Evaluation of Safety and Immunogenicity of Co-administering HPV Vaccine With Other Vaccines in Healthy Female Subjects
Condition: Infections, Papillomavirus
Intervention: Different formulations of GSK Biologicals' HPV vaccine (580299); Menactra TM; Boostrix TM
Intervention description: Three doses of vaccine administered intramuscularly, with the second and third dose given one month and six months after the first dose respectively; One dose of vaccine administered intramuscularly; One dose of vaccine administered intramuscularly
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1330.0
Sex: Female
Minimum age: 11 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HPV; HPV, diptheria, pertussis, tetanus, meningitis

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/adolescents
      platform. Therefore, this Phase 3b study is designed to evaluate the safety and
      immunogenicity of co-administering Boostrix and/or Menactra with GSK Biologicals' HPV vaccine
      (580299) as compared to the administration of any of the vaccines alone.

      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 between, and including, 11 and 18 years of age at the time of the first
             vaccination.

          -  Written informed consent obtained from parents/legally acceptable representative of
             the subject and written informed assent obtained from the subject if the subject is
             less than 18 years of age, or written informed consent obtained from the subject if
             the subject is 18 years of age.

          -  Healthy subjects, as established by medical history and history-directed physical
             examination, before entering into the study.

          -  Previously completed routine childhood vaccinations against diphtheria, tetanus and
             pertussis diseases, according to the recommended vaccination schedule at the time.

          -  Subjects must have a negative urine pregnancy test.

          -  Subjects of childbearing potential at the time of study entry are required to be
             abstinent or use adequate contraceptive precautions for 30 days prior to vaccination.
             Subjects also are required to agree to continue such precautions for two months after
             completion of the vaccination series. Female subjects who reach menarche (began
             menstruating) during the study and therefore become of child-bearing potential are
             required to agree to follow the same precautions.

        Exclusion Criteria:

          -  Use of any investigational or non-registered product other than the study vaccine
             within 30 days preceding the first dose of study vaccine, or planned use during the
             study period.

          -  Concurrently participating in another clinical study, at any time during the study
             period (up to the Month 12/13 visit), in which the subject has been or will be exposed
             to an investigational or a non-investigational product.

          -  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. 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.

          -  A woman 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

          -  Administration of a pre-school booster of diphtheria, tetanus, pertussis vaccine
             within the previous five years.

          -  Administration of a diphtheria-tetanus booster or tetanus-diphteria-acellular
             pertussis (Tdap) vaccine within the previous five years.

          -  Previous vaccination against Neisseria meningitidis.

          -  Hypersensitivity to latex.

          -  Cancer or autoimmune disease under treatment.

          -  History of allergic disease or reactions likely to be exacerbated by any component of
             the vaccine or following any other tetanus toxoid, diphtheria toxoid or
             pertussis-containing vaccine.

          -  History of encephalopathy within seven days of administration of a previous dose of
             pertussis vaccine that is not attributable to another identifiable cause.

          -  Progressive neurologic disorder, uncontrolled epilepsy or progressive encephalopathy.

          -  Temperature of >= 105°F within 48 hours of receipt of a prior dose of diphteria-
             tetanu-pertussis (DTP) vaccine, not due to another identifiable cause.

          -  Collapse or shock-like state within 48 hours of receipt of a prior dose of DTP
             vaccine.

          -  Seizures with or without fever within three days of a prior dose of DTP vaccine.

          -  Severe Arthus-type hypersensitivity reactions following a prior dose of tetanus toxoid
             within the previous 10 years.

          -  Previous history of Guillain-Barré syndrome.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition

          -  Acute disease at the time of enrolment. All vaccines can be administered to persons
             with a minor illness

          -  Administration of immunoglobulins and/or any blood products within the 3 months
             preceding the first dose of study vaccine or planned administration during the study
             period.