A Phase III, Double-blind, Randomized, Controlled Study to Evaluate Immunogenicity & Safety of GSK Biologicals' HPV-16/18 L1 VLP AS04 Vaccine, Administered Intramuscularly (0, 1, 6 Month Schedule) in Healthy Females Aged 18 - 35 Years
- Subjects who the investigator believes that they can and will comply with the
requirements of the protocol should be enrolled in the study.
- A female of Chinese origin, residing in Hong Kong aged between, and including, 18 and
35 years at the time of the first vaccination.
- Written informed consent obtained from the subject.
- Healthy subjects as established by medical history and clinical examination before
entering into the study.
- Subjects must have a negative urine pregnancy test.
- Subjects of childbearing potential at the time of study entry must be abstinent or
must be using adequate contraceptive precautions for 30 days prior to vaccination and
must agree to continue such precautions for two months after completion of the
- Use of any investigational or non-registered product (drug or vaccine) other than the
study/ control vaccine within 30 days preceding the first dose of study/ control
vaccine, or planned use during the study period.
- Pregnant or breastfeeding.
- Planning to become pregnant or likely to become pregnant.
- 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. Administration of
routine vaccines up to 8 days before the first dose of study vaccine is allowed.
Enrolment will be deferred until the subject is outside of specified window.
- Previous administration of components of the investigational vaccine.
- Previous vaccination against HPV or planned administration of any HPV vaccine other
than that foreseen by the study protocol during the study period.
- Any medically diagnosed or suspected immunodeficient condition based on medical
history and physical examination.
- History of allergic disease, suspected allergy or reactions likely to be exacerbated
by any component of the study/ control vaccines.
- Hypersensitivity to latex.
- Known acute or chronic, clinically significant neurologic, pulmonary, cardiovascular,
hepatic or renal functional abnormality, as determined by previous physical
examination or laboratory tests.
- History of chronic condition(s) requiring treatment.
- Administration of immunoglobulins and/or any blood product within three months
preceding the first dose of study/ control vaccine or planned administration during
the study period. Enrolment will be deferred until the subject is outside of
- Acute disease at the time of enrolment.