Post-Licensure Study of the Safety of GARDASIL™ in Males (V501-070)
This trial is active, not recruiting.
|Condition||human papilloma virus infection|
|Sponsor||Merck Sharp & Dohme Corp.|
|Start date||June 2011|
|End date||June 2018|
|Trial size||44000 participants|
|Trial identifier||NCT01567813, EP08014.070, V501-070|
This is a post-licensure safety observation cohort study to describe the general safety of GARDASIL™ (a quadrivalent human papillomavirus vaccine) in males.
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
time frame: Within 60 days after each dose
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
time frame: Within 60 days after the first dose
Incidence of syncope, convulsive syncope, epilepsy, convulsions, head trauma, and allergic reactions on the day of vaccination
time frame: 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
time frame: Within 6 months after each dose
Male participants from 9 years up to 26 years old.
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™
|Official title||Post-Licensure Observational Study of the Safety of GARDASIL™ in Males|
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