Post-Licensure Study of the Safety of GARDASIL™ in Males (V501-070)

Post-Licensure Observational Study of the Safety of GARDASIL™ in Males

This is a post-licensure safety observation cohort study to describe the general safety of GARDASIL™ (a quadrivalent human papillomavirus vaccine) in males.

Inclusion criteria:

• Male vaccinated with at least one dose of GARDASIL™ after the October 2009 FDA date of first licensure of GARDASIL™ for males

Exclusion criteria all cohorts:

• Female
• Male vaccinated prior to the October 2009 FDA date of first licensure of GARDASIL™ for males
• Male who received all doses of GARDASIL™ outside of the health plan

Exclusion criteria, Regimen Completers cohort:

• Male < 9 and > 26 years of age at first dose
• Male not part of health plan at each dose
• 3-dose vaccination regimen given over a period > 12 months
• Less than 28-day interval between first and second dose
• Less than 12 weeks between the second and third dose
• Less than 24 weeks between first and third dose

Exclusion criteria, Autoimmune cohort:

- Male with less than 12 months of health plan membership prior to first dose of GARDASIL™