Human Papillomavirus (HPV) Vaccine (Cervarix TM) Efficacy, Immunogenicity & Safety Trial in Adult Japanese Women With GSK Biologicals HPV-16/18 Vaccine
Condition: Infections, Papillomavirus
Intervention: HPV-16/18 vaccine (Cervarix™); Aimmugen™
Intervention description: Intramuscular injection, 3 doses; Intramuscular injection, 3 doses
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 1046.0
Sex: Female
Minimum age: 20 Years
Maximum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HPV Vaccine Efficacy

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 efficacy in prevention of persistent HPV-16 or
      HPV-18 cervical infection lasting at least 6 months, the immunogenicity and safety of GSK
      Biologicals HPV-16/18 vaccine (Cervarix TM ) over 24 months in Japanese adult women aged 20 -
      25 years of age at study start. Approximately 1000 study subjects will either receive the HPV
      vaccine or a control vaccine (Hepatitis A vaccine) administered intramuscularly according to
      a 0-1-6 month schedule.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Eligibility criteria:

        Inclusion criteria :

          -  Subjects who the investigator/co-investigator believes that they can and will comply
             with the requirements of the protocol should be enrolled in the study.

          -  A Japanese female subject between, and including, 20 and 25 years of age at the time
             of the first vaccination.

          -  Written informed consent obtained from the subject prior to enrolment.

          -  Healthy subjects as established by medical history and history-oriented clinical
             examination before entering into the study.

          -  Subjects must have a negative urine pregnancy test.

          -  Subjects must be of non-childbearing potential, she must be abstinent or have used
             adequate contraceptive precautions for 30 days prior to vaccination, have a negative
             pregnancy test and must agree to continue such precautions for two months after
             completion of the vaccination series.

          -  Subject must have an intact cervix

        Exclusion criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine/control within 30 days preceding the first dose of study
             vaccine/control, or planned use during the study period.

          -  Pregnant or breastfeeding women. Women must be at least 3 months post-pregnancy and
             not breastfeeding to enter the study.

          -  A women planning to become pregnant, likely to become pregnant or planning to
             discontinue contraceptive precautions during the study period, up to 2 months after
             the last vaccine dose

          -  previous administration of components of the investigational vaccine

          -  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 the first dose of vaccine. Routine vaccines
             may be allowed up to 8 days before the first dose of study vaccine.

          -  Previous vaccination against HPV.

          -  History of vaccination against hepatitis A or a known clinical history of hepatitis A
             disease

          -  Administration of immunoglobulin and/or any blood products within the three months
             preceding the first dose of study vaccine or planned administration during the study
             period.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition based on
             medical history and physical examination

          -  History of allergic disease 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 having had colposcopy or has planned a colposcopy to evaluate an abnormal
             cervical cytology (Pap smear) test.

          -  Heavy bleeding or heavy vaginal discharge such that a pelvic examination can not be
             performed

          -  Acute disease at the time of enrolment.

          -  Oral temperature >= 37.5°C / axillary temperature > 37.5°C.

          -  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).