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

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

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

Conditions
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Human Papilloma Virus Infection

Participation Criteria
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Eligibility Criteria
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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™

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 26 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Regimen Initiators<br>Any male health plan member who receives at least one dose of GARDASIL™ | |
| Regimen Completers<br>Regimen Initiators who complete the 3-dose vaccination regimen within 12 months | |
| Autoimmune cohort<br>Regimen Initiators who were members of the health plan during the 12-month period prior to their first dose of GARDASIL™ | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of health outcomes resulting in emergency room visits or hospitalizations in 60-day risk periods after each dose of GARDASIL™ compared to post-vaccination self-comparison periods |  | Within 60 days after each dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of health outcomes resulting in emergency room visits or hospitalizations in the 60-day risk period following the first dose of GARDASIL™ compared to post-vaccination self-comparison periods |  | Within 60 days after the first dose | 
| Incidence of syncope, convulsive syncope, epilepsy, convulsions, head trauma, and allergic reactions on the day of vaccination |  | Day of vaccination for each dose received (1 day for each dose, up to 3 total days) | 
| Incidence of pre-specified new-onset conditions identified from the hospital, outpatient, and emergency room setting for 6 months after each dose of GARDASIL™ compared to the incidence of these conditions in an un-vaccinated population of males |  | Within 6 months after each dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Warts, Papillomavirus infections, DNA virus infections, Virus diseases, Skin diseases, viral, Tumor virus infections, Skin diseases, infectious, Skin diseases