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Clinical trials for Oncogenic viruses

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   44338   clinical trials with a EudraCT protocol, of which   7368   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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    10 result(s) found for: Oncogenic viruses. Displaying page 1 of 1.
    EudraCT Number: 2009-017282-35 Sponsor Protocol Number: 113617 Start Date*: 2010-07-07
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase IIIb, open, multi-centre gynaecological extension study for the follow-up of a subset of HPV-015 study subjects
    Medical condition: GSK Biologicals' HPV-16/18 L1 VLP AS04 vaccine is indicated in females from 10 years of age onwards for the prevention of pre-malignant cervical lesions and cervical cancer causally related to Hum...
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: GB (Completed) NL (Completed) PT (Completed)
    Trial results: View results
    EudraCT Number: 2008-008124-33 Sponsor Protocol Number: 112024 Start Date*: 2009-10-07
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase IIIb, open, multi centre gynaecological extension study for follow-up of a subset of 580299/008 study subjects who were either cervical cytology negative and oncogenic HPV positive or pregn...
    Medical condition: GSK Biologicals’ HPV-16/18 L1 VLP AS04 vaccine is indicated in females from 10 years of age onwards for the prevention of cervical cancer (squamous-cell carcinoma and adenocarcinoma) by protecting ...
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: FI (Completed) ES (Completed) DE (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2005-002546-20 Sponsor Protocol Number: 104820 Start Date*: 2006-11-02
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III, double-blind, randomized, controlled study to evaluate the safety, immunogenicity and efficacy of GlaxoSmithKline Biologicals’ HPV 16/18 L1/AS04 vaccine administered intramuscularly ac...
    Medical condition: For active immunization of girls and women from 10 years of age onwards for the prevention of persistent human papillomavirus (HPV) infections and related clinical outcomes (cytological abnormaliti...
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: GB (Completed) PT (Completed)
    Trial results: View results
    EudraCT Number: 2007-001731-55 Sponsor Protocol Number: 106636 Start Date*: 2007-08-09
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III/IV, community-randomized, controlled study to evaluate the effectiveness of two vaccination strategies using GlaxoSmithKline Biologicals’ HPV-16/18 L1 VLP AS04 vaccine in reducing the p...
    Medical condition: For the prevention of high-grade cervical intraepithelial neoplasia (CIN grades 2 and 3) and cervical cancer causally related to human papillomavirus (HPV) types 16 and 18.
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004864 10008230 Cervix neoplasms malignant HLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: View results
    EudraCT Number: 2011-000757-22 Sponsor Protocol Number: 114700 Start Date*: 2011-06-28
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A Phase IIIb open-label, randomised, multi-centre primary immunization study to evaluate the immunogenicity and safety of GSK Biologicals’ HPV-16/18 L1 VLP AS04 vaccine when administered intramuscu...
    Medical condition: Cervarix is indicated in females from 10 years of age onwards for the prevention of persistent infection, premalignant cervical lesions and cervical cancer (squamous-cell carcinoma and adenocarcino...
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004862 10063001 Human papilloma virus infection LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Female
    Trial protocol: DE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2009-011357-41 Sponsor Protocol Number: 112772 Start Date*: 2009-07-01
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A long-term, open, follow-up of the immunogenicity and safety of GlaxoSmithKline Biologicals’ HPV-16/18 L1 VLP AS04 vaccine in healthy female subjects up to 10 years after administration of the fir...
    Medical condition: For active immunization of women from the age of 10 years onwards to prevent cervical cancer (squamous-cell carcinoma and adenocarcinoma) by protecting against incident and persistent infections, c...
    Disease: Version SOC Term Classification Code Term Level
    15.1 100000004862 10063001 Human papilloma virus infection LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DE (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2007-002777-32 Sponsor Protocol Number: 110659 Start Date*: 2007-10-23
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase I/II, partially blind, randomized, multicentre, age-stratified, dose-range study in healthy females aged 9 - 25 years to assess the safety and immunogenicity of GlaxoSmithKline Biologicals’...
    Medical condition: For active immunization of females for the prevention of cervical cancer by protecting against persistent infections, cytological abnormalities including atypical squamous cells of undetermined sig...
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004862 10063001 Human papilloma virus infection LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2013-003429-28 Sponsor Protocol Number: 109823 Start Date*: 2014-04-28
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase IV, observer-blind, randomized, controlled, multicentric study to assess the safety and immunogenicity of GSK Biologicals’ HPV-16/18 L1 VLP AS04 vaccine (Cervarix™) administered intramuscul...
    Medical condition: For active immunization of women from the age of 10 years onwards to prevent cervical cancer (squamous-cell carcinoma and adenocarcinoma) by protecting against incident and persistent infections, c...
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004865 10071147 Human papilloma virus immunization LLT
    19.0 100000004848 10058580 Human papilloma virus serology test LLT
    Population Age: Adolescents, Under 18, Adults Gender: Female
    Trial protocol: EE (Completed)
    Trial results: View results
    EudraCT Number: 2006-003807-38 Sponsor Protocol Number: 108464 Start Date*: 2007-01-30
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase IIIb, randomized, open, multicentre study to evaluate the immunogenicity and safety of GlaxoSmithKline Biologicals’ HPV-16/18 L1 AS04 vaccine co-administered with GlaxoSmithKline Biological...
    Medical condition: In female subjects from 10 years of age onwards for the prevention of cervical cancer by protecting against incident and persistent infections, cytological abnormalities including ASC-US, cervical ...
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Female
    Trial protocol: DE (Completed) FR (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2011-002035-26 Sponsor Protocol Number: 115411 Start Date*: 2011-10-21
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A Phase IIIb observer-blind, randomized, multicentre primary immunization study to evaluate the immunogenicity and safety of GSK Biologicals’ HPV-16/18 L1 VLP AS04 vaccine and Merck's Quadrivalent ...
    Medical condition: Cervarix is indicated in females from 10 years of age onwards for the prevention of persistent infection, premalignant cervical lesions and cervical cancer (squamous-cell carcinoma and adenocarcino...
    Disease: Version SOC Term Classification Code Term Level
    14.0 10021881 - Infections and infestations 10033723 Papilloma viral infection NOS LLT
    14.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10008229 Cervical cancer LLT
    14.0 10038604 - Reproductive system and breast disorders 10056576 Cervical intraepithelial neoplasia LLT
    Population Age: Children, Adolescents, Under 18 Gender: Female
    Trial protocol: FR (Completed) SE (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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