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

Human Papilloma Virus Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01567813
• Other study ID #: V501-070
• Secondary ID: EP08014.070
• Status: Completed
• Start date: June 23, 2011
• Est. completion date: June 1, 2019

Study information

• Verified date: July 2022
• Source: Merck Sharp & Dohme LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114035
• Est. completion date: June 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 9 Years to 26 Years

Eligibility

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™

Related Conditions & MeSH terms

• Human Papilloma Virus Infection
• Infections
• Papilloma
• Papillomavirus Infections
• Virus Diseases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC

References & Publications (1)

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 Jun 17:2073750. doi: 10.1080/21645515.2022.2073750. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)
Secondary	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

External Links

•   EU PAS Registry Results