was conducted in 28 centers in Brazil, Canada
and the U.S. and evaluated the efficacy, safety and immunogenicity of GSK's
candidate vaccine for the prevention of infection with cancer causing virus
types 16 and/or 18, and other cancer-causing virus types, as well as
prevention of associated Pap smear abnormalities and cervical precancerous
lesions. In the extended follow-up study, women were evaluated for the
presence of human papillomavirus DNA by PCR using cervical samples and
annual cervical cytology evaluations were performed. Women were referred
for colposcopy following protocol guidelines. Women were also assessed for
long-term immunogenicity and safety.
About cervical cancer and its progression
Approximately 100 types of human papillomavirus have been identified to
date and, of these, approximately 15 virus types are known to cause
cervical cancer. Virus types 16, 18, 45 and 31 are responsible for
approximately 80 percent of cervical cancers globally. Persistent infection
with cancer-causing virus types can lead to the formation of abnormal cells
in the cervix, which, over time, may become precancerous or cancerous.
Human papillomavirus is a necessary precursor of cervical cancer.
Throughout their lifetime, women may be exposed to cancer-causing virus
types and are potentially at risk of developing cervical cancer.
Worldwide, more than 500,000 women will be newly diagnosed with
cervical cancer and over 280,000 women will die from it each year.
About the GSK Cervical Cancer Vaccine
To date, CERVARIX(R) has been approved in more than 60 countries around
the world including the 27 member countries of the European Union, Mexico,
Australia, Singapore and the Philippines. Licensing applications have been
submitted in more than 35 additional countries including Japan. GSK also
submitted CERVARIX(R) to the World Health Organization (WHO) for
prequalification in September 2007.
GSK submitted a Biologics License Application (BLPage: 1 2 3 4 5 6 Related medicine technology :1
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