study to assess immune responses and safety of the gsk-580299 vaccine in healthy women (26 to 45 years)

Conditions: Infections, Papillomavirus

Summary: this study is designed to evaluate the immunogenicity and safety of gsk biologicals' human papillomavirus (hpv) vaccine in adult female subjects aged 26-45 years. one group of subjects will receive the hpv vaccine and the other group will receive an active control (gsk biologicals' hepatitis b vaccine). immunogenicity data of the hpv group will be compared with those from the hpv group included in the nct00779766 study (aged 18-25 years).

this protocol posting has been updated following protocol amendment 1, december 2010, leading to: * the removal of 3 outcome measures * the update of 1 outcome measure

Eligibility criteria:
inclusion criteria: * written informed consent prior to study enrolment. * healthy adult females from chinese origin and residing in china between and including 26 and 45 years of age at the time of the first vaccination. * subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. * healthy subjects as established by medical history and history-directed clinical examination before entering into the study. * subjects must not be pregnant. absence of pregnancy will be verified with a urine pregnancy test before each vaccination. subjects must be of non-childbearing potential, i.e., have a current tubal ligation, hysterectomy, ovariectomy, be one year post-menopausal, or if of childbearing potential, they must be abstinent or have practiced adequate contraception for 30 days prior to vaccination, have a negative pregnancy test on the day of vaccination and agree to continue such precautions during the entire treatment period and for 2 months after completion of the vaccination series. exclusion criteria: * use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period. * chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after the first dose of vaccine. * concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). * a subject planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the study period and up to two months after the last vaccine dose. * pregnant or breastfeeding subjects must be at least three months post-pregnancy and not breastfeeding to enter the study. * previous vaccination against hpv or planned administration of any hpv vaccine other than that foreseen by the protocol during the study period. * previous administration of 3-o-desacyl-4'-monophosphoryl lipid a or as04 adjuvant. * previous vaccination against hepatitis b or planned administration of any hepatitis b vaccine other than that foreseen by the study protocol during the study period. * history of hepatitis b infection. * known exposure to hepatitis b within the previous 6 weeks. * history of chronic condition(s) requiring treatment such as cancer or autoimmune disease. * history of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the vaccine (e.g. aluminium). * hypersensitivity to latex. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * acute disease at the time of enrolment. * administration of immunoglobulins and/or blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.

Keywords: safety hpv vaccine immune response human papillomavirus china