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Clinical trials for AS03 Adjuvant

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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    10 result(s) found for: AS03 Adjuvant. Displaying page 1 of 1.
    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: 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: 2006-000939-97 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: 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: 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: 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: 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: View results
    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
    EudraCT Number: 2009-016268-35 Sponsor Protocol Number: 113883 Start Date*: 2009-12-09
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase II, randomized, observer blind study to evaluate the safety and immunogenicity of three different vaccination schedules employing two formulations of the monovalent A/California/7/2009 (H1N...
    Medical condition: Immunization of healthy children aged 10 to less than 18 years against A/California/7/2009 (H1N1)v-like influenza
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SK (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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