Post-licensure Observational Safety Study of Gardasil 9 (V503-028)

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:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Retrospective, observational self-controlled risk interval (SCRI) study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J07BM03) papillomavirus (human types 6, 11, 16, 18, 31, 33, 45, 52, 58)

  papillomavirus (human types 6, 11, 16, 18, 31, 33, 45, 52, 58)

Population studied

• Short description of the study population:
  The study focused subjects aged 9 years or older who received at least one dose of the 9vHPV vaccine and were members of the health plan at the time of the dose. Exclusions include those who received any doses outside the health plan. ; The study cohorts are divided into the 9vHPV-Only Cohort, those who initiated the vaccination and received at least one dose of the vaccine, and the Any 9vHPV Cohort, those who received at least one dose of the vaccine regardless of exposure to the 4vHPV vaccine before and had no exposure to any other HPV vaccines.
• Age groups:
  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)
• Estimated number of subjects:
  10000

Study design details

• Main study objective:
  The objective of this study is to describe the general safety of the 9vHPV vaccine in a population of 10,000 males and females who have received at least one dose of the 9vHPV.
• Outcomes:
  Estimating the risk of health outcomes resulting in emergency room visits or hospitalizations occurring within a pre-specified risk period after a dose of the 9vHPV vaccine, and comparing to the risk of such health outcomes in a post-vaccination self-comparison reference period.
• Data analysis plan:
  For each health outcome that results in a hospitalization or emergency room visit during the risk and/or self-comparison periods, the risk (i.e. incidence rate) will be calculated and presented for emergency room visits and hospitalizations combined. Relative risk of health outcomes as estimated by the odds ratios and 95% confidence intervals (CI’s) will be estimated with conditional logistic regression.

Documents

Study results

V503-028-final-report_Final Redaction

Study publications

Hansen J, Yee A, Lewis N, Li S, Velicer C, Saddier P, Klein NP. Safety of 9-val…