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NCT Number: NCT01567813

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

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

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Key information

Conditions

Human Papilloma Virus Infection Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Skin Diseases Skin Diseases, Infectious Skin Diseases, Viral Skin and Connective Tissue Diseases Tumor Virus Infections Urogenital Diseases Virus Diseases Warts

Age range

9 year–26 year

Sex eligibility

Male

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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™

Treatment and study plan

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

    Time frame: Within 60 days after each dose

Secondary outcomes

  1. 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

    Time frame: Within 60 days after the first dose

  2. Incidence of syncope, convulsive syncope, epilepsy, convulsions, head trauma, and allergic reactions on the day of vaccination

    Time frame: Day of vaccination for each dose received (1 day for each dose, up to 3 total days)

  3. 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

    Time frame: Within 6 months after each dose

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2019
Study completion
2019
First posted
Mar 30, 2012
Registry last updated
Jul 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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