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™
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 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