Flag of the European Union EU Clinical Trials Register Help

Clinical trials for AS04

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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    27 result(s) found for: AS04. Displaying page 1 of 2.
    1  2  Next»
    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: 2007-003256-11 Sponsor Protocol Number: 109179 (HPV-044 PRI) Start Date*: 2007-10-02
    Sponsor Name:GLAXO SMITHKLINE
    Full Title: A phase IIIb open, randomized multi-center study to evaluate the immunogenicity and safety of GSK Biologicals HPV-16/18 L1 VLP AS04 vaccine when administered intramuscularly according to an alterna...
    Medical condition: For active immunization of females from the age of 10 years onwards to prevent incident and persistent infections, cytological abnormalities and cervical neoplasia (CIN), CIN 1 and pre-cancerous...
    Disease: Version SOC Term Classification Code Term Level
    6.1 10029109 HLT
    Population Age: Adolescents, Under 18, Adults Gender: Female
    Trial protocol: IT (Completed) SK (Completed)
    Trial results: View results
    EudraCT Number: 2010-020227-48 Sponsor Protocol Number: 113618 Start Date*: 2011-01-07
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase IIIb, open-label, multi-centre immunization study to evaluate the safety of GlaxoSmithKline (GSK) Biologicals’ HPV-16/18 L1 VLP AS04 vaccine administered intramuscularly according to a 0, 1...
    Medical condition: Cervarix is indicated in females from 10 years of age onwards for the prevention of premalignant cervical lesions and cervical cancer causally related to Human Papillomavirus (HPV) types 16 and 18....
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: PT (Completed)
    Trial results: View results
    EudraCT Number: 2011-005604-15 Sponsor Protocol Number: 115887 Start Date*: 2015-10-07
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III, randomised, controlled, single-blind study to evaluate the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals’ HPV-16/18 L1 VLP AS04 vaccine administered according to a 2-d...
    Medical condition: Healthy volunteers
    Disease:
    Population Age: Children, Under 18 Gender: Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2012-003025-25 Sponsor Protocol Number: 112022 Start Date*: 2015-06-11
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III, double-blind, randomized, controlled study to evaluate the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ HPV-16/18 L1 VLP AS04 vaccine administered intramuscularly ac...
    Medical condition: Healthy volunteers
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2007-007876-41 Sponsor Protocol Number: 111567 Start Date*: 2008-03-07
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase IIIb, randomized, open study to evaluate the immunogenicity and safety of GlaxoSmithKline Biologicals’ Hepatitis B vaccine (Engerix-B™) when co-administered with GlaxoSmithKline Biologicals...
    Medical condition: Cervarix™ is indicated 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:
    Population Age: Adults Gender: Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2005-001667-58 Sponsor Protocol Number: 104772 Start Date*: 2005-10-10
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase III, double-blind, randomized study to assess the consistency of the immunogenicity of three consecutive production lots of GlaxoSmithKline Biologicals’ HPV-16/18 L1/AS04 vaccine administer...
    Medical condition: For active immunization of women from the age of 10 onwards to prevent persistent HPV-16 and HPV-18 infection and HPV-16 and HPV-18 associated cervical neoplasia.
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: LT (Completed) DK (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: 2005-005943-24 Sponsor Protocol Number: 580299/011 Start Date*: 2006-03-29
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase I/II, observer-blind, randomized, controlled study to assess the immunogenicity and safety of GlaxoSmithKline Biologicals’ HPV-16/18 L1/AS04 vaccine administered intramuscularly according t...
    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: Male
    Trial protocol: FI (Completed)
    Trial results: View results
    EudraCT Number: 2007-006651-39 Sponsor Protocol Number: 111103 Start Date*: 2008-12-22
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase IV, randomized, open-label, controlled, post-licensure study to evaluate the safety of GlaxoSmithKline Biologicals’ HPV-16/18 L1 VLP AS04 vaccine (Cervarix®) when administered intramuscular...
    Medical condition: No medical condition will be investigated in this study. The study will follow vaccinated females and collect safety data focussing on autoimmune diseases, pregnancy outcomes and SAEs considered to...
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: GB (Prematurely Ended)
    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: 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: 2007-004347-30 Sponsor Protocol Number: 110886 Start Date*: 2007-11-07
    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 VLP AS04 vaccine co-administered with GlaxoSmithKline Biolog...
    Medical condition: For active immunization of females from the age of 10 years onwards for the prevention of cervical cancer by protecting against incident and persistent infections, cytological abnormalities includi...
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Female
    Trial protocol: SE (Completed) HU (Completed) DK (Completed)
    Trial results: View results
    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: 2008-000369-44 Sponsor Protocol Number: 111375 Start Date*: 2009-03-24
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A long-term, open follow-up of the immunogenicity and safety of GlaxoSmithKline Biologicals’ HPV-16/18 VLP/AS04 vaccine in healthy female subjects up to 10 years after administration of the first v...
    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:
    Population Age: Adolescents, Under 18, Adults Gender: Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2004-001173-26 Sponsor Protocol Number: 580299/012,107476 - 477 - 479 - 481 Start Date*: 2004-10-08
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: Long-term follow-up: A long-term, open, follow-up of the immunogenicity and safety of the vaccine in healthy female subjects vaccinated either pre- or post-menarche in the HPV-012 study. Primary: A...
    Medical condition: For active immunization of women from the age of 10 years onwards to prevent persistent HPV-16 and HPV-18 infection and HPV-16 and HPV-18 associated cervical neoplasia.
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Female
    Trial protocol: DK (Completed) FI (Completed)
    Trial results: View results
    EudraCT Number: 2014-000060-17 Sponsor Protocol Number: 200255 Start Date*: 2014-05-09
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase IIIb, open-label, non-randomised, multicentre study to assess the immunogenicity and safety of GSK Biologicals’ HPV-16/18 L1 VLP AS04 vaccine when administered intramuscularly according to ...
    Medical condition: Healthy volunteers [For active immunisation of females from 9 years of age onwards for the prevention of persistent infection, premalignant genital (cervical, vulvar and vaginal) lesions and cervic...
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004865 10071147 Human papilloma virus immunization LLT
    16.1 100000004848 10058580 Human papilloma virus serology test LLT
    Population Age: Adolescents, Under 18, Adults Gender: Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2007-000164-24 Sponsor Protocol Number: 109836 Start Date*: 2007-05-21
    Sponsor Name:GlaxoSmithKline Biologicals
    Full Title: A phase I/II, partially-blind, randomized multicentre study to assess the safety and immunogenicity of an HPV-16/18/33/58 L1 VLP vaccine formulated with different adjuvant systems when administered...
    Medical condition: Healthy volunteers
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2012-000445-12 Sponsor Protocol Number: IPAR0001 Start Date*: 2012-07-17
    Sponsor Name:Department off Infectious Diseases, Aarhus University Hospital Skejby, Denmark
    Full Title: Immune Response to Bivalent or Quadrivalent Human Papilloma Virus vaccination in Patients with Chronic Renal Failure
    Medical condition: Cervical cancer
    Disease: Version SOC Term Classification Code Term Level
    14.1 10042613 - Surgical and medical procedures 10071147 Human papilloma virus immunization LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Prematurely Ended)
    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
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    1  2  Next»
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Fri May 09 06:10:03 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA