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Post-Licensure Study of the Safety of GARDASIL™ in Males (V501-070 AM1)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01567813
First received: March 28, 2012
Last updated: April 17, 2012
Last verified: April 2012
History of Changes
  Purpose

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


Condition
Human Papilloma Virus Infection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Post-Licensure Observational Study of the Safety of GARDASIL™ in Males

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 44000
Study Start Date: June 2011
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Regimen Initiators
Any male health plan member who receives at least one dose of GARDASIL™
Regimen Completers
Regimen Initiators who complete the 3-dose vaccination regimen within 12 months
Autoimmune cohort
Regimen Initiators who were members of the health plan during the 12-month period prior to their first dose of GARDASIL™

  Eligibility

Ages Eligible for Study:   9 Years to 26 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Males who are members of a large geographically diverse US health plan.

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™

  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01567813     History of Changes
Other Study ID Numbers: V501-070
Study First Received: March 28, 2012
Last Updated: April 17, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck:
Warts
Papillomavirus infections
DNA virus infections
Virus diseases
 Skin diseases, viral
Tumor virus infections
Skin diseases, infectious
Skin diseases

Additional relevant MeSH terms:
Papilloma
Virus Diseases
Warts
Papillomavirus Infections
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
DNA Virus Infections
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on June 13, 2013