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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

114035 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-23

Study Completion Date

2019-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

An Investigational Study of Gardasil™ (qHPV Vaccine) in Reducing the Incidence of Anogenital Warts in Young Men (V501-020)

NCT00090285

Condylomata Acuminata

COMPLETED PHASE3

Human Papilloma Virus Genotypes and Treatment Outcomes of Intralesional Immunotherapy of Anogenital Warts

NCT05761002

Human Papilloma Virus Anogenital Wart

UNKNOWN NA

Broad Spectrum HPV Vaccine Dose Escalation Study (V502-002)

NCT00851643

Human Papilloma Virus Cervical Cancer Vulvar Cancer +2 more

COMPLETED PHASE1

Efficacy of Quadrivalent HPV Vaccine to Prevent Relapses of Genital Warts After Initial Therapeutic Response

NCT03296397

Genital Warts

UNKNOWN PHASE3

Efficacy of Booster Injection With Gardasil-9 Vaccine on Intersurgical Interval* for Adults With Recurrent Respiratory Papillomatosis*

NCT07339163

Recurrent Respiratory Papillomatosis (RRP)

NOT_YET_RECRUITING PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Human Papilloma Virus Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Regimen Initiators

Any male health plan member who receives at least one dose of GARDASIL™

No interventions assigned to this group

Regimen Completers

Regimen Initiators who complete the 3-dose vaccination regimen within 12 months

No interventions assigned to this group

Autoimmune cohort

Regimen Initiators who were members of the health plan during the 12-month period prior to their first dose of GARDASIL™

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

* 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
* 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

\- Male with less than 12 months of health plan membership prior to first dose of GARDASIL™

Minimum Eligible Age

9 Years

Maximum Eligible Age

26 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes