Evaluation of Safety and Immunogenicity of Co-administering Human Papillomavirus Vaccine With Another Vaccine in Healthy Female Subjects
Condition: Infections, Papillomavirus
MeSH terms: Infections
Intervention: Cervarix™; Twinrix ™ Paediatric
Intervention description: Three doses of vaccine administered intramuscularly with the second and third dose given one month and six months after the first dose; Three doses of vaccine administered intramuscularly with the second and third dose given one month and six months after the first dose
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 814.0
Sex: Female
Minimum age: 9 Years
Maximum age: 15 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Human papillomavirus infection,; cervical cancer; HPV vaccine,

Summary:

      Infection with human papillomavirus (HPV) has been clearly established as the central cause
      of cervical cancer. Vaccination of pre-teens and adolescents, ideally before sexual debut and
      thus before exposure to oncogenic HPV, is a rational strategy for prevention of cervical
      cancer, and so HPV vaccination could complement the existing pre-adolescent/adolescent
      vaccination programs. Therefore, this Phase IIIb study is designed to evaluate the safety and
      immunogenicity of co-administering a commercially available vaccine with GSK Biologicals'
      HPV-16/18 L1 AS04 (Cervarix ®) vaccine as compared to the administration of either vaccine
      alone. This Protocol Posting has been updated in order to comply with the FDA AA, Sept 2007.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that they and/or their legally acceptable
             representatives (LARs) can and will comply with the requirements of the protocol
             should be enrolled in the study.

          -  A female between, and including, 9 and 15 years of age (has not attained her 16th
             birthday) 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 the
             subject's 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 not be pregnant.

          -  Subjects must be of non-childbearing potential, or if the subject is of childbearing
             potential, she must be abstinent or use adequate contraception for 30 days prior to
             vaccination and must agree to 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 12).

          -  Concurrently participating in another clinical study, at any time during the study
             period (up to the Month 12 telephone contact), 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 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 each dose of vaccine(s). Administration of
             routine vaccines may be allowed up to 8 days before the first dose

          -  A subject planning to become pregnant, likely to become pregnant or planning to
             discontinue contraceptive precautions during the study period and up to two months
             after the last vaccine dose.

          -  Pregnant or breastfeeding women.

          -  Previous vaccination against HPV or planned administration of any HPV vaccine other
             than that foreseen by the study protocol during the study period.

          -  Previous administration of components of the investigational vaccine.

          -  Previous vaccination against hepatitis A or B planned administration of any hepatitis
             A or B vaccine other than that foreseen by the study protocol during the study period.

          -  History of hepatitis A or B infection.

          -  Known exposure to hepatitis A or B within the previous 6 weeks.

          -  Known acute or chronic, clinically significant neurologic, hepatic or renal functional
             abnormality, as determined by previous physical examination or laboratory tests.

          -  Cancer or autoimmune disease under treatment.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccines

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination

          -  Acute disease at the time of enrolment.

          -  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.