Evaluation of the Immunogenicity and Safety of a Commercially Available Vaccine When Co-administered With GlaxoSmithKline Biologicals' HPV Vaccine (580299) in Healthy Female Subjects.
- 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 between, and including, 20 and 25 years of age at the time of the first
- Written informed consent obtained from the subject.
- Healthy subjects as established by medical history and history directed clinical
examination before entering into the study.
- Subjects must not be pregnant.
- Subjects 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 2 months after
completion of the vaccination series.
- Use of any investigational or non-registered product (drug or vaccine) other than the
study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned
use during the study period.
- 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 each dose of vaccine. Administration of
routine vaccines such as meningococcal, inactivated influenza, diphtheria/tetanus
and/or diphtheria/tetanus-containing vaccines up to 8 days before the first dose of
study vaccine is allowed.
- Concurrently participating in another clinical study, at any time during the study
period (up to Month 13), in which the subject has been or will be exposed to an
investigational or a non-investigational product (pharmaceutical product or device).
- A subject planning to become pregnant, likely to become pregnant (as determined by
the investigator) or planning to discontinue contraceptive precautions during the
study period and up to two months after the last vaccine dose.
- Pregnant or breastfeeding women.
- 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.
- Previous vaccination against hepatitis B or planned administration of any hepatitis B
vaccine other than that foreseen by the study protocol during the study period.
- History of hepatitis B infection.
- Known exposure to hepatitis B within the previous 6 weeks.
- Known acute or chronic, clinically significant neurologic, hepatic or renal
functional abnormality, as determined by previous physical examination or laboratory
- Cancer or autoimmune disease under treatment.
- History of allergic disease or reactions likely to be exacerbated by any component of
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
medical history and physical examination
- Acute disease at the time of enrolment.
- 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