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Infections, Papillomavirus clinical trials

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NCT ID: NCT00996125 Completed - Clinical trials for Infections, Papillomavirus

Immunogenicity and Safety Study of GSK Biologicals' Human Papillomavirus 580299 Vaccine in Healthy Female Subjects

Start date: October 24, 2009
Phase: Phase 3
Study type: Interventional

This study is designed to evaluate the immunogenicity and safety of GlaxoSmithKline Biologicals' human papillomavirus (HPV) vaccine in pre-teen and adolescent female subjects aged 9 - 17 years. One group of subjects will receive the HPV vaccine and the other group will receive the control.

NCT ID: NCT00947115 Completed - Clinical trials for Infections, Papillomavirus

Evaluation of Long-term Immunogenicity and Safety of a Human Papillomavirus (HPV) Vaccine in Healthy Female Subjects

Start date: September 22, 2009
Phase: Phase 3
Study type: Interventional

Infection with human papillomavirus (HPV) has been clearly established as the necessary cause of cervical cancer. This study is designed to evaluate the long-term immunogenicity and safety of the GSK Biologicals' 580299 HPV vaccine up to 10 years after administration of the first dose of HPV vaccine (Month 0) in primary study NCT00196937. This protocol posting deals with objectives & outcome measures of the extension phase from Year 5 to Year 10. The objectives & outcome measures of the primary phase and extension phase up to year 4 are presented in a separate protocol posting (NCT00196937).

NCT ID: NCT00937950 Completed - Clinical trials for Infections, Papillomavirus

Gynaecological Follow-up of a Subset of 580299/008 (NCT00122681) Study Subjects

Start date: August 5, 2009
Phase: Phase 3
Study type: Interventional

This study is designed to provide up to four years of annual oncogenic HPV DNA testing and cervical cytology examination for NCT00122681 study subjects who displayed normal cervical cytology but tested positive for oncogenic HPV infection at their last NCT00122681 study visit (Visit 10, Month 48). This follow-up study will also be offered to subjects who were pregnant at their last NCT00122681 study visit (Visit 10, Month 48) so that no cervical sample could be collected at that visit. The objectives & outcome measures of the primary phase (study 008/580299) are presented in a separate protocol posting (NCT00122681).

NCT ID: NCT00924794 Terminated - Clinical trials for Infections, Papillomavirus

Study of Natural History of Human Papillomavirus (HPV) Infections in Adult Women With Recurrent Conizations in Norway

Start date: June 2010
Phase: N/A
Study type: Observational

This is a register-based, epidemiological study of HPV type distribution in women aged 18 years and above with recurrent conization following a primary conization for high grade lesions/ microinvasive carcinomas. This study will involve data collection from different databases in the Cancer Registry of Norway.

NCT ID: NCT00877877 Completed - Clinical trials for Infections, Papillomavirus

Evaluation of Long-term Immunogenicity and Safety of a Human Papillomavirus (HPV) Vaccine in Healthy Female Subjects.

Start date: May 7, 2009
Phase: Phase 3
Study type: Interventional

Infection with human papillomavirus (HPV) has been clearly established as the necessary cause of cervical cancer. This study is designed to evaluate the long-term immunogenicity and safety of the 580299 HPV vaccine up to 10 years after administration of the first dose of HPV vaccine (Month 0) administered in the primary study 580299/013. This protocol posting deals with objectives & outcome measures of the extension phase from Month 60 to Month 120. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT00196924). The objectives & outcome measures of the extension phase up to Month 48 are presented in a separate protocol posting (NCT00316706).

NCT ID: NCT00849381 Completed - Clinical trials for Infections, Papillomavirus

Safety Study of GSK Biologicals' Human Papillomavirus Vaccine in 580299/008 Subjects From Brazil, Taiwan or Thailand

Start date: April 2009
Phase: Phase 3
Study type: Interventional

This phase 3b study is designed to assess the safety of GlaxoSmithKline Biological's HPV vaccine GSK580299 in female subjects who took part in study 008/580299 and received the control vaccine (Hepatitis A vaccine).

NCT ID: NCT00799825 Completed - Clinical trials for Infections, Papillomavirus

Safety Study of GSK Biologicals' Human Papillomavirus Vaccine in 580299/008 Subjects From Canada or the US

Start date: January 1, 2009
Phase: Phase 3
Study type: Interventional

This phase 3b study is designed to assess the safety of GlaxoSmithKline Biological's HPV vaccine GSK580299 in female subjects who took part in study 580299/008 and received the control vaccine (Hepatitis A vaccine).

NCT ID: NCT00779766 Completed - Clinical trials for Infections, Papillomavirus

Efficacy, Immunogenicity and Safety of GSK Biologicals' HPV GSK 580299 Vaccine in Healthy Chinese Female Subjects

Start date: October 22, 2008
Phase: Phase 3
Study type: Interventional

This is a multicenter study in which women are planned to receive either the HPV vaccine or control. Study participation will last approximately 72 months and involves a total of thirteen or fourteen scheduled visits. Originally, the study was planned for 24 months. It was then extended for 2 more years with 4 additional visits (study end at Month 48). The protocol posting has been updated as the study was extended by additional 2 years with two or three additional visits (study end at Month 72) for subjects who consent to participate in the extension.

NCT ID: NCT00693966 Completed - Clinical trials for Infections, Papillomavirus

Dose-Comparison Study to Evaluate the Safety and Immunogenicity of MEDI-517 (GSK 580299) in Healthy Adult Females

Start date: October 1999
Phase: Phase 2
Study type: Interventional

The purpose of this Phase II study is to provide data regarding the safety and immunogenicity for a range of dose levels of MEDI-517 in women who are HPV-16/18 seronegative and negative for high-risk HPV DNA. The study is designed to evaluate safety and immunogenicity data for MEDI-517 when formulated with either AS04 or aluminum hydroxide. Extended follow-up will provide long-term immune response data. This study was originally performed by MedImmune. However, GSK is now responsible for the clinical development of the HPV vaccine.

NCT ID: NCT00693615 Completed - Clinical trials for Infections, Papillomavirus

Safety and Immunogenicity Study of MEDI-517 (GSK 580299) With or Without Adjuvant in Healthy Adult Females

Start date: October 2000
Phase: Phase 2
Study type: Interventional

The goals of this study are to describe the safety, reactogenicity and immunogenicity of MEDI-517 with and without adjuvant in HPV-naïve humans. Long-term immune data is collected. This study was originally performed by MedImmune. However, GSK is now responsible for the clinical development of the HPV vaccine.