Evaluation of the Safety and Immunogenicity of GSK Bio's HPV Vaccine 580299 When Administered in Healthy Females Aged 9 - 25 Years Using an Alternative Schedule and an Alternative Dosing as Compared to the Standard Schedule and Dosing
- Subjects who the investigator believes that they and/or their parents can and will
comply with the requirements of the protocol should be enrolled in the study.
- A female subject between, and including, 9 and 25 years of age at the time of the
- Written informed consent/assent obtained from the subject prior to enrolment. For
subjects above the legal age of consent, written informed consent must be obtained
from the subject. For subjects below the legal age of consent, written informed
consent from the subject's parents/legally acceptable representative, and written
informed assent must be obtained from the subject.
- Healthy subjects as established by medical history and history-oriented clinical
examination before entering into the study.
- Subject must be of non-childbearing potential, or if she is of childbearing
potential, she must practice adequate contraception for 30 days prior to vaccination,
have a negative pregnancy test and continue such precautions for two months after
completion of the vaccination series.
- 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 24).
- Chronic administration (defined as more than 14 days) of immunosuppressants or other
immune-modifying drugs within six months prior to the first vaccine dose.
- Concurrently participating in another clinical study, at any time during the study
period (up to Month 24), in which the subject has been or will be exposed to an
investigational or a non-investigational product (pharmaceutical product or device).
- 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. Planned
administration/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.
- Pregnant or breastfeeding female.
- A woman planning to become pregnant or planning to discontinue contraceptive
precautions during the study period, up to two months after the last vaccine dose.
- Previous vaccination against HPV or planned administration of any HPV vaccine other
than that foreseen by the study protocol during the study period (up to Month 24).
- Previous administration of components of the investigational vaccine.
- Cancer or autoimmune disease under treatment.
- Any medically diagnosed 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
- Hypersensitivity to latex.
- 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 tests.
- 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
period (up to Month 24).