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

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: Human Papilloma Virus Infection

Study type: Observational

Funder types: Industry

Identifiers

NCT01567813

V501-070

EP08014.070 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 114,035 patients

Sex: Male

Ages: 9 to 26 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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™

Trial design

114,035 participants in 3 patient groups

Regimen Initiators

Description:

Any male health plan member who receives at least one dose of GARDASIL™

Regimen Completers

Description:

Regimen Initiators who complete the 3-dose vaccination regimen within 12 months

Autoimmune cohort

Description:

Regimen Initiators who were members of the health plan during the 12-month period prior to their first dose of GARDASIL™