A Multicentre Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' HPV Vaccine (GSK1674330A) in Healthy Female Subjects Aged 18-25 Years.
- A woman whom the investigator believes can and will comply with the requirements of
- A woman between, and including, 18 and 25 years of age at the time of the first
- Written informed consent must be obtained from the subject prior to enrolment.
- Healthy subjects as established by medical history and clinical examination before
entering into the study.
- Subject must be of non-childbearing potential, or if of child bearing potential, she
must have a negative pregnancy test and she must be using adequate contraceptive
precautions for 30 days prior to the first vaccination and must agree to continue
such precautions for two months after completion of the vaccination series.
- Subject who has had no more than 6 lifetime sexual partners prior to enrolment.
- Use of any investigational or non-registered product (drug or vaccine) other than the
study vaccine within 30 days preceding the first dose of study vaccine, or planned
use up to six months after last dose of vaccine.
- Concurrently participating in another clinical study, at any time during the study
period (up to six months after last dose of vaccine), in which the subject has been
or will be exposed to an investigational or a non-investigational product
(pharmaceutical product or device).
- Chronic administration of immunosuppressants or other immune-modifying drugs within
six months prior to the first vaccine dose or planned during the study period up to
one month after last dose of vaccine.
- Planned administration/administration of a vaccine not foreseen by the study protocol
within 30 days before and 30 days after (i.e. days 0-29) the first dose of study
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. Women must be at least 3 months post-pregnancy and not
breastfeeding to enter the study.
- 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.
- Previous administration of components of the investigational vaccine
- Any medically diagnosed or suspected immunodeficient condition based on medical
history and physical examination of allergic disease, suspected allergy 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 allergic disease, suspected allergy or reactions likely to be exacerbated
by any component of the study vaccines.
- History of having had colposcopy or has planned a colposcopy to evaluate an abnormal
cervical cytology test.
- Received immunoglobulins and/or blood product within 3 months preceding enrolment or
planned administration during the study period up to one month after the last dose of
vaccine. Enrolment will be deferred until the subject is outside of specified window.
- Acute disease at the time of enrolment.
- Heavy bleeding (menstruation or other) or heavy vaginal discharge in which a cervical
sample cannot be collected. Enrolment will be deferred until condition is resolved
according to investigators medical judgement.