Extension Study of the Efficacy of the GSK 580299 Vaccine in Japanese Women Vaccinated in the Primary NCT00316693 Study
Condition: Infections, Papillomavirus
MeSH terms: Uterine Cervical Dysplasia
Intervention: Liquid-based cytology (LBC) sampling; Blood sampling
Intervention description: LBC samples will be collected at Months 36 and 48 for cytology and HPV DNA testing (by PCR); Blood samples will be collected at Months 36 and 48 for antibody determination
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 752.0
Sex: Female
Minimum age: 20 Years
Maximum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HPV vaccine; cervical intraepithelial neoplasia (CIN); including new onset of autoimmune disease [NOAD]); new onset of chronic disease (NOCD); medically significant condition (MSC)

Summary:

      This extension study is conducted to assess the efficacy of the GSK 580299 vaccine against
      cervical intraepithelial neoplasia (CIN) lesions, cervical cancer and cytological
      abnormalities associated with human papillomavirus (HPV)-16 and/or HPV-18 or other oncogenic
      HPV types for an additional two years. All subjects who participated in the primary
      vaccination study NCT00316693 and who confirmed their interest in participating in a long
      term follow up study will therefore be invited to be followed for up to 48 months after
      administration of the first dose of vaccine. In addition, safety and persistence of the
      humoral immune response will be evaluated in this study.

      This protocol posting deals with objectives & outcome measures of the extension phase at
      Months 36 and 48. The objectives & outcome measures of the primary phase are presented in a
      separate protocol posting (NCT number = NCT00316693).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that they can and will comply with the
             requirements of the protocol;

          -  Written informed consent obtained from the subject prior to enrolment in the extension
             study;

          -  A subject previously vaccinated in the NCT00316693 study.

          -  Subjects who showed, at the last NCT00316693 study visit (at Month 24) willingness to
             participate in this extension study.

        Exclusion Criteria:

          -  Use of any HPV vaccine other than the one administered in the NCT00316693 study;

          -  Use of any investigational or non-registered product other than the study vaccine
             since last NCT00316693 study visit, or planned use during the study period;

          -  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;

          -  Subjects who were diagnosed high grade or missing cytology at Month 0 in the
             NCT00316693 study;

          -  Pregnant females and females who were pregnant less than 3 months ago.