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

Infections, Papillomavirus Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00344032
Study type Interventional
Source GlaxoSmithKline
Contact
Status Completed
Phase Phase 3
Start date July 28, 2006
Completion date December 4, 2007
View Details
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