Evaluation of Safety and Immunogenicity of Co-administering Human Papillomavirus (HPV) Vaccine With Other Vaccines in Healthy Female Subjects
Condition: Infections, Papillomavirus
Intervention: Boostrix ® Polio; GSK Biologicals' HPV-16/18 L1 AS04 vaccine (Cervarix TM)
Intervention description: One dose of vaccine administered intramuscularly; Three doses of vaccine administered intramuscularly, with the second and third dose give one month and six months after the first dose respectively
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 751.0
Sex: Female
Minimum age: 10 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Human Papillomavirus

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 IIIb study is designed to evaluate the safety and
      immunogenicity of co-administering Boostrix polio (dTpa-IPV) with GSK Biologicals'
      (580299)HPV-16/18 L1 AS04 vaccine (Cervarix TM) as compared to the administration of either
      vaccine 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 and their parents/legally acceptable
             representatives can, and will, comply with the requirements of the protocol should be
             enrolled in the study.

          -  A female between, and including, 10 and 18 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 legal age of consent, written informed consent
             obtained from the subject's parent/LAR, and written informed assent must be obtained
             from the subject.

          -  Healthy subjects, as established by medical history and history-directed physical
             examination, before entering into the study.

          -  Previously completed routine childhood vaccinations according to the recommended
             vaccination schedule at the time.

          -  Subjects must have a negative urine pregnancy test.

          -  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 must agree to continue such precautions for two months
             after completion of the vaccination series. Subjects who reach menarche during the
             study, and therefore become of childbearing potential, must agree to follow the same
             precautions.

        Exclusion Criteria:

          -  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 (up to Month 12/13).

          -  Concurrently participating in another clinical study, at any time during the study
             period, 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 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 diphtheria, tetanus, pertussis (DTP) vaccine, diphtheria-tetanus
             (Td) booster or dTpa vaccine within the previous five years.

          -  Administration of a pre-school booster of Oral Polio Vaccine (OPV) or Inactivated
             Polio Virus (IPV) vaccine (4 or 5th dose) within the previous five years.

          -  Hypersensitivity to latex.

          -  Known acute or chronic, clinically significant neurologic, hepatic or renal functional
             abnormality or thrombocytopenia, 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.

          -  History of encephalopathy within seven days of administration of a previous dose of
             pertussis vaccine that is not attributable to another identifiable cause.

          -  Temperature of >=40°C within 48 hours of receipt of a prior dose of DTP vaccine (DTPw
             and/or DTPa), not due to another identifiable cause.

          -  Collapse or shock-like state within 48 hours of receipt of a prior dose of DTP vaccine
             (DTPw and/or DTPa).

          -  Seizures with or without fever within three days of a prior dose of DTP vaccine
             (Diphtheria, Tetanus, whole cell Pertussis vaccine DTPw and/or Diphtheria, Tetanus,
             acellular Pertussis vaccine DTPa).

          -  Persistent, inconsolable crying lasting >=3 hours, occurring within 48 hours of a
             prior dose of DTP vaccine (DTPw and/or DTPa).

          -  Severe Arthus-type hypersensitivity reactions following a prior dose of tetanus toxoid
             within the previous 10 years.

          -  Known exposure to diphtheria or household exposure to pertussis within 30 days before
             (i.e., Day 0-29) vaccination with Diphtheria, Tetanus, acellular Pertussis and
             inactivated polio virus vaccine (dTpa-IPV).

          -  Diphtheria and/or tetanus and/or pertussis and/or polio diagnosed within 30 days
             before (i.e., Day 0-29) vaccination with dTpa-IPV.

          -  Presence of a contra-indication to vaccination according to the product leaflet of the
             commercially available dTpa-IPV vaccine.

          -  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 3 months
             preceding the first dose of study vaccine or planned administration during the study
             period. Enrolment will be postponed until the subject is outside the specified window.