Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb). This infection may go 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. GlaxoSmithKline Biologicals has developed a HPV vaccine against the oncogenic types HPV-16 and HPV-18 formulated with the AS04 adjuvant (control vaccine) and is also evaluating novel HPV vaccines formulations. This study will evaluate a novel GSK Biologicals' HPV vaccine (GSK1674330A) in terms of safety and immunogenicity compared to the control vaccine. There will be different levels of blinding in the study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
540
Intramuscular administration, 5 different formulations
Intramuscular administration
GSK Investigational Site
Brussels, Belgium
GSK Investigational Site
Ghent, Belgium
GSK Investigational Site
Wilrijk, Belgium
Occurrence, intensity and relationship to vaccination of any solicited local or general symptoms
Time frame: Within 7 days after each vaccine dose
Occurrence of serious adverse events
Time frame: Up to one month after the last dose of vaccine
Occurrence, intensity and relationship to vaccination of any unsolicited symptom
Time frame: Within 30 days after each vaccine dose
Occurrence of clinically relevant abnormalities in biochemical and hematological parameters
Time frame: Assessed at Month 0, one month and six months after the last dose of vaccine
Occurrence of serious adverse events during the extended safety follow-up
Time frame: Up to six months after the last dose of vaccine
Occurrence of pregnancy and pregnancy outcomes, new onset chronic diseases or medically significant conditions, regardless of causal relationship to vaccination
Time frame: Throughout the study period (Month 0 up to six months after the last dose of vaccine)
HPV-16 and HPV-18 seropositivity rates and GMTs before the second dose of vaccine
Time frame: One month after the second dose of vaccine, and six months after the last dose of vaccine
Seropositivity rates to other defined HPV types and GMTs before the second dose of vaccine
Time frame: One month after the second dose of vaccine and at one month and six months after the last dose of vaccine
HPV-16 and -18 seropositivity rates and GMTs
Time frame: One month after the last dose of vaccine
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