NCT00518336

Follow-up Study to Evaluate the Long-term Efficacy of the HPV Vaccine (580299) in Healthy Young Adult Women in Brazil

Follow-up Study to Evaluate the Long-term Efficacy of a HPV Vaccine (580299) in Healthy Young Adult Women in Brazil

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 433 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 15 Years – 25 Years
• Healthy volunteers: Accepted

Summary

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. This Phase IIb study is designed to evaluate the the long-term efficacy, safety and immunogenicity of the 580299 HPV vaccine (CervarixTM) in a Brazilian cohort of women vaccinated in the phase IIb, blinded, primary study 580299/001 (NCT00689741) and having participated in follow-up study 580299/007 (NCT00120848). Only subjects who participated in the primary \& follow-up study will be enrolled in this long-term follow-up study. Subjects were aged 15-25 years at the time of entry into the primary study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed description

In this extension study, women who were vaccinated in the primary study, and participated in the follow-up study, will be followed with visits every 6 months.

Conditions

• Infections, Papillomavirus

Interventions

Type	Name	Description
PROCEDURE	Blood sampling	Blood sampling at Visit 3, 5 and 7.
PROCEDURE	Collection of cervical specimen	Collection of cervical specimen at Visit2, 3, 4, 5, 6 and 7.
BIOLOGICAL	Cervarix	Three doses administered intramuscularly at 0, 1 and 6 months.

Timeline

• Start date: 2007-11-01
• Primary completion: 2008-07-01
• Completion: 2010-09-01
• First posted: 2007-08-20
• Last updated: 2016-12-09
• Results posted: 2011-10-25

Locations

5 sites across 1 country: Brazil