NCT00485732

A Study to Evaluate the Immune Response and Safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine/Cervarix TM Vaccine in Healthy Females Aged 15-25 Years

A Phase IIIb, Double-blind, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV-16/18 L1 VLP AS04 Vaccine, Administered Intramuscularly in Healthy Female Subjects Aged 15 - 25 Years

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 225 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 15 Years – 25 Years
• Healthy volunteers: Accepted

Summary

Human papillomavirus infection has clearly been recognized as the cause of cervical cancer. The infection of the cervix by certain oncogenic types of HPV, if not cleared, can lead to cervical cancer in women. This study will evaluate the immunogenicity and safety of the GSK Biologicals' HPV-16/18 L1 VLP AS04 vaccine (Cervarix TM) vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

• Infections, Papillomavirus

Interventions

Type	Name	Description
BIOLOGICAL	HPV-16/18 VLP/AS04 vaccine (Cervarix TM)	Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
BIOLOGICAL	Placebo	Three doses of placebo administered intramuscularly according to a 0, 1, 6-month schedule.

Timeline

• Start date: 2007-06-11
• Primary completion: 2008-03-30
• Completion: 2008-03-30
• First posted: 2007-06-13
• Last updated: 2018-07-20
• Results posted: 2009-12-17

Locations

6 sites across 1 country: South Korea