A Study to Evaluate the Immunogenicity and Safety of GSK Biologicals' HPV Vaccine in Healthy Women Aged 18-35 Years.
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 VLP 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.
The protocol was primarily amended for the following reason:
Merck's tetravalent HPV vaccine, Gardasil®, has been licensed and is now becoming commercially available in an increasing number of countries. Therefore, the study procedures were revised to include questions at every visit to determine if subjects have received an HPV vaccine outside of the study.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Human Papillomavirus (HPV) Infection
HPV-16/18 L1 VLP AS04
GSK Investigational Site
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00306241
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Human Papillomavirus 18
A type of human papillomavirus especially associated with malignant tumors of the genital and RESPIRATORY MUCOSA.
Vaccines or candidate vaccines used to prevent PAPILLOMAVIRUS INFECTIONS. Human vaccines are intended to reduce the incidence of UTERINE CERVICAL NEOPLASMS, so they are sometimes considered a type of CANCER VACCINES. They are often composed of CAPSID PROTEINS, especially L1 protein, from various types of ALPHAPAPILLOMAVIRUS.
Papillomavirus E7 Proteins
ONCOGENE PROTEINS from papillomavirus that deregulate the CELL CYCLE of infected cells and lead to NEOPLASTIC CELL TRANSFORMATION. Papillomavirus E7 proteins have been shown to interact with various regulators of the cell cycle including RETINOBLASTOMA PROTEIN and certain cyclin-dependent kinase inhibitors.
Human Papillomavirus 6
A type of ALPHAPAPILLOMAVIRUS usually associated with GENITAL WARTS; and LARYNGEAL NEOPLASMS.
Human Papillomavirus 31
A type of ALPHAPAPILLOMAVIRUS associated with high risk for anogenital neoplasms.
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