Human Papilloma Virus Vaccine Immunogenicity and Safety Trial in Young Adult Women With GSK Bio's Novel HPV Vaccine.
Condition: Infections, Papillomavirus
Intervention: HPV 16/18 L1 AS04; HPV-16/18/31/45 L1 AS04 Formulation 1; HPV-16/18/31/45 L1 AS04 Formulation 2; HPV-16/18/31/45 L1 AS04 Formulation 3; HPV-16/18/31/45 L1 AS04 Formulation 4; HPV-16/18/31/45 L1 AS04 Formulation 5; HPV-16/18/31/45 L1 AS04 Formulation 6
Intervention description: 3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.; 3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.; 3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.; 3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.; 3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.; 3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.; 3 doses of 0.6 mL supplied as a liquid in individual pre-filled syringes administered intramuscularly in the deltoid muscle of the non-dominant arm, at Day 0, Month 1 and Month 6.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: This study was performed in a double-blinded manner. Blinding was maintained for all subjects and investigators and their study staff participating in this study with regard to the individual subject treatment (vaccine treatment) assignments allocated in this study.
GSK personnel directly involved in the conduct of this study were also blinded to the subjects' treatment assignments.
Enrollment: 383.0
Sex: Female
Minimum age: 18 Years
Maximum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Human Papilloma viruses (HPV) are viruses that cause infections of the skin and genitals in
      men and women. Several types of HPV infection are transmitted by sexual activity and, in
      women, can infect the cervix (part of the uterus or womb). This infection, if it persists,
      can lead over a long period of time to cancer of the cervix in women. In collaboration with
      MedImmune Inc., GlaxoSmithKline Biologicals has developed a HPV vaccine against the oncogenic
      types HPV-16 and HPV-18 formulated with the adjuvant AS04. GSK Biologicals is also evaluating
      novel HPV vaccine formulations.This study will evaluate the immunogenicity and safety of a
      novel GSK Biologicals HPV vaccine in women 18-25 years of age at study start. Approximately
      376 study subjects will receive the novel HPV vaccine or the control vaccine administered
      intramuscularly according to a 0-1-6 month schedule.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A woman between, and including, 18 and 25 years of age at the time of the first
             vaccination

          -  Written informed consent from the subject prior to enrolment

          -  Subject must be free of obvious health problems

          -  Subject must be of non-childbearing potential and have had no more than 6 lifetime
             sexual partners

        Exclusion Criteria:

          -  Pregnant or breastfeeding

          -  A woman planning to become pregnant or planning to discontinue contraceptive
             precautions during approximately the first nine months of the study (Month 0-8)

          -  Known acute or chronic, clinically significant pulmonary, cardiovascular, neurologic,
             hepatic or renal functional abnormality

          -  History of chronic condition(s) requiring treatment such as cancer, chronic hepatitis
             or kidney disease(s), diabetes, or autoimmune disease

          -  Previous vaccination against human papillomavirus (HPV)