Immunogenicity and Safety Study of GSK Biologicals' HPV Vaccine (GSK 580299) in Healthy Adult Chinese Female Subjects
- 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.
- 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
- 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
- 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