Follow-up Study to Evaluate the Safety and Immunogenicity of a HPV Vaccine (580299) in North America
Condition: Infections, Papillomavirus
MeSH terms: Infections
Intervention: Cervarix™
Intervention description: Intramuscular injection, one or three doses
Intervention MeSH terms: Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 116.0
Sex: Female
Minimum age: 15 Years
Maximum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HPV vaccine; Cervical cancer; Human papillomavirus infection

Summary:

      Infection with human papillomavirus (HPV) has been clearly established as the central cause
      of cervical cancer. This study will further evaluate induction of immune memory and
      anamnestic responses in women who previously took part in the primary study (580299/001) and
      follow-up study (580299/007). Subjects were aged 15-25 yrs at the time of entry into the
      primary study and participation in the follow-up study lasted approximately 6 years. In the
      primary and follow-up studies, subjects were protected against HPV-16 and HPV-18 endpoints
      and had sustained antibody responses to both vaccine types over at least 5.5 years of
      follow-up. All subjects from North American study sites that completed the follow-up study
      will be invited to take part in the current study. The study will evaluate the safety and
      immunogenicity of a dose of GSK Biologicals HPV vaccine (580299) in women who had been
      immunologically primed in the primary study.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A subject whom the investigator believes that she can and will comply with the
             requirements of the protocol

          -  Must have received three doses of study vaccine or placebo control in study
             580299/001.

          -  Must have completed study 580299/007.

          -  Written informed consent must be obtained from the subject prior to enrollment in the
             study.

          -  Healthy subjects, as established by medical history and history-directed clinical
             examination before entering into the study.

          -  Subject must have a negative urine pregnancy test.

          -  Subject must be at least three months post-termination of a pregnancy.

          -  Subject must be of non-childbearing potential,or subjects are required to be abstinent
             or use adequate contraceptive precautions for 30 days prior to vaccination. Subjects
             are also required to agree to continue such precautions for two months after
             completion of the vaccination series.

        Exclusion Criteria:

          -  Pregnant or breastfeeding.

          -  A woman planning to become pregnant or planning to discontinue contraceptive
             precautions during the study until approximately 2 months after the last vaccination.

          -  Use of any investigational or non-registered product other than the study vaccine
             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 or planned administration during the study
             period.

          -  Planned administration/administration of a vaccine not foreseen by the study protocol
             within 30 days of each dose of vaccine. Administration of some routine vaccines up to
             8 days before each dose of study vaccine is allowed.

          -  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 outside of
             protocol 580299/001.

          -  Any medically diagnosed or suspected immunosuppressive or 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 vaccines,

          -  Hypersensitivity to latex

          -  Acute or chronic, clinically significant pulmonary, cardiovascular, neurologic,
             hepatic or renal functional abnormality, as determined by physical examination or
             laboratory screening tests.

          -  Cancer or autoimmune disease under treatment.

          -  Administration of immunoglobulins and/or any blood products within the three months
             (90 days) preceding enrollment or planned administration during the study period.

          -  Acute disease at the time of enrollment. All vaccines can be administered to persons
             with a minor illness

          -  Heavy bleeding or heavy vaginal discharge in which a pelvic exam cannot be performed.