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Clinical trials for H5N1 Virus AND H5N1 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   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    28 result(s) found for: H5N1 Virus AND H5N1 Vaccine. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2015-003458-42 Sponsor Protocol Number: 116938 Start Date*: 2016-06-27
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase II observer-blind, multicentre, dose-ranging study of children 6 to less than 36 months of age who are to be primed with a 2-dose series of GSK Biologicals’ AS03-adjuvanted A/Indonesia/05/2...
    Medical condition: Healthy volunteers (Active immunization against influenza A virus H5N1 subtype).
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: PL (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2006-005203-33 Sponsor Protocol Number: V87P3 Start Date*: 2006-11-16
    Sponsor Name:Novartis Vaccines and Diagnostics GmbH & Co. KG
    Full Title: A Phase II, Multicenter, Exploratory Study to Evaluate Safety and Immunogenicity of Two Doses of FLUAD-H5N1 Influenza Vaccine in Adults Unprimed and Primed with MF59-adjuvanted or Non-adjuvanted H5...
    Medical condition: avian influenza
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2011-004734-33 Sponsor Protocol Number: 109825 Start Date*: 2012-04-12
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A Phase II, non-randomised, open-label study to evaluate the safety and immunogenicity of the adjuvanted (pre-) pandemic H5N1 influenza candidate vaccine following a heterologous prime-boost schedu...
    Medical condition: Immunisation of healthy children aged 6 to 35 months against H5N1 influenza.
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2005-004153-10 Sponsor Protocol Number: H5N1/2005/01 Start Date*: 2005-09-22
    Sponsor Name:OTH - Chief Medical Officer's Office
    Full Title: Safety and immunogenecity of NIBRG-14 H5N1 01-2005 mock-up vaccine for potencial pandemic vaccine producers in Hungary
    Medical condition: Immunization of healthy people against influenza H5N1 infection
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-001898-32 Sponsor Protocol Number: V87_30 Start Date*: Information not available in EudraCT
    Sponsor Name:Seqirus UK Limited
    Full Title: A Phase 2, Randomized, Observer-Blind, Multicenter Study to Evaluate the Immunogenicity and Safety of Several Doses of Antigen and MF59 Adjuvant Content in a Monovalent H5N1 Pandemic Influenza Vacc...
    Medical condition: Prophylaxis for Influenza virus
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10022000 Influenza PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: EE (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-004751-39 Sponsor Protocol Number: 115115 Start Date*: 2012-04-12
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III, randomized, open, active-controlled study to evaluate the safety and immunogenicity of a prime-boost schedule of the H5N1 candidate vaccine adjuvanted with AS03B administered to childr...
    Medical condition: Prime-boost immunisation of healthy subjects aged 3 to 17 years against pandemic H5N1 influenza.
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2006-006307-37 Sponsor Protocol Number: 810601 Start Date*: 2007-05-15
    Sponsor Name:Baxter Innovations GmbH
    Full Title: AN OPEN LABEL PHASE III STUDY OF A VERO CELL-DERIVED WHOLE VIRUS H5N1 INFLUENZA VACCINE TO ASSESS THE IMMUNOGENICITY AND SAFETY AND TO INVESTIGATE THE NEED FOR AND TIMING OF A BOOSTER VACCINATION
    Medical condition: H5N1 Influenza vaccination in healthy subjects
    Disease: Version SOC Term Classification Code Term Level
    9.1 10022000 Influenza LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2006-001168-22 Sponsor Protocol Number: 107066 , 108498, 108500 Start Date*: 2007-06-08
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase II, randomized, open, partially controlled study to evaluate the safety and immunogenicity of different formulations of a pandemic influenza vaccine candidate (split virus formulation adjuv...
    Medical condition: Immunization of healthy children aged 3-9 years against (H5N1) influenza.
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2008-000558-11 Sponsor Protocol Number: 810705 Start Date*: 2008-06-26
    Sponsor Name:Baxter Innovations GmbH
    Full Title: An Open-Label Phase III Study to Assess the Safety and Immunogenicity of a Vero Cell-Derived Whole Virus H5N1 Influenza Vaccine in an Adult and Elderly Population as well as in Specified Risk Groups
    Medical condition: H5N1 vaccination in healthy subjects (adult and elderly population) and in specified risk groups (chronically ill, transplant and HIV patients).
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) DE (Completed) LV (Completed) FI (Completed) LT (Completed) NL (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2015-001979-46 Sponsor Protocol Number: BVX-007 Start Date*: 2015-09-24
    Sponsor Name:BiondVax Pharmaceuticals ltd
    Full Title: A multicenter, randomized, double-blind, active-controlled phase IIb trial as part of the EU-funded UNISEC project to assess the immunogenicity and safety of a BiondVax-developed influenza vaccine ...
