NCT00929526

Extension Study of the Efficacy of the GSK 580299 Vaccine in Japanese Women Vaccinated in the Primary NCT00316693 Study

Long-term Extension Study of the Efficacy of the 580299 Vaccine in the Prevention of HPV-16 and/or HPV-18 Associated Cervical Intraepithelial Neoplasia (CIN) in Japanese Women Vaccinated in the Primary Vaccination Study NCT00316693

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 752 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 20 Years – 25 Years
• Healthy volunteers: Accepted

Summary

This extension study is conducted to assess the efficacy of the GSK 580299 vaccine against cervical intraepithelial neoplasia (CIN) lesions, cervical cancer and cytological abnormalities associated with human papillomavirus (HPV)-16 and/or HPV-18 or other oncogenic HPV types for an additional two years. All subjects who participated in the primary vaccination study NCT00316693 and who confirmed their interest in participating in a long term follow up study will therefore be invited to be followed for up to 48 months after administration of the first dose of vaccine. In addition, safety and persistence of the humoral immune response will be evaluated in this study. This protocol posting deals with objectives \& outcome measures of the extension phase at Months 36 and 48. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00316693).

Conditions

• Infections, Papillomavirus

Interventions

Type	Name	Description
PROCEDURE	Liquid-based cytology (LBC) sampling	LBC samples will be collected at Months 36 and 48 for cytology and HPV DNA testing (by PCR)
PROCEDURE	Blood sampling	Blood samples will be collected at Months 36 and 48 for antibody determination

Timeline

• Start date: 2009-06-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2009-06-29
• Last updated: 2016-10-20
• Results posted: 2012-10-15

Locations

13 sites across 1 country: Japan