Immunogenicity and Safety of a Commercially Available Vaccine Co-administered With GSK HPV Vaccine (580299)
Condition: Infections, Papillomavirus; Papillomavirus Vaccines
Intervention: Subjects received 3 doses of GSK Biologicals' HPV vaccine (580299) (Cervarix™); Engerix™
Intervention description: Intramuscular administration, 3 doses.; Intramuscular administration, 4 doses.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 152.0
Sex: Female
Minimum age: 20 Years
Maximum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Human papillomavirus (HPV) vaccine; Hepatitis B; Cervical cancer; HPV; Papillomavirus

Summary:

      Infection with human papillomavirus (HPV) has been clearly established as the necessary cause
      of cervical cancer. The current Phase 3b study is designed to assess the immunogenicity and
      safety of a commercially available vaccine co-administered with GlaxoSmithKline Biologicals'
      HPV vaccine GSK580299 in healthy female subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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
             vaccination.

          -  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.

        Exclusion Criteria:

          -  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 tests.

          -  Cancer or autoimmune disease under treatment.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccines.

          -  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
             period.