Human Papilloma Virus (HPV) Vaccine Efficacy Trial Against Cervical Pre-cancer in Young Adults With GlaxoSmithKline (GSK) Biologicals HPV-16/18
Condition: Infections, Papillomavirus
MeSH terms: Infections
Intervention: Cervarix™; Havrix™-based investigational formulation
Intervention description: Intramuscular injection, 3 doses; Intramuscular injection, 3 doses
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 18729.0
Sex: Female
Minimum age: 15 Years
Maximum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and
      genitals in men and women. Several types of HPV infection are transmitted by sexual activity
      and, in women, can infect the cervix (part of the uterus or womb). This infection often goes
      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. If a woman is not infected by
      HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the
      efficacy of GSK Biologicals HPV 16/18 VLP/AS04 vaccine to prevent infection associated
      cervical pre-cancer and vaccine with HPV 16 or 18 and the vaccine safety, over 48 months, in
      young adolescents and women of 15/25 years of age at study start. Approximately 18.000 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:

          -  A woman whom the investigator believes that she and/or her parents/legally acceptable
             representative can and will comply with the requirements of the protocol (e.g.,
             completion of the diary cards, return for follow-up visits).

          -  A woman between, and including, 15 and 25 years of age at the time of the first
             vaccination.

          -  Written informed consent must be obtained from the subject prior to enrollment (for
             subjects below the legal age of consent, written informed consent must be obtained
             from a parent or legal guardian of the subject and, in addition, the subject should
             sign and personally date a written informed assent).

          -  Subject must be free of obvious health problems as established by medical history and
             clinical examination before entering into the study.

          -  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 the first vaccination and must agree to continue such precautions for two
             months after completion of the vaccination series.

          -  Has had no more than 6 lifetime sexual partners prior to enrollment. This criterion
             may not be applicable in subjects less than 18 years of age, according to local
             regulatory/ethical requirements.

          -  Subject must have intact cervix.

        Exclusion Criteria:

          -  Pregnant or breastfeeding. Women must be at least 3 months post-pregnancy and not
             breastfeeding to enter the study.

          -  A woman planning to become pregnant or planning to discontinue contraceptive
             precautions during approximately the first nine months of the study (Months 0-8).

          -  Previous administration of components of the investigational vaccine.

          -  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 (i.e. days 0-29) each dose of vaccine.
             Administration of some routine vaccines up to 8 days before each dose of study vaccine
             is allowed. Enrolment will be deferred until the subject is outside of specified
             window.

          -  Previous vaccination against human papillomavirus (HPV).

          -  History of vaccination against Hepatitis A or a known clinical history of Hepatitis A
             disease.

          -  History of having had colposcopy or has planned a colposcopy to evaluate an abnormal
             cervical cytology (Pap smear) test.

          -  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 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.

          -  History of chronic condition(s) requiring treatment.

          -  Received immunoglobulins and/or blood product within 90 days preceding enrollment.
             Enrollment will be deferred until the subject is outside of specified window.

          -  Acute disease at the time of enrolment.

          -  Heavy bleeding (menstruation or other) or heavy vaginal discharge in which a pelvic
             exam cannot be performed. Enrollment will be deferred until condition is resolved
             according to investigator's medical judgement.