Partially Blind Study to Evaluate Immunogenicity & Safety of GSK Bio's HPV Vaccine 580299 in Healthy Women Aged 9-25 Yrs
Condition: Infections, Papillomavirus
MeSH terms: Infections
Intervention: Cervarix; Placebo
Intervention description: Intramuscular injection, different dosing /schedule; Intramuscular injection, different dosing /schedule
Intervention MeSH terms: Vaccines
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 961.0
Sex: Female
Minimum age: 9 Years
Maximum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: viral infections; Human Papillomavirus (HPV) vaccine; safety; vaccine; immunogenicity; cervical cancer

Summary:

      Human Papillomavirus (HPV) infection has been established as a necessary cause of cervical
      cancer. GlaxoSmithKline (GSK) Biologicals has developed an HPV vaccine (580299) which targets
      the 2 most common oncogenic HPV types (HPV-16 and HPV-18), found in approximately 70% of all
      cervical cancers. In previous trials this vaccine has been found to be efficacious in the
      prevention of incident and persistent HPV-16/18 infections and associated cytological
      abnormalities and cervical dysplasia. In this partially-blind study, GSK Biologicals will
      evaluate the safety and immunogenicity of the HPV vaccine using an alternative schedule and
      an alternative dosing when administered in healthy young females aged 9 to 25 years, as
      compared to the standard HPV vaccine. The Protocol Posting has been updated in order to
      comply with the FDA Amendment Act, Sep 2007. The protocol posting has been updated following
      a protocol amendment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that they and/or their parents can and will
             comply with the requirements of the protocol should be enrolled in the study.

          -  A female subject between, and including, 9 and 25 years of age at the time of the
             first vaccination.

          -  Written informed consent/assent obtained from the subject prior to enrolment. For
             subjects above the legal age of consent, written informed consent must be obtained
             from the subject. For subjects below the legal age of consent, written informed
             consent from the subject's parents/legally acceptable representative, and written
             informed assent must be obtained from the subject.

          -  Healthy subjects as established by medical history and history-oriented clinical
             examination before entering into the study.

          -  Subject 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 two months after completion
             of the vaccination series.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccines within 30 days preceding the first dose of study vaccine, or planned
             use during the study period (up to Month 24).

          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs within six months prior to the first vaccine dose.

          -  Concurrently participating in another clinical study, at any time during the study
             period (up to Month 24), in which the subject has been or will be exposed to an
             investigational or a non-investigational product (pharmaceutical product or device).

          -  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. 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.

          -  Pregnant or breastfeeding female.

          -  A woman planning to become pregnant or planning to discontinue contraceptive
             precautions during the study period, up to two months after the last vaccine dose.

          -  Previous vaccination against HPV or planned administration of any HPV vaccine other
             than that foreseen by the study protocol during the study period (up to Month 24).

          -  Previous administration of components of the investigational vaccine.

          -  Cancer or autoimmune disease under treatment.

          -  Any medically diagnosed 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 vaccine.

          -  Hypersensitivity to latex.

          -  Acute disease at the time of enrolment.

          -  Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal
             functional abnormality, as determined by physical examination or laboratory tests.

          -  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 (up to Month 24).