Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Human Papillomavirus (HPV) Vaccine (GSK-580299) and Merck's Gardasil Vaccine When Administered According to Alternative 2-dose Schedules in 9-14 Year Old Females
Condition: Infections, Papillomavirus
Intervention: Cervarix; Gardasil; Placebo
Intervention description: 2 doses of 0.5 mL supplied as a liquid in individual pre-filled syringes to be administered intramuscularly in the deltoid muscle of the non-dominant arm at Day 0 and Month 6.; 2 or 3 doses of 0.5 mL supplied as a liquid in individual pre-filled syringes or vials to be administered intramuscularly in the deltoid muscle of the non-dominant arm at Day 0 and Month 6 (Gardasil 2 dose Group) or at Day 0, Month 2 and Month 6 (Gardasil 3 dose Group), respectively.; 2 doses of 0.5 mL supplied as a liquid in individual pre-filled syringes to be administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 2 to maintain blinding.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1079.0
Sex: Female
Minimum age: 9 Years
Maximum age: 14 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Human papillomavirus; Safety; HPV vaccine; Immune response

Summary:

      The purpose of this study is to evaluate the immunogenicity and the safety of Cervarix
      administered according to a 2-dose schedule at 0, 6 months compared to Gardasil, administered
      according to a 2-dose schedule at 0, 6 months or the standard 3-dose schedule of 0, 2, 6
      months in 9-14 years old healthy females.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes can and will comply with the requirements of
             the protocol 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 14 years of age at the time of the first
             vaccination.

          -  Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to
             enrolment in the study. In addition, if capable, the subject should sign and
             personally date a written informed assent.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

          -  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 treatment period
                  and for two months after completion of the vaccination series.

        Exclusion Criteria:

          -  Pregnant or breastfeeding.

          -  A woman planning to become pregnant, likely to become pregnant (as determined by the
             investigator) or planning to discontinue contraceptive precautions during the
             vaccination phase of the study, i.e. up to two months after the last vaccine dose.

          -  Previous vaccination against HPV or planned administration of another HPV vaccine
             during the study other than those foreseen in the protocol.

          -  Child in care.

          -  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 (up to Month 36).

          -  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 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 (pharmaceutical product or device).

          -  Previous administration of vaccine components.

          -  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.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

          -  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.

          -  Drug and/or alcohol abuse.