NCT00344032

Evaluation of the Immune and Safety Response of GlaxoSmithKline (GSK) Biologicals' HPV Vaccine in Healthy Indian Women

Phase IIIb, Double-blind, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of GSK Biologicals' HPV-16/18 VLP/AS04 Vaccine Administered Intramuscularly at 0, 1, 6 Months in Healthy Indian Female Subjects Aged 18-35 Yrs

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 354 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

Human papillomavirus infection has clearly been recognized as the cause of cervical cancer. Indeed, the infection of the cervix by certain oncogenic types of HPV, if not cleared , can lead over time to cervical cancer in women . This study will evaluate the immune response induced by the HPV-16/18 L1/AS04 vaccine and the safety of the 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	Placebo	Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
BIOLOGICAL	HPV-16/18 VLP/AS04 Vaccine (Cervarix TM)	Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.

Timeline

• Start date: 2006-07-28
• Primary completion: 2007-12-01
• Completion: 2007-12-04
• First posted: 2006-06-26
• Last updated: 2018-07-20
• Results posted: 2009-12-15

Locations

4 sites across 1 country: India