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

July 20, 2022 updated by: Merck Sharp & Dohme LLC

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

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

114035

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 26 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

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

Description

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™

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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™

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: Within 60 days after each dose
Within 60 days after each dose

Secondary Outcome Measures

Outcome 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
Time Frame: Within 60 days after the first dose
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)
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
Within 6 months after each dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2011

Primary Completion (Actual)

June 1, 2019

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

March 28, 2012

First Submitted That Met QC Criteria

March 29, 2012

First Posted (Estimate)

March 30, 2012

Study Record Updates

Last Update Posted (Actual)

July 22, 2022

Last Update Submitted That Met QC Criteria

July 20, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V501-070
  • EP08014.070 (Other Identifier: Merck)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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