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Clinical trials for Pandemrix

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   44335   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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    14 result(s) found for: Pandemrix. Displaying page 1 of 1.
    EudraCT Number: 2010-022817-24 Sponsor Protocol Number: OVG 2010/03 Start Date*: 2010-10-18
    Sponsor Name:University of Oxford
    Full Title: A multi-centre, open-label, clinical, phase 4 trial, following on from a head-to-head comparison study of two H1N1 influenza vaccines in children, to compare firstly, the persistence of antibody ag...
    Medical condition: Prevention of Influenza infections
    Disease: Version SOC Term Classification Code Term Level
    12.0 10059429 Influenza immunisation LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2010-020330-26 Sponsor Protocol Number: 114451 Start Date*: 2010-08-19
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase IV, open label, randomized, multicountry study to evaluate immunogenicity and safety of GSK Biologicals' seasonal (2010-2011) influenza vaccine FluarixTM in children previously vaccinated w...
    Medical condition: Immunization against influenza of children previously vaccinated with GSK's adjuvanted H1N1 vaccine (Pandemrix) at the age of 6 months - 9 years.
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: SE (Completed) NL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2010-020313-81 Sponsor Protocol Number: 114454 Start Date*: 2010-08-24
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A Phase IIIA, open, randomized study to assess immunogenicity and safety of Fluarix™/Influsplit SSW® 2010/2011 or Pandemrix™ vaccination in adults aged 18 years and above previously vaccinated with...
    Medical condition: Immunization against influenza in male and female adult subjects
    Disease: Version SOC Term Classification Code Term Level
    12.1 10022000 Influenza LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2010-023313-57 Sponsor Protocol Number: INF Start Date*: 2012-04-10
    Sponsor Name:Helsinki University Central Hospital
    Full Title: Homing potential of the antigen specific B cell and antibody mediated immune response after vaccination
    Medical condition: Basic healthy volunteers
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-015743-16 Sponsor Protocol Number: NA Start Date*: 2009-10-09
    Sponsor Name:University Hospitals of Leicester NHS Trust
    Full Title: A randomised, partially observer-blind, multi-centre, head-to-head comparison of a two dose regimen of Baxter and GSK H1N1 pandemic vaccines, administered 21 days apart
    Medical condition: Pandemic H1N1 influenza.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2010-021033-30 Sponsor Protocol Number: H1N1-495-10THL Start Date*: 2010-09-14
    Sponsor Name:National Institute for Health and Welfare
    Full Title: Evaluation of the effectiveness of vaccination with 2009 H1N1 vaccines during influenza season 2010-11 2009 H1N1-influenssarokotteiden tehokkuus influenssakaudella 2010-11
    Medical condition: Influenza caused by the 2009 H1N1 influenza virus ("swine influenza")
    Disease: Version SOC Term Classification Code Term Level
    12.1 10022001 Influenza (epidemic) LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: View results
    EudraCT Number: 2010-020331-39 Sponsor Protocol Number: 114452 Start Date*: 2010-09-14
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A Phase IV, open label, randomized, monocentric study to evaluate immunogenicity and safety of GSK Biologicals' seasonal (2010-2011) influenza vaccine FluarixTM in adolescents previously vaccinated...
    Medical condition: Immunization against influenza of children previously vaccinated with GSK's adjuvanted H1N1 vaccine (PandemrixTM) at the age of 10-17 years.
    Disease: Version SOC Term Classification Code Term Level
    12.1 10022000 Influenza LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: View results
    EudraCT Number: 2009-016789-10 Sponsor Protocol Number: 02-04-80 Start Date*: 2010-02-19
    Sponsor Name:Div KIR AMC
    Full Title: Efficacy of the H1N1 Flu (swine flu) vaccination in patients with Rheumatoid Arthritis treated with rituximab
    Medical condition: To assess the efficacy of A/H1N1 vaccination in patients treated with rituximab therapy
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-003592-35 Sponsor Protocol Number: LAIVImmuno Start Date*: 2014-04-07
    Sponsor Name:Public Health England
    Full Title: A phase III/IV open-label study of the immunogenicity and safety of a single dose of a Live Attenuated Influenza Vaccine (LAIV) (FluenzTM) for each of three successive years in children naïve to, o...
    Medical condition: Protection against influenza in healthy children
    Disease: Version SOC Term Classification Code Term Level
    14.1 10042613 - Surgical and medical procedures 10059430 Influenza immunization LLT
    14.1 10042613 - Surgical and medical procedures 10046859 Vaccination LLT
    14.1 10042613 - Surgical and medical procedures 10059429 Influenza immunisation PT
    14.1 10042613 - Surgical and medical procedures 10039244 Routine vaccination LLT
    14.1 10042613 - Surgical and medical procedures 10016794 Flu vaccination LLT
    Population Age: Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2009-015174-35 Sponsor Protocol Number: 113629 Start Date*: 2009-11-13
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase II, randomised, open-label study to evaluate the safety and immunogenicity of the adjuvanted pandemic H1N1 influenza candidate vaccine following a 0-28 day or 0-4 month vaccination schedule...
    Medical condition: Immunisation against A/California/7/2009 (H1N1)v-like influenza in male and female children aged 8 to 12 weeks.
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: NO (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-015700-26 Sponsor Protocol Number: AH1N1-483-09THL Start Date*: 2009-10-16
    Sponsor Name:National Institute for Health and Welfare
    Full Title: Evaluation of a vaccination campaign with A(H1N1)v pandemic vaccines: a prospective cohort study. A(H1N1)v-pandemiarokotuskampanjan vaikutukset
    Medical condition: Influenza caused by the new A(H1N1)v influenza virus ("swine influenza")
    Disease: Version SOC Term Classification Code Term Level
    12.0 10022001 Influenza (epidemic) LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: View results
    EudraCT Number: 2009-014719-11 Sponsor Protocol Number: 2009/08 H1N1 Start Date*: 2009-09-18
    Sponsor Name:University of Oxford
    Full Title: Open Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Baxter H1N1 vaccine and GlaxoSmithKline H1N1 vaccine in children 6 months to 12...
    Medical condition: Prophylaxis of influenza in an officially declared pandemic situation.
    Disease: Version SOC Term Classification Code Term Level
    12.0 10059429 Influenza immunisation LLT
    12.0 10059637 Influenza antibody test LLT
    12.0 10059642 Influenza antibody test positive LLT
    12.0 10059643 Influenza antibody test negative LLT
    12.0 10060063 Influenza serology LLT
    12.0 10060078 Influenza serology positive LLT
    12.0 10060079 Influenza serology negative LLT
    12.0 10022000 Influenza LLT
    12.0 10022002 Influenza A virus infection LLT
    12.0 10022001 Influenza (epidemic) LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (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: 2009-016226-13 Sponsor Protocol Number: ANRS 151 Start Date*: 2009-10-15
    Sponsor Name:Agence nationale de recherches sur le sida et les hépatites virales
    Full Title: Etude de phase II randomisée évaluant l'immunogénicité et la tolérance du vaccin antigrippal A(H1N1)v adjuvanté comparativement au vaccin antigrippal A(H1N1)v non adjuvanté chez des patients infect...
    Medical condition: infection VIH et vaccination anti-grippe A (H1N1)
    Disease: Version SOC Term Classification Code Term Level
    12.0 10016794 Flu vaccination LLT
    12.0 10020161 HIV infection LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (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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