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

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Descriptive observational study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J07BM01) papillomavirus (human types 6, 11, 16, 18)

  papillomavirus (human types 6, 11, 16, 18)

Population studied

• Short description of the study population:
  Male patients who received at least one dose of GARDASIL® identified from the Optum research database in the US from 16 October 2009 to 31 December 2016 with follow up through 31 May 2017.
• Age groups:
  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)
• Estimated number of subjects:
  44000

Study design details

• Main study objective:
  This is a post-licensure observational cohort study to describe the general safety of GARDASIL(TM) in males.
• Outcomes:
  The primary outcome is the incidence of health outcomes resulting in an emergency room visit or hospitalization after receipt of GARDASIL(TM)compared to post-vaccination self-comparison periods. The secondary outcomes are (1) Incidence of health outcomes resulting in an emergency room visit or hospitalization following the first dose of GARDASIL(TM), (2) incidence of syncope, convulsive syncope, epilepsy, convulsions, head trauma, and allergic reactions on the day of vaccination, and (3) incidence of new-onset autoimmune conditions.
• Data analysis plan:
  Incidence and relative risks will be calculated for primary and secondary outcomes. Relative risks will be calculated as the ratio of the incidence of the health outcome in the risk and comparison periods. Confidence intervals (CIs) will be calculated using the mid-probability exact method.

Documents

Study results

p070v501_final-redaction

Study report

V501-070-01 Study Results-Interim Report

V501-070-supplemental-report-aug-2020_Final Redaction Pages 1-73

Study, other information

V501-070-supplemental-report-aug-2020_Final Redaction Pages 1-73.pdf

Study publications

Amend KL, Turnbull B, Zhou L, Marks MA, Velicer C, Saddier P, Seeger JD. Vaccin…

Seeger JD, Amend KL, Turnbull BR, Zhou L, Marks MA, Velicer C, Saddier P. Incid…

Amend KL, Turnbull B, Zhou L, Marks MA, Velicer C, Saddier P, Seeger JD. Safety…