Infections, Papillomavirus Clinical Trial
Official title:
A Phase III, Double-blind, Randomized, Controlled, Multi-center Study to Evaluate the Efficacy of GlaxoSmithKline Biologicals. HPV-16/18 VLP AS04 Vaccine Compared to Hepatitis A Vaccine as Control in Prevention of Persistent HPV-16 or HPV-18 Cervical Infection and Cervical Neoplasia, Administered Intramuscularly According to a 0, 1, 6 Month Schedule in Healthy Females 15-25 Years of Age.
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.
NOTE: Some 178 centers participate in this study. Given that the recruitment is completed, the researchers have listed one center per country in this website. If required, further details of centers available on request. ;
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