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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
300
GSK Investigational Site
Hong Kong, Hong Kong
Seroconversion rates to HPV-16 and HPV-18 as assessed by enzyme-linked immunosorbent assay (ELISA)
Time frame: At Month 7
Occurrence of SAEs
Time frame: Throughout the study period (up to Month 7)
Occurrence, intensity and relationship to vaccination of solicited general symptoms, and occurrence and intensity of solicited local symptoms
Time frame: During the 7 days after each and any vaccination
Occurrence, intensity and causal relationship to vaccination of unsolicited symptoms
Time frame: Within 30 days after any vaccination
Occurrence of new onset chronic diseases and other medically significant conditions regardless of causal relationship to vaccination and intensity.
Time frame: Throughout the study period (up to Month 7)
Anti-HPV-16/18 antibody titres (by ELISA)
Time frame: At Month 0 and Month 7
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