    Medical condition: vaccine against influenza
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004865 10016794 Flu vaccination LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: HU (Completed)
    Trial results: View results
    EudraCT Number: 2007-002894-30 Sponsor Protocol Number: 810703 Start Date*: 2007-09-27
    Sponsor Name:Baxter AG
    Full Title: AN OPEN-LABEL PHASE II STUDY TO ASSESS THE IMMUNOGENICITY AND SAFETY OF A BOOSTER VACCINATION WITH A HETEROLOGOUS VERO CELL-DERIVED WHOLE VIRUS H5N1 INFLUENZA VACCINE IN A HEALTHY YOUNG ADULT POPUL...
    Medical condition: Prophylaxis of H5N1 influenza infection in an officially declared pandemic situation. Pandemic influenza vaccine should be used in accordance with official guidance
    Disease: Version SOC Term Classification Code Term Level
    9.1 10022000 Influenza LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2008-003871-32 Sponsor Protocol Number: V87P13 Start Date*: 2008-10-01
    Sponsor Name:Novartis Vaccines and Diagnostics S.r.l.
    Full Title: A Phase III, Randomized, Controlled, Observer-Blind, Multicenter Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Doses of a Monovalent A/H5N1 Influenza Vaccine Adjuvanted with ...
    Medical condition: pandemic influenza
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FI (Completed)
    Trial results: View results
    EudraCT Number: 2006-004041-42 Sponsor Protocol Number: 108251, 108252, 111275, 111276 Start Date*: 2006-11-17
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase II, randomised, open study to evaluate the immunogenicity and safety of a single or double-dose of the pandemic influenza candidate vaccine (split virus formulation adjuvanted with AS03) gi...
    Medical condition: Immunization against influenza disease during pandemic in subjects over 60 years of age.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-001683-29 Sponsor Protocol Number: 114464 Start Date*: 2015-06-03
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A Phase 2/3, randomized, controlled, observer-blind, multi-center trial to evaluate the safety and immunogenicity of a two-dose primary vaccination series of monovalent A/Indonesia/5/2005 (H5N1) va...
    Medical condition: Healthy volunteers (immunization against avian influenza virus A (H5N1) infection)
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004862 10073988 Bird flu LLT
    18.0 100000004865 10021433 Immunization LLT
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2008-005133-30 Sponsor Protocol Number: 810802 Start Date*: 2009-01-22
    Sponsor Name:Baxter Innovations GmbH
    Full Title: An Open Label Phase I/II Study to Assess the Immunogenicity and Safety of a Single Prime-Boost Vaccination Schedule with a Vero Cell-Derived Whole Virus H5N1 Influenza Vaccine in Healthy volunteers...
    Medical condition: H5N1 vaccination with a single Prime-Boost Vaccination schedule in healthy subjects aged 18 to 59 years.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10059430 Influenza immunization LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Completed) FI (Completed)
    Trial results: View results
    EudraCT Number: 2010-019835-37 Sponsor Protocol Number: GPF15 Start Date*: 2010-06-29
    Sponsor Name:Sanofi Pasteur SA
    Full Title: Safety and Immunogenicity of an Intramuscular H5N1 Inactivated, Split Virion Influenza Vaccine Adjuvanted with AF03 in Adults and Elderly subjects
    Medical condition: Preventive vaccination study in healthy subjects aged 18-60 years and over 60 years against infection with H5N1 Influenza Virus A/Indonesia/5/05-RG2 (H5N1)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) FR (Completed) GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2006-005428-18 Sponsor Protocol Number: V87P4 Start Date*: 2007-01-19
    Sponsor Name:Novartis Vaccines and Diagnostics GmbH & Co. KG
    Full Title: A Phase III, Randomized, Controlled, Observer-Blind, Multicenter Study to Evaluate the Immunogenicity, Safety and Tolerability of Two Doses of FLUAD-H5N1 Influenza Vaccine in Adult and Elderly Subj...
    Medical condition: avian influenza
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LT (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2007-002712-25 Sponsor Protocol Number: V101P1 Start Date*: 2007-10-29
    Sponsor Name:Novartis Vaccines and Diagnostics GmbH & Co. KG
    Full Title: A Phase II, Randomized, Placebo-controlled, Observer-blind, Multi Center Study on the Safety and Immunogenicity of Novartis Tetravalent Influenza Vaccine (containing both interpandemic strains and ...
    Medical condition: Avian Influenza
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2021-004813-37 Sponsor Protocol Number: V89_11 Start Date*: 2022-04-14
    Sponsor Name:Seqirus Inc. formerly Novartis Vaccines and Diagnostics Inc.
    Full Title: A Phase II, Randomized, Observer-Blind, Multi-Center, Study to Evaluate Safety, Tolerability and Immunogenicity of an Adjuvanted Cell Culture-Derived H5N1 Subunit Influenza Virus Vaccine at Two Dif...
    Medical condition: Prophylaxis for Influenza virus
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10022000 Influenza PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2006-001281-16 Sponsor Protocol Number: 107064, 107217 Start Date*: 2006-05-16
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III, observer-blind, randomised study to evaluate the safety and immunogenicity of one and two administrations of pandemic monovalent (H5N1) influenza vaccine (split virus formulation conta...
    Medical condition: Immunization against (H5N1) influenza disease in subjects aged 18 years and older.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) DE (Completed) ES (Completed) EE (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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