Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004)

An Open-Label Phase III Clinical Trial to Study the Immunogenicity and Tolerability of GARDASIL®9 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Adult Women (27- to 45-Year-Olds) Compared to Young Adult Women (16 to 26 Year Olds)

This study will assess the safety and immunogenicity of GARDASIL®9 (V503) in 16- to 45-year-old women. The primary hypothesis of the study states that anti-HPV 16, 18, 31, 33, 45, 52, and 58 geometric mean titers (GMTs) at 4 weeks postdose 3 are non-inferior in adult women as compared with GMTs in young adult women.

Inclusion Criteria:

• good physical health

Exclusion Criteria:

• history of an abnormal Pap (Papanicolaou) test or abnormal cervical biopsy results
• history of HPV-related condition
• history of known prior vaccination with an HPV vaccine
• pregnant
• user of recreational or illicit drugs
• history of severe allergic reaction, including known allergy to any vaccine component
• immunocompromised
• history of certain medications or is currently taking or has taken certain medications (details will be discussed at the time of consent)
• has thrombocytopenia or other coagulation disorder
• concurrently enrolled in a clinical study of investigational agent