Clinical trial · Observational
Post-Licensure Study of the Safety of GARDASIL™ in Males (V501-070)
Post-Licensure Observational Study of the Safety of GARDASIL™ in Males
NCT01567813CI-TRIAL-00059809completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a post-licensure safety observation cohort study to describe the general safety of GARDASIL™ (a quadrivalent human papillomavirus vaccine) in males.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Human Papilloma Virus Infection | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- Regimen Initiators
- description
- Any male health plan member who receives at least one dose of GARDASIL™
- label
- Regimen Completers
- description
- Regimen Initiators who complete the 3-dose vaccination regimen within 12 months
- label
- Autoimmune cohort
- description
- Regimen Initiators who were members of the health plan during the 12-month period prior to their first dose of GARDASIL™
Primary outcomes (1)
- 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 (3)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 9 Years
- Maximum age
- 26 Years
Show eligibility criteria text
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™
References
Publications (2)
- RESULTAmend 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 35714277
- DERIVEDSeeger 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 36424257