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Clinical trials for MF59

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   44347   clinical trials with a EudraCT protocol, of which   7375   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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    18 result(s) found for: MF59. Displaying page 1 of 1.
    EudraCT Number: 2009-013671-21 Sponsor Protocol Number: V111_02 Start Date*: 2009-08-27
    Sponsor Name:Novartis Vaccines and Diagnostics S.r.l.
    Full Title: A Randomized, Single-blind, Dose-Ranging, Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of Adjuvanted and non Adjuvanted Egg-Derived, Inactivated Novel Swine O...
    Medical condition: Pandemic influenza
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) DE (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2008-002602-20 Sponsor Protocol Number: V104P2 Start Date*: 2008-09-30
    Sponsor Name:Novartis Vaccines and Diagnostics S.r.l.
    Full Title: A Phase Ib, Randomized, Observer-Blind, Multicenter, Factorial-Design Study to Evaluate the Safety, Tolerability and Immunogenicity of Two Injections of Trivalent Inactivated Influenza Vaccine with...
    Medical condition: seasonal influenza
    Disease: Version SOC Term Classification Code Term Level
    9.1 10022000 Influenza LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2014-005107-24 Sponsor Protocol Number: V112_06 Start Date*: 2014-12-04
    Sponsor Name:Novartis Vaccines and Diagnostics
    Full Title: Pivotal, Multicenter, Observer-Blind, Randomized Study of Influenza A (H1N1) 2009 Monovalent Subunit Vaccine With and Without Adjuvant in Children Ages 6 to <36 Months
    Medical condition: Prophylaxis of A (H1N1) 2009 Pandemic Influenza
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2009-013639-39 Sponsor Protocol Number: V110_03 Start Date*: 2009-07-29
    Sponsor Name:Novartis Vaccines and Diagnostics S.r.l.
    Full Title: A Randomized, Single-blind, Dose-Ranging, Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of Adjuvanted and non Adjuvanted Cell-Derived, Inactivated Novel Swine ...
    Medical condition: Pandemic influenza
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2009-013672-45 Sponsor Protocol Number: V111_03 Start Date*: 2009-08-27
    Sponsor Name:Novartis Vaccines and Diagnostics S.r.l.
    Full Title: A Randomized, Single-blind, Dose-Ranging Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted and non-Adjuvanted Egg-derived, Inactivated Novel Swine...
    Medical condition: Pandemic influenza
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Completed) DE (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2009-013640-37 Sponsor Protocol Number: V110_04 Start Date*: 2009-07-31
    Sponsor Name:Novartis Vaccines and Diagnostics S.r.l.
    Full Title: A Randomized, Single-blind, Dose-Ranging Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of Adjuvanted and non Adjuvanted Cell-derived, Inactivated Novel Swine O...
    Medical condition: Pandemic influenza
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) NL (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2009-012394-35 Sponsor Protocol Number: CCAD106A2203 Start Date*: 2010-03-24
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A 90-week, multi-center, randomized, double-blind, placebo-controlled study in patients with mild Alzheimer’s Disease (AD) to investigate the safety, tolerability and Abeta-specific antibody respon...
    Medical condition: Alzheimer's Disease.
    Disease: Version SOC Term Classification Code Term Level
    12.1 10001896 Alzheimer's disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) SE (Completed) ES (Completed) DE (Completed) BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2009-016877-14 Sponsor Protocol Number: H1N1-2009 Start Date*: 2009-11-04
    Sponsor Name:COPSAC
    Full Title: H1N1v Vaccination of Pregnant Women: A Longitudinal Cohort Study Characterizing Influenza A-H1N1v Vaccination in Pregnant Women
    Medical condition: Protection against Influenza A H1N1v disease
    Disease:
    Population Age: In utero, Preterm newborn infants, Newborns, Infants and toddlers, Under 18, Adults Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2012-002443-26 Sponsor Protocol Number: OVG2012/04 Start Date*: 2012-08-17
    Sponsor Name:University of Oxford
    Full Title: A phase II, multi-centre, open labelled randomised control trial to describe immune & transcriptomic responses to trivalent inactivated vaccine (TIV) & MF59 adjuvanted influenza vaccine (ATIV) in 1...
