NCT00877877

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

Follow-up Study to Evaluate the Long-term Immunogenicity and Safety of a HPV Vaccine (GSK 580299) in Healthy Female Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 632 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 15 Years – 24 Years
• Healthy volunteers: Accepted

Summary

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).

Detailed description

Subjects were aged 10-14 years at the time of entry into the primary study. No vaccine will be administered in this extension study. Results on outcome measures describing analyses on other studies are not reported in this record. Please refer to the records mentioned in the respective outcome measure titles.

Conditions

• Infections, Papillomavirus
• Papillomavirus Vaccines

Interventions

Type	Name	Description
PROCEDURE	Blood sampling	Blood samples were to be collected at Months 60, 72, 84, 96, 108 and 120

Timeline

• Start date: 2009-05-07
• Primary completion: 2015-01-06
• Completion: 2015-01-06
• First posted: 2009-04-08
• Last updated: 2020-01-18
• Results posted: 2011-04-27

Locations

26 sites across 5 countries: Colombia, Germany, Honduras, Panama, Taiwan