Clinical trial NCT01567813: Post-Licensure Study of the Safety of GARDASIL™ in Males (V501-070)
Official title: Post-Licensure Observational Study of the Safety of GARDASIL™ in Males
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Papilloma Virus Infection
Keywords: Warts
Papillomavirus infections
DNA virus infections
Virus diseases
Skin diseases, viral
Tumor virus infections
Skin diseases, infectious
Skin diseases
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2012-03-30
Enrollment: 114035
Sex: MALE
Minimum age (years): 9
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Males who are members of a large geographically diverse US health plan.

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.


Eligibility 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™

Primary outcomes:
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
timeFrame: Within 60 days after each dose
Secondary outcomes:
measure: 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
timeFrame: Within 60 days after the first dose
measure: Incidence of syncope, convulsive syncope, epilepsy, convulsions, head trauma, and allergic reactions on the day of vaccination
timeFrame: Day of vaccination for each dose received (1 day for each dose, up to 3 total days)
measure: 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
timeFrame: Within 6 months after each dose
Other outcomes:
Locations:
Study officials:
References:
citation: 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.