Immunogenicity of GlaxoSmithKline Biological's Human Papillomavirus (HPV) Vaccine (580299) Versus Merck's Gardasil® in Healthy Females 18-45 Years of Age
Condition: Infections, Papillomavirus; Papillomavirus Vaccines
MeSH terms: Infections
Intervention: GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM); Gardasil ® (Merck & Co. Inc); Placebo; Placebo
Intervention description: Three doses administered intramuscularly at months 0, 1 and 6; Three doses administered intramuscularly at months 0, 2 and 6; One dose administered intramuscularly at month 1 to maintain blinding; One dose administered intramuscularly 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: 1106.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Vaccines; Cervical cancer; Immunogenicity; Humans; Safety; Viral infections; Human papillomavirus (HPV); Comparative study; Human papillomavirus vaccine; Adults

Summary:

      HPV infection has been established as a necessary cause of cervical cancer. GSK Biologicals
      has developed an HPV-16/18 L1 VLP AS04 vaccine (Cervarix TM) which targets the 2 most common
      oncogenic HPV types (HPV-16 and HPV-18), found in > 70%, approximately, of all cervical
      cancers. Recently, Merck's HPV vaccine Gardasil® [quadrivalent human papillomavirus
      (HPV-6,11,16,18 L1 VLP) recombinant vaccine] has been approved by the FDA for prevention of
      genital tract cancers and pre-cancers and genital warts in females. Although the GSK HPV
      vaccine and Gardasil® have different compositions and are expected to have different efficacy
      profiles, each vaccine targets prevention of HPV-16 and 18 genital tract cancers and
      pre-cancers. Therefore, a comparison of the immunogenicity of the two vaccines is warranted.
      This Phase 3b study is designed to compare the immunogenicity of the GSK vaccine (HPV-16/18)
      to Gardasil® in healthy adult females 18-45 years of age.

      The Protocol Posting has been updated as the study will be extended by 3 additional years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A woman whom the investigator believes that she or her legally acceptable
             representative (in the event that the subject is illiterate) can and will comply with
             the requirements of the protocol (e.g., completion of the diary cards, return for
             follow-up visits).

          -  A woman between and including 18 and 45 years of age at the time of the first
             vaccination.

          -  Written informed consent must be obtained from the subject prior to enrollment.

          -  Subject must be free of obvious health problems as established by medical history and
             history-directed clinical examination before entering into the study.

          -  Subject must have a negative urine pregnancy test.

          -  Subject must be of non-childbearing potential, or if she is of child bearing
             potential, she must practice adequate contraception for 30 days prior to vaccination,
             have a negative pregnancy test and continue such precautions for 2 months after
             completion of the vaccination series.

          -  Subject must have an intact cervix.

        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 60.

          -  Chronic administration (defined as more than 14 days) of immunosuppressants or other
             immune-modifying drugs within six months prior to the first vaccine dose or planned
             administration during the study period up to Month 60.

          -  Planned administration/administration of a vaccine not foreseen by the study protocol
             within 30 days before and 30 days after (i.e. days 0-29) each dose of vaccine.
             Administration of routine vaccines up to 8 days before each dose of study vaccine is
             allowed. Enrolment will be deferred until the subject is outside of specified window.

          -  Pregnant or breastfeeding. Women must be at least 3 months post-pregnancy and not
             breastfeeding to enter the study.

          -  A woman planning to become pregnant or planning to discontinue contraceptive
             precautions during approximately the first eight months of the study (Months 0-8).

          -  Previous administration of components of the investigational vaccine

          -  Previous or planned vaccination against HPV outside of this protocol.

          -  Any medically diagnosed or suspected immunodeficient condition based on medical
             history and physical examination.

          -  History of allergic disease, suspected allergy or reactions likely to be exacerbated
             by any component of the study vaccines.

          -  Hypersensitivity to latex.

          -  Known acute or chronic, clinically significant pulmonary, cardiovascular, neurologic,
             hepatic or renal functional abnormality, as determined by previous physical
             examination or laboratory tests.

          -  History of significant medical conditions and currently under treatment.

          -  Received immunoglobulins and/or blood product within 90 days preceding enrolment or
             planned administration during the study period up to Month 60. Enrollment will be
             deferred until the subject is outside of specified window.

          -  Acute disease at the time of enrolment. Enrollment will be deferred until condition is
             resolved. All vaccines can be administered to persons with a minor illness

          -  Heavy bleeding (menstruation or other) or heavy vaginal discharge in which a pelvic
             exam cannot be performed. Enrollment will be deferred until condition is resolved
             according to investigator's medical judgement.