Vaccine in Chinese Healthy Adults, Children and Infants
    Medical condition: Prevention of Rotavirus Gastroenteritis Caused by Serotypes G1, G2, G3, G4, and G-Serotypes Associated With P1A [8] (e.g., G9) in Infants
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004862 10039232 Rotavirus gastroenteritis LLT
    Population Age: Infants and toddlers, Children, Under 18, Adults 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
    EudraCT Number: 2017-000277-37 Sponsor Protocol Number: V260-060 Start Date*: 2017-03-10
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: Post-marketing, Randomized, Open-label Study to Assess the Immunogenicity and Safety of Concomitant Administration of V260 and Diphtheria, Tetanus, Pertussis and Inactivated Poliovirus Vaccine (DTP...
    Medical condition: Prevention of Rotavirus Gastroenteritis Caused by Serotypes G1, G2, G3, G4, and G-Serotypes Associated With P1A [8] (e.g., G9) in Infants
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004862 10039232 Rotavirus gastroenteritis LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2012-001611-23 Sponsor Protocol Number: V260-035 Start Date*: 2012-09-28
    Sponsor Name:Merck Sharp & Dohme Corp., una filial de Merck & Co., Inc.
    Full Title: A Double-Blind, Randomized, COntrolled, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of a New Formulation of RotaTeq(TM)
    Medical condition: Prevention of rotavirus gastroenteritis in infants and children caused by serotypes G1, G2, G3, G4, and G serotypes that contain P1A[8] (e.g., G9)
    Disease: Version SOC Term Classification Code Term Level
    14.1 10021881 - Infections and infestations 10039232 Rotavirus gastroenteritis LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed) SE (Completed) FI (Completed) CZ (Completed) PL (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2004-001175-19 Sponsor Protocol Number: 102247 Start Date*: 2004-08-24
    Sponsor Name:GlaxoSmithKline
    Full Title: A phase IIIb, double-blind, randomized, placebo-controlled, multi-country and multi-center study to assess the efficacy, safety and immunogenicity of two doses of GSK Biologicals’ oral live attenua...
    Medical condition: Two-dose immunization according to 0, 1 or 2-month schedule against rotavirus disease in healthy infants aged 6 to 14 weeks at the time of the first dose. Rotavirus infection.
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed) CZ (Completed) IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2006-003762-33 Sponsor Protocol Number: 106481 Start Date*: 2006-12-06
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase IIIb, double blind, randomised, placebo–controlled, multi–country, multicentre study to assess the safety, reactogenicity and immunogenicity of two doses of GlaxoSmithKline (GSK) Biological...
    Medical condition: Primary immunisation of pre–term infants against human rotavirus gastroenteritis (GE)
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed) PT (Completed) 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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