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Clinical trials for Virus Diseases AND Influenza Virus AND adjuvanted A(H1N1) influenza 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   44394   clinical trials with a EudraCT protocol, of which   7406   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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    20 result(s) found for: Virus Diseases AND Influenza Virus AND adjuvanted A(H1N1) influenza vaccine. Displaying page 1 of 1.
    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: 2019-001974-27 Sponsor Protocol Number: STOPFLU Start Date*: 2019-10-15
    Sponsor Name:Centre Hospitalier Universitaire Vaudois (CHUV)
    Full Title: Reducing the Burden of Influenza after Solid-Organ Transplantation: the STOP-FLU trial [Swiss Trial in solid Organ transplantation on Prevention of inFLUenza]
    Medical condition: Influenza in solid organ transplant patients
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10022000 Influenza PT
    21.1 10042613 - Surgical and medical procedures 10061890 Organ transplant PT
    21.1 10042613 - Surgical and medical procedures 10059429 Influenza immunisation PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    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
    EudraCT Number: 2011-003314-16 Sponsor Protocol Number: FLUVALAB-H-15 Start Date*: 2011-08-30
    Sponsor Name:Omninvest Ltd.
    Full Title: A Randomized, Active Controlled, Double-blind, Multi-Centre Study to Evaluate Safety and Immunogenicity of One Dose of FLUVAL AB-like (Trivalent, Whole Virus, Aluminium Phosphate Gel Adjuvanted) In...
    Medical condition: Immunization of healthy people against influenza virus infection
    Disease: Version SOC Term Classification Code Term Level
    14.0 10042613 - Surgical and medical procedures 10059430 Influenza immunization LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed)
    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: 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: 2011-003512-23 Sponsor Protocol Number: 114495 Start Date*: 2015-06-03
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase II, randomized, observer blind, multicenter study to evaluate the safety and immunogenicity of a single low dose of AS03-adjuvanted, Quebec- or Dresden- manufactured monovalent A/California...
    Medical condition: Healthy volunteers (immunization against A/California/7/2009 (H1N1)v-like influenza)
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004862 10073988 Bird flu LLT
    18.0 100000004865 10021433 Immunization LLT
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-003166-32 Sponsor Protocol Number: FLUVALAB-H-14 Start Date*: 2011-08-30
    Sponsor Name:Omninvest Ltd.
    Full Title: A Randomized, Double-blind, Multi-Center Study to Evaluate Safety and Immunogenicity of One Dose of Four FLUVAL AB-like (Trivalent, Whole Virus, Aluminium Phosphate Gel Adjuvanted) Influenza Vaccin...
    Medical condition: Immunization of healthy people against influenza virus infection
    Disease: Version SOC Term Classification Code Term Level
    14.0 10042613 - Surgical and medical procedures 10059430 Influenza immunization LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed)
    Trial results: View results
    EudraCT Number: 2021-001721-40 Sponsor Protocol Number: V118_23 Start Date*: 2021-10-29
    Sponsor Name:Seqirus UK Limited
    Full Title: A Phase 3, Randomized, Observer-blind, Controlled, Multicenter, Clinical Study to Evaluate Immunogenicity and Safety of an MF59-adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine in Comp...
    Medical condition: Prophylaxis of Influenza
    Disease: Version SOC Term Classification Code Term Level
    20.0 10021881 - Infections and infestations 10022000 Influenza PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) EE (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
    EudraCT Number: 2010-020312-12 Sponsor Protocol Number: 114294 Start Date*: 2010-09-16
    Sponsor Name:GlaxoSmithKline S.A.
    Full Title: Estudio fase IIa, observador-ciego, multinacional, multicéntrico, aleatorizado para evaluar la inmunogenicidad, seguridad y reactogenicidad de la vacuna antigripal tetravalente (QIV) adyuvada con d...
    Medical condition: Vacunación frente a la gripe A y B de niños sanos, de 6 a 35 meses de edad, que no hayan recibido ninguna vacunación frente a la gripe (estacional y pandémica).
    Disease: Version SOC Term Classification Code Term Level
    12.1 10022000 Influenza LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) FI (Prematurely Ended)
    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: 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: 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: 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: 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: 2014-005075-88 Sponsor Protocol Number: V110_08 Start Date*: 2014-12-15
    Sponsor Name:Novartis Pharma K.K
    Full Title: A Multi-center, Randomized, Single-blind, Dose-Ranging Study to Evaluate Immunogenicity, Safety and Tolerability of Different Doses of Adjuvanted Cell-Derived, Inactivated Novel Swine Origin A/H1N1...
    Medical condition: Prophylaxis of A (H1N1) 2009 Swine Origin Pandemic Influenza
    Disease:
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2009-013105-34 Sponsor Protocol Number: 810706 Start Date*: 2009-11-09
    Sponsor Name:Baxter Innovations GmbH
    Full Title: A PHASE I/II STUDY TO ASSESS THE SAFETY AND IMMUNOGENICITY OF A VERO CELL-DERIVED WHOLE VIRUS H5N1 INFLUENZA VACCINE IN HEALTHY INFANTS, CHILDREN AND ADOLESCENTS AGED 6 MONTHS TO 17 YEARS
    Medical condition: Prophylaxis of influenza infection caused by a pandemic influenza virus (H5N1)
    Disease: Version SOC Term Classification Code Term Level
    13.1 10042613 - Surgical and medical procedures 10059430 Influenza immunization LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed) ES (Completed) 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: 2022-000623-21 Sponsor Protocol Number: 218350 Start Date*: 2022-09-21
    Sponsor Name:GlaxoSmithKline, S.A.
    Full Title: A Phase III, open-label, randomized, controlled, multi-country study to evaluate the immune response, safety and reactogenicity of an RSVPreF3 OA investigational vaccine when co-administered with F...
    Medical condition: Respiratory syncytial virus infection
    Disease:
    Population Age: Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) BE (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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