Human Papilloma Virus Infection
Conditions
Keywords
Warts, Papillomavirus infections, DNA virus infections, Virus diseases, Skin diseases, viral, Tumor virus infections, Skin diseases, infectious, Skin diseases
Brief summary
This is a post-licensure safety observation cohort study to describe the general safety of GARDASIL™ (a quadrivalent human papillomavirus vaccine) in males.
Interventions
None listed
Sponsors
Merck Sharp & Dohme LLC
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
9 Years to 26 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Outcome results
None listed