The study will be extended for subjects who received all three doses of vaccine in Finland, Denmark and Estonia to determine long-term safety and immunogenicity of the HPV-16/18 vaccine. 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 consistency of consecutive vaccine lots and the non-inferiority of modified manufacturing processes of GSK Biologicals HPV-16/18 vaccine and the vaccine safety, over 12 months, in young adolescents and women of 10-25 years of age at study start.
Approximately 750 study subjects received different lots of the HPV 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.
Primary Outcome Measures:
- Anti-HPV-16 and anti-HPV-18 antibody titers assessed by ELISA in all subjects [ Time Frame: At each time point (Months 18, 24, 36 and 48) ]
Secondary Outcome Measures:
- Occurrence of pregnancies, SAEs, new onset chronic diseases and other medically significant conditions [ Time Frame: Throughout the study period ]
- Anti-HPV-16 and anti-HPV-18 antibody titers assessed by ELISA [ Time Frame: At each time point (Months 0, 7, 18, 24, 36 and 48) ]
- Anti-HPV-16 and anti-HPV-18 antibody titers from subjects enrolled in studies HPV-001/HPV-007 subjects assessed by ELISA [ Time Frame: At each time point ]
- Anti-HPV-16 and anti-HPV-18 antibody titers in cervical samples in post-menarcheal subjects who volunteered for the procedure. [ Time Frame: At Months 24, 36 and 48 ]
- Total IgG evaluation in blood samples [ Time Frame: At Months 24, 36 and 48 ]
Estimated Enrollment: |
400 |
Study Start Date: |
June 2006 |
Estimated Study Completion Date: |
January 2009 |
Estimated Primary Completion Date: |
January 2009 (Final data collection date for primary outcome measure) |
In the extension phases at Month 18, 24, 36 & 48, no new subjects will be recruited. No vaccination will be administered during this extension phase.