Study to Assess the Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV Vaccine GSK580299 in Healthy Female Subjects Aged 10-25 Years
- Subjects who the investigator believes that they and/or their parents/legally
acceptable representative can and will comply with the requirements of the protocol
should be enrolled in the study.
- A female between, and including, 10 and 25 years of age at the time of the first
- Written or oral, signed or thumb printed or witnessed informed consent obtained from
the subject prior to enrolment. For subjects below legal age of consent, written or
oral, signed or thumb printed or witnessed informed consent obtained from the
subject's parent or legally acceptable representative. In addition, a written or
oral, signed or thumb printed and witnessed informed assent must be obtained from the
- Free of obvious health problems as established by medical history, clinical
examination and laboratory testing before entering into the study.
- Subjects must have a negative urine pregnancy test at the screening visit and at
Visit 1 (Day 0).
- Subjects must be seronegative for human immunodeficiency virus (HIV) at the screening
- Subjects must be of non-childbearing potential, or, if of 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. Subjects who
reach menarche during the study and therefore are of childbearing potential must
agree to follow the same precautions.
- Subjects must have had no more than 6 sexual partners prior to enrolment.
- Subjects must be willing to undergo HIV voluntary counselling and testing and must be
willing to be informed of their HIV status. Subjects below legal age of consent must
also be willing to have their parent or legally acceptable representative informed of
their HIV status.
- Use of any investigational or non-registered product (drug or vaccine) other than the
study vaccines within 30 days preceding the first dose of study vaccine, or planned
use during the study period (up to Month 12).
- Chronic administration of immunosuppressants or other immune-modifying drugs within
six months prior to the first vaccine dose or planned administration during the study
- Administration of a vaccine not foreseen by the study protocol within 30 days before
the first dose of vaccine. Enrolment will be deferred until the subject is outside of
- Planned administration of a vaccine not foreseen by the study protocol within 30 days
before and 30 days after any dose of study vaccine.
- Previous vaccination against HPV, or planned administration of any HPV vaccine other
than that foreseen by the study protocol during the study period.
- Previous administration of components of the investigational vaccine
- Cancer or autoimmune disease under treatment.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including
HIV infection based on laboratory testing performed during the screening visit.
- Hypersensitivity to latex
- History of allergic disease or reactions likely to be exacerbated by any component of
- Acute disease at the time of enrolment.
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal
functional abnormality, as determined by physical examination or laboratory testing
performed at the screening visit.
- History of any neurologic disorders or seizures.
- Administration of immunoglobulins and/or any blood products within the three months
preceding the first dose of study vaccine or planned administration during the study
- Pregnant or breastfeeding female.
- A women planning to become pregnant, likely to become pregnant or planning to
discontinue contraceptive precautions during the study period, up to two months after
the last vaccine dose.
- 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).