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


N/A
9 Years
26 Years
Open (Enrolling)
Male
Human Papilloma Virus Infection

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Trial Information

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

Inclusion 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™

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Retrospective

Outcome 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

Outcome Time Frame:

Within 60 days after each dose

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

V501-070

NCT ID:

NCT01567813

Start Date:

June 2011

Completion Date:

June 2017

Related Keywords:

  • Human Papilloma Virus Infection
  • Warts
  • Papillomavirus infections
  • DNA virus infections
  • Virus diseases
  • Skin diseases, viral
  • Tumor virus infections
  • Skin diseases, infectious
  • Skin diseases
  • Papilloma
  • Virus Diseases
  • Warts
  • Papillomavirus Infections

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