NCT00359619

Human Papillomavirus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Biologicals Novel HPV Vaccine

A Long-term, Follow-up of the Immunogenicity and Safety of GlaxoSmithKline Biologicals' Novel HPV Vaccine in Healthy Female Subjects Vaccinated in the Primary Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 383 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 18 Years – 25 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. GlaxoSmithKline Biological's has developed a HPV vaccine against the oncogenic types HPV-16 and HPV-18 formulated with the AS04 adjuvant (control vaccine) and is also evaluating novel HPV vaccines formulations. This study will evaluate the long-term immunogenicity and safety of a novel GSK Biological's vaccine in approximately 376 subjects who received the novel vaccine or the control vaccine administered in the primary study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

• Infections, Papillomavirus
• Papillomavirus Vaccines

Interventions

Type	Name	Description
BIOLOGICAL	CervarixTM	Subjects were administered three doses of HPV vaccine
BIOLOGICAL	HPV investigational vaccine GSK568893A, different formulations	Subjects were administered three doses of HPV investigational vaccine

Timeline

• Start date: 2006-09-12
• Primary completion: 2007-01-30
• Completion: 2007-01-30
• First posted: 2006-08-02
• Last updated: 2020-01-02
• Results posted: 2015-02-10

Locations

10 sites across 2 countries: United States, Belgium