Human Papilloma Virus (HPV) Vaccine Immunogenicity and Safety Trial in Young and Adult Women With GSK Biologicals' HPV-16/18
Condition: Infections, Papillomavirus
Intervention: Cervarix
Intervention description: Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 667.0
Sex: Female
Minimum age: 15 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HPV Vaccine Safety

Summary:

      Infection with human papillomavirus (HPV) has been clearly established as the central cause
      of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the
      uterus or womb). This infection may go away by itself, but if it does not go away (this is
      called persistent infection), it can lead in women over a long period of time to cancer of
      the cervix. This study will evaluate the immunogenicity and safety of GSK Biologicals
      HPV-16/18 vaccine over 12 months, in women up to 55 years of age at study start.
      Approximately 660 study subjects will receive the HPV vaccine administered intramuscularly
      according to a 0-1-6 month schedule. The study will be extended to assess long-term safety
      and immunogenicity of the HPV-16/18 vaccine.
    

Eligibility criteria:

        Inclusion criteria for primary study:

          -  A woman who the investigator believes that she and/or her parents/legally acceptable
             representative can and will comply with the requirements of the protocol.

          -  A woman between, and including, 15 and 55 years of age at the time of the first
             vaccination.

          -  Written informed consent obtained from the subject prior to enrolment (for subjects
             below the legal age of consent, written informed consent must be obtained from a
             parent or legally acceptable representative and, in addition, the subject should sign
             and personally date a written informed assent).

          -  Free of obvious health problems.

          -  Subject must have a negative urine pregnancy test.

          -  Subject must be of non-childbearing potential or, if of childbearing potential, she
             must be abstinent or must be using adequate contraceptive precautions for 30 days
             prior to vaccination and must agree to continue such precautions for two months after
             completion of the vaccination series. Subjects who reach menarche during the study and
             therefore become of childbearing potential must agree to follow the same precautions

        Inclusion criteria for extension studies

          -  A female who enrolled in the primary study and received three doses of vaccine.

          -  Written informed consent obtained from the subject prior to enrolment (for subjects
             below the legal age of consent, written informed consent must be obtained from a
             parent or legally acceptable representative and, in addition, the subject must sign
             and personally date a written informed assent).

        Exclusion criteria for primary study:

          -  Pregnant or breastfeeding.

          -  A woman planning to become pregnant, likely to become pregnant (as determined by the
             investigator) or planning to discontinue contraceptive precautions during the study
             period, up to two months after the last vaccine dose.

          -  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
             during the study period (up to Month 12).

          -  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 before and 30 days after 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.

          -  Previous administration of components of the investigational vaccine

          -  Previous vaccination against HPV.

          -  Any medically diagnosed or suspected 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 vaccine.

          -  Hypersensitivity to latex.

          -  Known acute or chronic, clinically significant neurologic, hepatic or renal functional
             abnormality, as determined by previous physical examination or laboratory tests.

          -  History of chronic condition(s) requiring treatment.

          -  Administration of immunoglobulins and/or any blood product within 3 months preceding
             the first dose of study vaccine or planned administration during the study period.
             Enrolment will be deferred until the subject is outside of specified window.

          -  Acute disease at the time of enrolment.

        Exclusion criteria for extension studies

          -  Use of any investigational or non-registered product (drug or vaccine) or planned use
             during the study period.

          -  Concurrently participating in another clinical study, at any time during the study
             period, 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 occurring
             less than 3 months prior to blood sampling.

          -  Administration of immunoglobulins and/or any blood products within the three months
             preceding blood sampling.