Overview

This trial is active, not recruiting.

Condition human papilloma virus infection
Phase phase 4
Sponsor Merck Sharp & Dohme Corp.
Start date June 2011
End date June 2018
Trial size 44000 participants
Trial identifier NCT01567813, EP08014.070, V501-070

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
Any male health plan member who receives at least one dose of GARDASIL™
Regimen Initiators who complete the 3-dose vaccination regimen within 12 months
Regimen Initiators who were members of the health plan during the 12-month period prior to their first dose of GARDASIL™

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

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™

Additional Information

Official title Post-Licensure Observational Study of the Safety of GARDASIL™ in Males
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Merck Sharp & Dohme Corp..