Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Rotavirus vaccine

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   44300   clinical trials with a EudraCT protocol, of which   7354   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.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    68 result(s) found for: Rotavirus vaccine. Displaying page 1 of 4.
    1  2  3  4  Next»
    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: 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: 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: 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: 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: 2016-005159-25 Sponsor Protocol Number: V260-024-01 Start Date*: 2016-12-16
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy, Safety, and Immunogenicity of V260 in Healthy Chinese Infants
    Medical condition: Prevention of rotavirus gastroenteritis
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-004252-60 Sponsor Protocol Number: RTQ-15-TKU Start Date*: 2014-12-16
    Sponsor Name:Vaccine Research Center, University of Tampere
    Full Title: Shedding and immune response of rotavirus vaccine (RotaTeq)
    Medical condition: Test subjects are healthy.
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-003731-63 Sponsor Protocol Number: 114351 Start Date*: 2015-05-13
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase IV, open, multi-centre study to assess the immunogenicity, reactogenicity and safety of two doses of GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine in healthy Taiwanese...
    Medical condition: Healthy volunteers (Two-dose primary vaccination at 2 and 4 months of age in healthy infants previously unin-fected with HRV infection)
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2006-005445-11 Sponsor Protocol Number: S06-ROT-304 Start Date*: 2006-12-13
    Sponsor Name:Sanofi Pasteur MSD S.N.C.
    Full Title: An open-label, randomised, comparative, multi-centre study of the immunogenicity and safety of the concomitant use of a live pentavalent rotavirus vaccine (RotaTeq®) and a meningococcal group C con...
    Medical condition: RotaTeq® is indicated for the active immunisation of infants from age of 6 weeks for prevention of gastroenteritis due to rotavirus infection. NeisVac-C® is indicated for active immunisation of ch...
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: View results
    EudraCT Number: 2012-001875-35 Sponsor Protocol Number: 116566 Start Date*: 2019-04-17
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III, randomized, open study to assess the immunogenicity, reactogenicity and safety of two different formulations of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated human rotavirus ...
    Medical condition: Healthy volunteers [Active immunization of infants against gastroenteritis (GE) due to rotavirus (RV)].
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2012-004039-21 Sponsor Protocol Number: 103366 Start Date*: 2015-05-20
    Sponsor Name:GlaxoSmithKline
    Full Title: An open, multicentric, post-marketing surveillance study to evaluate the safety and reactogenicity of GlaxoSmithKline Biologicals’ live attenuated oral Human Rotavirus (HRV) vaccine, Rotarix when a...
    Medical condition: Healthy volunteers (Rotarix is indicated for the prevention of gastro-enteritis caused by Rotavirus, G1 and non G1 serotypes (such as G2, G3, G4, G9))
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    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: 2012-001481-16 Sponsor Protocol Number: 113518 Start Date*: 2015-05-13
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase I, double-blind, randomised, placebo-controlled study to assess the reactogenicity and safety of two doses of GlaxoSmithKline Biologicals’ (GSK) oral live attenuated liquid human rotavirus ...
    Medical condition: Healthy volunteers (Active immunisation of infants against gastroenteritis (GE) due to rotavirus (RV))
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-001542-29 Sponsor Protocol Number: 106260 Start Date*: 2015-06-22
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase IIIb, randomized, double-blind, placebo-controlled study to explore the existence of horizontal transmission of the RIX4414 vaccine strain between twins within a family.
    Medical condition: Rotavirus (RV) gastroenteritis
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2015-001546-28 Sponsor Protocol Number: 111664 Start Date*: 2015-06-11
    Sponsor Name:Smithkline Beecham Pvt Limited
    Full Title: Open, multi-centric, post-marketing surveillance (PMS) to evaluate the reactogenicity and safety of two doses of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated human rotavirus (HRV) vaccin...
    Medical condition: Rotavirus Gastroenteritis
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2006-003239-61 Sponsor Protocol Number: 107876 Start Date*: 2006-09-29
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III, randomised study to evaluate the clinical consistency in terms of immunogenicity and reactogenicity of three production lots of the liquid formulation of GlaxoSmithKline (GSK) Biologic...
    Medical condition: Two-dose immunisation at 3 and 4 months of age in healthy infants previously uninfected with HRV.
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: View results
    EudraCT Number: 2015-001543-36 Sponsor Protocol Number: 107625 Start Date*: 2015-06-22
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III, double-blind, randomised, placebo-controlled, multi-centre study in Japan to assess the efficacy, safety, reactogenicity and immunogenicity of the lyophilised formulation of GlaxoSmith...
    Medical condition: Healthy volunteers
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2020-003329-49 Sponsor Protocol Number: V260-074 Start Date*: 2021-08-16
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase 3 Randomized, Open-Label, Clinical Trial to Study the Immunogenicity and Safety of Concomitant and Non-Concomitant Administration of V260 and Inactivated Poliomyelitis Vaccine (IPV) in Chin...
    Medical condition: Immunogenicity and safety assessment of concomitant administration of RotaTeq (V260) and IPV in Chinese healthy infants.
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004865 10076887 Rotavirus immunization LLT
    21.1 100000004865 10054187 Polio immunization LLT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-001508-37 Sponsor Protocol Number: 113681 Start Date*: 2015-05-22
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: Phase III randomized, open, controlled study to evaluate the immune response to the hepatitis B antigen of the RTS,S/AS01E candidate vaccine, when administered as primary vaccination integrated int...
    Medical condition: Healthy volunteers (Primary immunization against Plasmodium falciparum malaria, immunization against hepatitis B)
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    1  2  3  4  Next»
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA