Evaluation of Immunogenicity and Safety of Two 2-dose Human Papillomavirus (HPV) Vaccine Schedules in 9-14 Year Old Girls
Condition: Infections, Papillomavirus
MeSH terms: Infections
Intervention: GSK Biologicals' HPV vaccine 580299
Intervention description: Subjects received 2 or 3 doses of HPV vaccine administered intramuscularly.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1447.0
Sex: Female
Minimum age: 9 Years
Maximum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HPV infection; Human Papillomavirus; Cervical cancer; HPV-16; HPV-18; vaccine

Summary:

      This study has been designed to evaluate the immunogenicity and safety of GSK Biologicals'
      HPV-16/18 vaccine when administered according to alternative 2-dose schedules (0,6 months and
      0,12 months) in healthy 9-14 year old females as compared to the standard 3-dose schedule
      (0,1,6 months) in 15-25 year old females.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes can and will comply with the requirements of
             the protocol or/ and subjects who the investigator believes their parent(s)/Legally
             Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the
             protocol

          -  A female between, and including, 9 and 25 years of age at the time of the first
             vaccination

          -  Written informed consent obtained from the subject/from the parent(s)/LAR(s) of the
             subject prior to enrolment in the study. In addition, subjects below the legal age of
             consent should sign and personally date a written informed assent form

          -  Healthy subjects

          -  Female subjects of non-childbearing potential may be enrolled in the study

          -  Female subjects of childbearing potential may be enrolled in the study, if the
             subject:

               -  has practiced adequate contraception for 30 days prior to vaccination, and

               -  has a negative pregnancy test on the day of vaccination, and

               -  has agreed to continue adequate contraception during the entire vaccination
                  period and up to two months after the last study vaccine dose

        Exclusion Criteria:

          -  Pregnant or breastfeeding

          -  A female planning to become pregnant, likely to become pregnant or planning to
             discontinue contraceptive precautions during the entire vaccination period and up to
             two months after the last study vaccine dose

          -  Previous vaccination against HPV or planned administration of another HPV vaccine
             during the study

          -  Child in care. A child in care is a child who has been placed under the control or
             protection of an agency, organisation, institution or entity by the courts, the
             government or a government body, acting in accordance with powers conferred on them by
             law or regulation. The definition of a child in care does not include a child who is
             adopted or has an appointed legal guardian.

          -  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

          -  Chronic administration of immunosuppressants or other immune-modifying drugs within
             six months prior to the first vaccine dose. History of allergic disease, suspected
             allergy or reactions likely to be exacerbated by any component of the study vaccines

          -  Cancer or autoimmune disease under treatment

          -  Planned administration/administration of a vaccine/product not foreseen by the study
             protocol within 30 days before each dose of vaccine. Administration of routine
             meningococcal, hepatitis B, hepatitis A, inactivated influenza, diphtheria/tetanus
             and/or diphtheria/tetanus-containing vaccine up to 8 days before each dose of study
             vaccine is allowed. Enrolment will be deferred until the subject is outside of
             specified window

          -  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

          -  Previous administration of MPL or AS04 adjuvant.

          -  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

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition

          -  Family history of congenital or hereditary immunodeficiency

          -  Major congenital defects or serious chronic illness

          -  Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal
             functional abnormality, as determined by physical examination or laboratory screening
             tests, which in the opinion of the investigator precludes administration of the study
             vaccine

          -  Acute disease and/or fever at the time of enrolment