A Single Centre Study to Evaluate the Safety and Immunogenicity of the Human Papillomavirus Vaccine (GSK-580299) in Chinese Females
Condition: Infections, Papillomavirus
MeSH terms: Infections
Intervention: GSK580299 (Cervarix™ , HPV -16/18 L1 VLP AS04 vaccine)
Intervention description: Intramuscular injection, 3 doses
Intervention MeSH terms: Vaccines
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: Female
Minimum age: 15 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HPV vaccine,; Cervical cancer; Human papillomavirus infection,

Summary:

      A phase I, open label, single-centre study to evaluate the safety and immunogenicity of
      GlaxoSmithKline Biologicals' HPV -16/18 L1 VLP AS04 vaccine (GSK 580299, Cervarix TM),
      administered intramuscularly according to a 0, 1, 6-month schedule in healthy Chinese female
      subjects aged 15 - 45 years.

      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 believes that they can and will comply with the
             requirements of the protocol should be enrolled in the study.

          -  A female of Chinese origin, residing in China, aged between 15 - 45 years (inclusive)
             at the time of the first vaccination.

          -  Written informed consent obtained from the subject. For subjects below the legal age
             of consent, written informed consent must be obtained from the subject's parent or
             Legally Acceptable Representative (LAR), and written informed assent must be obtained
             from the subject.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

          -  Subjects must have a negative urine pregnancy test.

          -  Subjects must be of non-childbearing potential, or if the subject is of childbearing
             potential, she must be abstinent or must be using adequate contraception for 30 days
             prior to vaccination and continue 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 within 30 days preceding the first dose of study vaccine, or planned use
             during the study period.

          -  Pregnant or breastfeeding.

          -  Planning to become pregnant or likely to become pregnant

          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs within six months prior to the first vaccine dose.

          -  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.

          -  Planned administration/administration of a vaccine not foreseen by the study protocol
             within 30 days preceding and 30 days after the first dose of vaccine. Administration
             of some routine vaccines up to 8 days before the first dose of study vaccine is
             allowed.

          -  Previous administration of components of the investigational vaccine.

          -  Previous vaccination against HPV or planned administration of any HPV vaccine other
             than that foreseen by the study protocol during the study period.

          -  Any confirmed or suspected immunosuppressive or 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.

          -  Major congenital defects or serious chronic illness.

          -  History of any neurologic disorders or seizures.

          -  Known acute or chronic, clinically significant system conditions.

          -  Cancer or autoimmune disease under treatment.

          -  Acute disease at the time of enrolment.

          -  History of chronic alcohol consumption and/or drug abuse.