    Medical condition: Healthy children will be immunised with two vaccines against influenza: Agrippal or Imuvac, or Fluad to study the immune responses to immunisation at a genetic level.
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2015-001648-12 Sponsor Protocol Number: OVG2015/02 Start Date*: 2015-09-03
    Sponsor Name:University of Oxford
    Full Title: A phase II, open label trial to describe immune and transcriptional responses to MF59 adjuvanted trivalent influenza vaccine (ATIV) in 13-24 month healthy children and adults 18-65 years
    Medical condition: This trial is investigating healthy children and adult's gene expression and immune response to the Fluad (MF59)-adjuvanted trivalent influenza vaccine and also comparing these to the local and gen...
    Disease:
    Population Age: Infants and toddlers, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (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: 2014-005106-38 Sponsor Protocol Number: V112_02 Start Date*: 2014-12-04
    Sponsor Name:Novartis Vaccines and Diagnostics
    Full Title: A Pivotal Randomized, Single-Blind, Dose-Finding Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted and Non-Adjuvanted Egg-Derived, Inactivated Nov...
    Medical condition: Prophylaxis of A (H1N1) 2009 Pandemic Influenza
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-005185-30 Sponsor Protocol Number: V112_04 Start Date*: 2014-12-05
    Sponsor Name:Novartis Vaccines and Diagnostics
    Full Title: A Randomized, Open Label, Single Center, Dose- and Regimen-Ranging Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted and Non-Adjuvanted Egg-Derive...
    Medical condition: Prophylaxis of A(H1N1) 2009 Pandemic Influenza
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2014-002599-95 Sponsor Protocol Number: V118_05E1 Start Date*: 2014-09-19
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A Phase III, Randomized, Observer Blind, Multicenter Study to Evaluate the Safety and Immunogenicity of Repeated Exposure to an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV), Admin...
    Medical condition: Prophylaxis for influenza virus
    Disease: Version SOC Term Classification Code Term Level
    18.0 10021881 - Infections and infestations 10022000 Influenza PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: FI (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-000728-27 Sponsor Protocol Number: V118_18 Start Date*: 2015-09-30
    Sponsor Name:Seqirus UK Limited
    Full Title: A Phase III, Randomized, Observer-Blind, Controlled, Multicenter Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to ...
    Medical condition: Profylaxis for Influenza virus
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10022000 Influenza PT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: EE (Completed) PL (Completed) LV (Completed) CZ (Completed) LT (Completed) RO (Completed) BG (Completed)
    Trial results: View results
    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: 2015-002973-39 Sponsor Protocol Number: V118_05E3 Start Date*: 2015-09-01
    Sponsor Name:Seqirus UK Limited
    Full Title: A Phase III, Randomized, Observer Blind, Multicenter Study to Evaluate the Safety and Immunogenicity of Repeated Exposure to Either the Same or Alternate Type of Vaccine, Adjuvanted or Non-adjuvant...
    Medical condition: Prophylaxis for influenza virus
    Disease: Version SOC Term Classification Code Term Level
    19.0 10021881 - Infections and infestations 10022000 Influenza PT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: View results
    EudraCT Number: 2012-000218-12 Sponsor Protocol Number: V118_05 Start Date*: 2013-09-17
    Sponsor Name:Seqirus UK Limited
    Full Title: A Phase III, Stratified, Randomized, Observer Blind, Controlled, Multicenter Clinical Study to Evaluate the Safety, Immunogenicity and Efficacy of an Adjuvanted Quadrivalent Subunit Influenza Virus...
    Medical condition: Prophylaxis for influenza virus
    Disease: Version SOC Term Classification Code Term Level
    19.0 10021881 - Infections and infestations 10022000 Influenza PT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed) IT (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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