Human Papilloma Virus (HPV) Vaccine Trial in Young Adolescent Women With GlaxoSmithKline Biologicals' (GSK Bio) HPV-16/18 Vaccine
Condition: Cervical Intraepithelial Neoplasia; Papillomavirus Infection
MeSH terms: Papillomavirus Infections; Neoplasms; Uterine Cervical Dysplasia
Intervention: GSK Biologicals' HPV-16/18 Vaccine (Cervarix™); Havrix™
Intervention description: Three doses of vaccine administrerd intramuscularly according to 0, 1, 6 month schedule; Three doses of vaccine administrerd intramuscularly according to 0, 1, 6 month schedule.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1245.0
Sex: Female
Minimum age: 10 Years
Maximum age: 14 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Prophylaxis HPV-16/18 infections and cervical neoplasia

Summary:

      This protocol posting deals with objectives & outcome measures of the extension phase up to
      Month 48. The objective of the extension study is to evaluate the long-term immunogenicity of
      the HPV 16/18 L1 VLP AS04 vaccine (for all subjects in the HPV Vaccine Group) by
      enzyme-linked immunosorbent assay (ELISA). The objectives & outcome measures of the primary
      phase are presented in a separate protocol posting (NCT00196924).

      The long-term follow-up study will be blinded until the primary study is unblinded and will
      be open for all visits subsequent to unblinding of primary study HPV-013 (NCT00196924).
      During the open phase, only subjects who received the HPV-16/18 VLP/AS04 vaccine during the
      primary study will continue their participation in the follow-up study until Month 48.
      Subjects in the Control group (Havrix®) will attend one further visit as their last study
      visit.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A female who enrolled in the immunological subset of the 580299-013 study, received
             the three doses of vaccine/control according to the treatment allocation and completed
             the 580299-013 study.

          -  Written informed assent obtained from the subject and written informed consent
             obtained from a parent or legally acceptable representative of the subject.

        Exclusion Criteria:

          -  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).

          -  Use of any investigational or non-registered product (drug or vaccine) or planned use
             during the study period.

          -  Chronic administration of immunosuppressants or other immune-modifying drugs occurring
             less than 3 months prior to blood sampling.

          -  Administration of immunoglobulins and/or any blood products within the 3 months
             preceding blood sampling.