First Received: July 20, 2005 Last Updated: June 29, 2010 History of Changes
Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection often goes 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. If a woman is not infected by HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the efficacy of GSK Biologicals HPV 16/18 VLP/AS04 vaccine to prevent infection associated cervical pre-cancer and vaccine with HPV 16 or 18 and the vaccine safety, over 48 months, in young adolescents and women of 15/25 years of age at study start. Approximately 18.000 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.
|Human Papillomavirus (HPV) Infection
Biological: Havrix™-based investigational formulation
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
|Official Title:||Efficacy of GSK Bio HPV Vaccine (580299) vs Hepatitis A Vaccine as Control in Prevention of Persistent HPV-16/18 Cervical Infection & Cervical Neoplasia, Administered Intramuscularly According to 0,1,6 Month Schedule in Healthy Females (15-25 Years)|
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
* Number of Subjects With Histopathologically-confirmed Cervical Intraepithelial Neoplasia (CIN)2+ Associated With HPV-16 and/or -18 Cervical Infection [ Time Frame: Up to the moment when 36 cases of cervical intraepithelial neoplasia (CIN)2+ lesions associated with HPV-16 or HPV-18 infection had been detected, including at least 15 cases of CIN2+ associated with HPV-18 infection. Mean follow-up was 34.9 months. ] [ Designated as safety issue: No ]
CIN2+ was defined as CIN grades 2 and 3, endocervical adenocarcinoma in situ (AIS) and invasive cervical cancer.
Detection was done in subjects HPV deoxyribonucleic acid (DNA) negative (DNA-) at Month 0 and Month 6 and seronegative (sero-) for HPV-16 and/or HPV-18 by Enzyme-linked Immunosorbent Assay (ELISA) at baseline (Month 0) and regardless of initial serostatus (overall).