A Study of V503, a 9-valent Human Papillomavirus (9vHPV) Vaccine in Females 12-26 Years of Age Who Have Previously Received GARDASIL™ (V503-006)
Condition: Cervical Cancers; Vulvar Cancers; Vaginal Cancers; Genital Warts
MeSH terms: Condylomata Acuminata; Uterine Cervical Neoplasms; Vulvar Neoplasms; Vaginal Neoplasms
Intervention: V503; Placebo to V503
Intervention description: V503 (9vHPV) vaccine given as a 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study or the Study Extension; Placebo to V503 (saline) given as a 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 924.0
Sex: Female
Minimum age: 12 Years
Maximum age: 26 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cervical cancer; Genital warts; Human papillomavirus vaccine; GARDASIL™

Summary:

      This study will evaluate whether V503 (9vHPV vaccine), is well tolerated in girls and women
      between 12 and 26 years old who have previously been vaccinated with GARDASIL™. Participants
      will receive vaccination with 9vHPV vaccine or placebo on Day 1, Month 2, and Month 6 of the
      Base Study. Participants who receive placebo in the Base Study will be eligible to receive
      vaccination with 9vHPV vaccine on Day 1, Month 2, and Month 6 of the Extension Study.
    

Eligibility criteria:

        Inclusion Criteria:

        Participants Age 12 to 15 Years:

          -  Participant is in good health

          -  Parent/legal guardian and participant agree to provide study personnel with a primary
             telephone number for follow-up

          -  Participant received a 3-dose regimen of marketed GARDASIL™ within a 1 year period and
             the last dose of GARDASIL™ was at least 1 year from study day 1

          -  Participant has not received any other HPV vaccine

          -  Participant is not yet sexually active

        Participants Age 16 to 26 Years:

          -  Participant is in good health

          -  Participant agrees to provide a primary telephone number for follow-up

          -  Participant received a 3-dose regimen of marketed GARDASIL™ within a 1 year period and
             the last dose of GARDASIL™ was at least 1 year from study day 1

          -  Participant has not received any other HPV vaccine

          -  Participant has never had Papanicolaou (Pap) testing or has only had normal results

          -  Participant has a history of 0 to 4 lifetime sexual partners at enrollment

        Exclusion Criteria:

        All participants:

          -  Participant has a history of severe allergic reaction that required medical
             intervention

          -  Participant has any disorder that would contraindicate intramuscular injections

          -  Participant is pregnant

          -  Participant is immunocompromised or has an autoimmune condition

          -  Participant has had a splenectomy

          -  Participant has received any immune globulin product or blood-derived product

          -  Participant has participated in a HPV vaccine clinical trial

        Participants Age 16 to 26 Only:

          -  Participant expects to donate eggs during the study

          -  Participant has a history of abnormal cervical biopsy result

          -  Participant has a history of HPV-related external genital lesions, external genital
             cancer, HPV-related vaginal lesions, or vaginal cancer