NCT00947115

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 GlaxoSmithKline Biologicals' HPV (580299) Vaccine in Healthy Female Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 525 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 20 Years – 60 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 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).

Detailed description

Subjects were aged 15-55 years at the time of entry into the primary study (NCT00196937). No vaccine was 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

Interventions

Type	Name	Description
PROCEDURE	Blood sampling	Blood samples were collected at Years 5, 6, 7, 8, 9 and 10.
PROCEDURE	Cervico-vaginal secretion (CVS) samples	CVS samples were collected at Years 5, 6, 7, 8, 9 and 10 in subjects who volunteered for this procedure.

Timeline

• Start date: 2009-09-22
• Primary completion: 2015-02-03
• Completion: 2015-02-03
• First posted: 2009-07-27
• Last updated: 2020-10-30
• Results posted: 2011-05-02

Locations

6 sites across 2 countries: Germany, Poland