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Clinical trials for AS03

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   44258   clinical trials with a EudraCT protocol, of which   7344   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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    32 result(s) found for: AS03. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2007-003776-18 Sponsor Protocol Number: 110794 Start Date*: 2007-09-12
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase II, controlled, randomized, multicentre, single blind study to evaluate the immunogenicity, safety and reactogenicity of the low dose influenza vaccine with various doses of the AS03 adjuva...
    Medical condition: Immunisation of healthy male and female subjects aged 18-64 years against influenza
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2006-003769-15 Sponsor Protocol Number: 108656 Start Date*: 2006-09-06
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase II, controlled, randomized, single centre, single blind study to evaluate the immunogenicity, safety and reactogenicity of the low dose influenza vaccine with various doses of AS03 adjuvant...
    Medical condition: Immunization against influenza in male and female subjects aged 18-59 years old.
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2006-000939-97 Sponsor Protocol Number: 107022, 107191 Start Date*: 2006-04-25
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase IIb, controlled, randomised, multicenter, single blind study to demonstrate the Non-Inferiority of the low dose influenza vaccine with or without adjuvant AS03 compared with Fluarix™ (Glaxo...
    Medical condition: Immunization against influenza in male and female subjects aged 60 years and older
    Disease:
    Population Age: Elderly Gender: Male, Female
    Trial protocol: FI (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2006-001169-40 Sponsor Protocol Number: 107192, 107214 Start Date*: 2006-04-19
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase IIb, controlled, randomised, multicenter, observer blinded study to demonstrate the lot-to-lot consistency of three consecutive production lots of low dose of influenza vaccine adjuvanted w...
    Medical condition: Immunization against influenza in male and female subjects aged 60 years and older
    Disease:
    Population Age: Elderly Gender: Male, Female
    Trial protocol: GB (Completed) EE (Completed) DE (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2006-003815-31 Sponsor Protocol Number: 108708 Start Date*: 2006-10-05
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase IIb, controlled, randomized, multicenter, observer blinded study to evaluate the immunogenicity, safety and reactogenicity of a second vaccination with the low dose influenza vaccine adjuva...
    Medical condition: Re-vaccination against influenza in male and female subjects aged 60 years and older.
    Disease:
    Population Age: Elderly Gender: Male, Female
    Trial protocol: NO (Completed)
    Trial results: View results
    EudraCT Number: 2006-002680-18 Sponsor Protocol Number: 107975 Start Date*: 2006-08-03
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase II, controlled, randomized, single blind study to evaluate the immunogenicity, safety and reactogenicity of the low dose influenza vaccine adjuvanted with AS03 compared to Fluarix™ (GlaxoSm...
    Medical condition: Immunization against influenza in male and female subjects aged 60 years and older.
    Disease:
    Population Age: Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2007-002783-10 Sponsor Protocol Number: 110674 Start Date*: 2007-09-17
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase II, controlled, single centre, open study to evaluate the safety, reactogenicity and immunogenicity of a second vaccination with the low dose influenza vaccine adjuvanted with a reduced dos...
    Medical condition: Re-vaccination against influenza in male and female subjects aged 18-60 years old.
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2010-018392-22 Sponsor Protocol Number: 114182 Start Date*: 2010-03-24
    Sponsor Name:GlaxoSmithKline S.A.
    Full Title: Estudio fase I, abierto, multicéntrico para evaluar la seguridad e inmunogenicidad de la vacuna antigripal estacional trivalente (GSK2186877A) adyuvada con varias dosis de AS03, administrada en niñ...
    Medical condition: Vacunación frente a la gripe A y B de niños sanos, de 6 a 35 meses, que no hayan recibido la vacunación antigripal con anterioridad.
    Disease: Version SOC Term Classification Code Term Level
    12.1 10059430 Influenza immunization LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: ES (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: 2008-001303-34 Sponsor Protocol Number: 111295 Start Date*: 2008-06-25
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase I/II, randomized, single blind, controlled study in adults aged 18-60 years to evaluate the immunogenicity, safety and reactogenicity of an adjuvanted influenza vaccine candidate (GSK 21151...
    Medical condition: Immunization of healthy adults aged 18 to 60 years against influenza
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: CZ (Completed)
    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
    EudraCT Number: 2006-005477-22 Sponsor Protocol Number: 107495 Start Date*: 2007-01-22
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase II, open, randomized study in adults aged between 18 and 60 years designed to evaluate the reactogenicity and immunogenicity of a 1- and 2-dose prime-boost concept of pandemic monovalent (H...
    Medical condition: Immunization against influenza disease during pandemic in subjects aged 18 to 60 years.
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (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: 2007-000115-28 Sponsor Protocol Number: 109817 Start Date*: 2007-07-16
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase II, open, non-randomized study designed to evaluate the reactogenicity and immunogenicity of one or two booster administrations of an influenza pandemic candidate vaccine (GSK1562902A) in a...
    Medical condition: Since 1997, avian H5N1 influenza has caused several human infections and high mortality rate in Southeast Asia. Experts warn that the next influenza pandemic is imminent and could be severe. Preven...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2007-003802-86 Sponsor Protocol Number: 110847 Start Date*: 2007-10-05
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase II, observer-blind, multicountry, multicentre, randomized study to evaluate the immunogenicity, safety and reactogenicity of the GlaxoSmithKline Biologicals’ influenza vaccine adjuvanted wi...
    Medical condition: Immunization against influenza in male and female subjects aged 18-40 years old and 65 years and above.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) SE (Completed) NL (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2017-001584-20 Sponsor Protocol Number: 207543 Start Date*: 2017-10-02
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A Phase I/II, randomized, controlled, observer-blind, multi-center study to assess the reactogenicity, safety and immunogenicity of three GlaxoSmithKline (GSK) Biologicals’ investigational supra-se...
    Medical condition: Healthy volunteers (active immunization for the prevention of disease caused by influenza virus)
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (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: 2020-003370-41 Sponsor Protocol Number: VAT00002 Start Date*: 2021-08-23
    Sponsor Name:Sanofi Pasteur Inc.
    Full Title: Immunogenicity and Safety of SARS-CoV-2 Recombinant Protein Vaccines with AS03 Adjuvant in Adults 18 Years of Age and Older as a Primary Series and Immunogenicity and Safety of a Booster Dose of SA...
    Medical condition: COVID-19
    Disease: Version SOC Term Classification Code Term Level
    23.0 10021881 - Infections and infestations 10084268 COVID-19 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-013931-39 Sponsor Protocol Number: 113525 Start Date*: 2009-09-08
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase II, observer-blind, randomized study to assess the immunogenicity, safety and reactogenicity of a two-dose schedule with GSK Biologicals’ A/California/7/2009 (H1N1)v-like vaccine containing...
    Medical condition: Immunization against A/California/7/2009 (H1N1)v-like influenza and seasonal influenza (2009-2010) in male and female subjects aged 61 years and older.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: View results
    EudraCT Number: 2020-005090-26 Sponsor Protocol Number: Kleb4V01 Start Date*: 2021-06-21
    Sponsor Name:LimmaTech Biologics AG
    Full Title: Safety and immunogenicity of a Klebsiella pneumoniae tetravalent bioconjugate vaccine (Kleb4V) administered to healthy adults: A FTIH phase I/II randomized and controlled study.
    Medical condition: Klebsiella pneumoniae (K. pneumoniae), a gram negative Enterobacteriaceae, is an opportunistic pathogen leading to hospital- and community-acquired infections (urinary tract infections, pneumonia a...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004865 10046859 Vaccination LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (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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