NCT00316693

Human Papillomavirus (HPV) Vaccine (Cervarix TM) Efficacy, Immunogenicity & Safety Trial in Adult Japanese Women With GSK Biologicals HPV-16/18 Vaccine

A Phase II Study to Assess the Efficacy, Immunogenicity and Safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 (Cervarix TM) Vaccine Administered Intramuscularly According to a 0, 1, 6 Month Schedule in Healthy Japanese Female Subjects Aged 20 - 25 Years.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,046 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 20 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. This study will evaluate the efficacy in prevention of persistent HPV-16 or HPV-18 cervical infection lasting at least 6 months, the immunogenicity and safety of GSK Biologicals HPV-16/18 vaccine (Cervarix TM ) over 24 months in Japanese adult women aged 20 - 25 years of age at study start. Approximately 1000 study subjects will either receive the HPV vaccine or a control vaccine (Hepatitis A vaccine) administered intramuscularly according to a 0-1-6 month schedule. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Detailed description

The Protocol Posting has been updated to reflect changes as a consequence of an amendment to the protocol. Sections impacted are Official Title of the study and Intervention name.

Conditions

• Infections, Papillomavirus

Interventions

Type	Name	Description
BIOLOGICAL	HPV-16/18 vaccine (Cervarix™)	Intramuscular injection, 3 doses
BIOLOGICAL	Aimmugen™	Intramuscular injection, 3 doses

Timeline

• Start date: 2006-04-26
• Primary completion: 2009-02-10
• Completion: 2009-02-10
• First posted: 2006-04-21
• Last updated: 2018-09-04
• Results posted: 2009-12-16

Locations

4 sites across 1 country: Japan