NCT00196937

Human Papilloma Virus (HPV) Vaccine Immunogenicity and Safety Trial in Young and Adult Women With GSK Biologicals' HPV-16/18

Phase 3, Open, Age-stratified Study to Assess Immunogenicity and Safety of GSK Biologicals' HPV-16/18 Vaccine Administered Intramuscularly According to 3-dose Schedule (0,1,6 Months) in Healthy Female Subjects Aged 15 - 55 Years and Long Term Follow-up

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 667 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 15 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb). This infection may go away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. This study will evaluate the immunogenicity and safety of GSK Biologicals HPV-16/18 vaccine over 12 months, in women up to 55 years of age at study start. Approximately 660 study subjects will receive the HPV vaccine administered intramuscularly according to a 0-1-6 month schedule. The study will be extended to assess long-term safety and immunogenicity of the HPV-16/18 vaccine.

Conditions

• Infections, Papillomavirus

Interventions

Type	Name	Description
BIOLOGICAL	Cervarix	Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.

Timeline

• Start date: 2004-10-07
• Primary completion: 2005-12-15
• Completion: 2005-12-15
• First posted: 2005-09-20
• Last updated: 2019-12-11
• Results posted: 2010-08-06

Locations

6 sites across 2 countries: Germany, Poland