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)

A Phase III, Randomized, International, Placebo-Controlled, Double-Blind Clinical Trial to Study the Tolerability and Immunogenicity of V503, a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, Given to Females 12-26 Years of Age Who Have Previously Received GARDASIL™

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.

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