NCT00294047

Study to Evaluate the Efficacy of the Human Papillomavirus Vaccine in Healthy Adult Women of 26 Years of Age and Older

A Study to Evaluate Safety, Immunogenicity and Efficacy of GSK Biologicals HPV-16/18 L1/AS04 Vaccine Administered Intramuscularly According to a Three-dose Schedule (0, 1, 6 Month) in Healthy Adult Female Subjects Aged 26 Years and Above

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 5,752 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 26 Years
• Healthy volunteers: Accepted

Summary

This is a multicentre study in which women were planned to receive either the Human Papillomavirus Vaccine (HPV) vaccine or control. Under Protocol Amendment 3, study participation will last approximately 48 months and involves a total of eleven scheduled visits. Under Protocol Amendment 4, study participation will last up to 84 months and involves a maximum of seventeen scheduled visits.

Detailed description

The Protocol Posting has been updated due to protocol amendment 5 and in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

• Infections, Papillomavirus
• Papillomavirus Vaccines

Interventions

Type	Name	Description
BIOLOGICAL	Cervarix	Subjects were planned to receive three doses of the study vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule.
BIOLOGICAL	Placebo control	Subjects were planned to receive three doses of the control vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule.

Timeline

• Start date: 2006-02-16
• Primary completion: 2014-01-29
• Completion: 2014-01-29
• First posted: 2006-02-20
• Last updated: 2020-01-02
• Results posted: 2012-03-27

Locations

75 sites across 12 countries: United States, Australia, Canada, Mexico, Netherlands, Peru, Philippines, Portugal, Russia, Singapore, Thailand, United Kingdom