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Infections, Papillomavirus clinical trials

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NCT ID: NCT01207999 Completed - Cervical Cancer Clinical Trials

Type Distribution of Human Papillomavirus in Adult African Women Diagnosed With Invasive Cervical Cancer

Start date: October 2007
Phase: N/A
Study type: Observational

The aim of the study is to assess the distribution of the most frequent types of human papillomavirus in African women diagnosed with invasive cervical cancer.

NCT ID: NCT01190189 Completed - Clinical trials for Infections, Papillomavirus

Safety Evaluation of the GSK-580299 Vaccine in Women From the Control Group in the Primary NCT00294047 Study

Start date: April 1, 2011
Phase: Phase 3
Study type: Interventional

This extension study is designed to assess the safety of GSK Biological's human papillomavirus (HPV) vaccine GSK580299 in female subjects who took part in the primary study NCT00294047 and received the control vaccine in countries for which the licensed GSK HPV vaccine is not indicated for the subject's age group (26 years and older). This study is thus conducted to enable all women who received the control placebo in the primary NCT00294047 study to receive the GSK580299 vaccine.

NCT ID: NCT01190176 Completed - Clinical trials for Infections, Papillomavirus

Gynaecological Follow-up of a Subset of HPV-015 (NCT00294047) Study Subjects

Start date: September 12, 2011
Phase: Phase 3
Study type: Interventional

This study is intended to provide up to a maximum of four years of annual oncogenic human papillomavirus (HPV) DNA testing and cervical cytology examination for NCT00294047 study subjects who displayed normal cervical cytology but tested positive for oncogenic HPV infection at their concluding NCT00294047 study visit. Women who were pregnant at their concluding NCT00294047 study visit may also be included in this study, as no cervical sample could be collected at that visit. The objectives and outcome measures of the primary phase (NCT00294047) are presented in a separate protocol posting.

NCT ID: NCT01187927 Completed - Clinical trials for Infections, Papillomavirus

Drug Use Investigation for Cervarix®

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

This post-marketing study was designed to assess safety and efficacy of Cervarix® vaccine in Japanese female subjects under conditions of actual use.

NCT ID: NCT01153906 Completed - Clinical trials for Infections, Papillomavirus

Post-marketing Safety Study of Autoimmune Diseases Following Cervarix® Vaccination

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

The purpose of this post-marketing study is to evaluate the incidence of autoimmune diseases (AIDs) following females who have received at the least the first dose of Cervarix® as part of their routine health care.

NCT ID: NCT01101542 Completed - Clinical trials for Infections, Papillomavirus

Evaluation of Safety of a Vaccine Against Cervical Cancer in Healthy Korean Females

Start date: July 1, 2010
Phase:
Study type: Observational

This Post Marketing Surveillance (PMS) will collect safety data on the use of GSK Biologicals' human papillomavirus (HPV) vaccine in the local target population of females as per the regulations of the Korean Food and Drugs Administration (KFDA).

NCT ID: NCT01031069 Completed - Clinical trials for Infections, Papillomavirus

Evaluation of Safety and Immunogenicity of a Human Papillomavirus (HPV) Vaccine in Human Immunodeficiency Virus (HIV) Infected Females

Start date: October 26, 2010
Phase: Phase 4
Study type: Interventional

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. This Phase IV, observer-blind study is designed to evaluate the safety and immunogenicity of Cervarix in HIV infected females aged 15 to 25 years as compared to Merck's HPV vaccine (Gardasil). For comparative purposes, a group of HIV negative females will also be evaluated. All subjects will receive the HPV vaccine (either Cervarix or Gardasil) according to a three-dose schedule (Day 0, Week 6, Month 6).

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).