Multivalent HPV (Human Papillomavirus) Vaccine Study in 16- to 26-Year Old Men and Women (V503-003)

A Phase III Clinical Trial to Study the Tolerability and Immunogenicity of 9vHPV (V503), a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, in 16- to 26-Year-Old Men and 16- to 26-Year-Old Women

This study is designed to evaluate the immunogenicity and tolerability of 9vHPV (9-valent HPV vaccine, V503) in 16- to 26-year old men and women. The overall goal is to bridge 9vHPV efficacy findings in young women to young men based on the demonstration of similar immunogenicity and safety profiles. The primary hypothesis is that 9vHPV induces antibody responses at 4 weeks postdose 3 in heterosexual males that are non-inferior to antibody responses in young women.

Study participants will be administered a 3-dose regimen of 9vHPV. They will be assessed for immunogenicity 1 month following completion of vaccination. All participants will be followed for safety for a total of 12 months.

Inclusion Criteria:

• Good physical health
• Has never had Papanicolaou testing (Pap, cervical or anal) or has only had normal Pap test results
• Other inclusion criteria will be discussed with the investigator

Exclusion Criteria:

• History of severe allergic reaction that required medical intervention
• Currently enrolled in a clinical trial
• If participant is female, pregnant
• Currently immunocompromised or having received immunosuppressive therapy in the last year
• Positive test for HPV
• History of HPV-related external genital lesions or HPV-related anal lesions or anal cancer
• If participant is female, history of abnormal cervical biopsy results
• Other exclusion criteria will be discussed with the investigator