A Phase II Study to Assess the Efficacy, Immunogenicity and Safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 (Cervarix TM) Vaccine Administered Intramuscularly According to a 0, 1, 6 Month Schedule in Healthy Japanese Female Subjects Aged 20 - 25 Years.
Inclusion criteria :
- Subjects who the investigator/co-investigator believes that they can and will comply
with the requirements of the protocol should be enrolled in the study.
- A Japanese female subject between, and including, 20 and 25 years of age at the time
of the first vaccination.
- Written informed consent obtained from the subject prior to enrolment.
- Healthy subjects as established by medical history and history-oriented clinical
examination before entering into the study.
- Subjects must have a negative urine pregnancy test.
- Subjects must be of non-childbearing potential, she must be abstinent or have used
adequate contraceptive precautions for 30 days prior to vaccination, have a negative
pregnancy test and must agree to continue such precautions for two months after
completion of the vaccination series.
- Subject must have an intact cervix
- Use of any investigational or non-registered product (drug or vaccine) other than the
study vaccine/control within 30 days preceding the first dose of study
vaccine/control, or planned use during the study period.
- Pregnant or breastfeeding women. Women must be at least 3 months post-pregnancy and
not breastfeeding to enter the study.
- A women planning to become pregnant, likely to become pregnant or planning to
discontinue contraceptive precautions during the study period, up to 2 months after
the last vaccine dose
- previous administration of components of the investigational vaccine
- 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. Routine
vaccines may be allowed up to 8 days before the first dose of study vaccine.
- Previous vaccination against HPV.
- History of vaccination against hepatitis A or a known clinical history of hepatitis A
- Administration of immunoglobulin and/or any blood products within the three months
preceding the first dose of study vaccine or planned administration during the study
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on
medical history and physical examination
- History of allergic disease or reactions likely to be exacerbated by any component of
the study vaccines
- Hypersensitivity to latex
- Known acute or chronic, clinically significant pulmonary, cardiovascular, neurologic,
hepatic or renal functional abnormality, as determined by previous physical
examination or laboratory tests.
- Cancer or autoimmune disease under treatment.
- History of having had colposcopy or has planned a colposcopy to evaluate an abnormal
cervical cytology (Pap smear) test.
- Heavy bleeding or heavy vaginal discharge such that a pelvic examination can not be
- Acute disease at the time of enrolment.
- Oral temperature >= 37.5°C / axillary temperature > 37.5°C.
- 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).