NCT01567813

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114,035

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2011

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 23, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 30, 2012

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

July 22, 2022

Status Verified

July 1, 2022

Enrollment Period

7.9 years

First QC Date

March 28, 2012

Last Update Submit

July 20, 2022

Conditions

Human Papilloma Virus Infection

Keywords

WartsPapillomavirus infectionsDNA virus infectionsVirus diseasesSkin diseases, viralTumor virus infectionsSkin diseases, infectiousSkin diseases

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Study Arms (3)

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 Criteria

Age9 Years - 26 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Male vaccinated with at least one dose of GARDASIL™ after the October 2009 FDA date of first licensure of GARDASIL™ for males

You may not qualify if:

  • 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
  • Male \< 9 and \> 26 years of age at first dose
  • Male not part of health plan at each dose
  • 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
  • \- Male with less than 12 months of health plan membership prior to first dose of GARDASIL™

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Amend KL, Turnbull B, Zhou L, Marks MA, Velicer C, Saddier P, Seeger JD. Safety of 4-valent human papillomavirus vaccine in males: a large observational post-marketing study. Hum Vaccin Immunother. 2022 Nov 30;18(5):2073750. doi: 10.1080/21645515.2022.2073750. Epub 2022 Jun 17.

    PMID: 35714277RESULT

  • Seeger JD, Amend KL, Turnbull BR, Zhou L, Marks MA, Velicer C, Saddier P. Incident autoimmune conditions among males receiving quadrivalent human papillomavirus vaccine in the United States. Vaccine. 2023 Mar 10;41(11):1826-1833. doi: 10.1016/j.vaccine.2022.10.050. Epub 2022 Nov 21.

    PMID: 36424257DERIVED

MeSH Terms

Conditions

Papillomavirus InfectionsWartsDNA Virus InfectionsVirus DiseasesSkin Diseases, ViralTumor Virus InfectionsSkin Diseases, InfectiousSkin Diseases

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2012

First Posted

March 30, 2012

Study Start

June 23, 2011

Primary Completion

June 1, 2019

Study Completion

June 1, 2019

Last Updated

July 22, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will share

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

More information