Post-Marketing surveillance for the safety of GARDASIL® and GARDASIL®9 in a cohort of Chinese women

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 data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Safety surveillance of G4 or G9 vaccination

Study drug and medical condition

• Name of medicine:
  Gardasil 9

Population studied

• Short description of the study population:
  Women between ages of 16 and 45 years old during the study period (i.e., age-eligible for vaccination with G4 and/or G9) who are residents of Ningbo, whose medical care information is available in the NRHIP, and who received at least one dose of G4 or G9 as part of routine health care. Ningbo has a population of approximately 2.8 million local female residents between the ages of 16-45 years old. Women selfpay for the 3-dose regimen of G4 or G9. For the pregnancy surveillance, the study population includes women who had pregnancy exposure to G4 or G9, and their infants.
• Age groups:
  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  50000

Study design details

• Main study objective:
  To monitor within the NRHIP the diagnosis of 7 pre-specified new-onset autoimmune disorders diagnosed within up to 6 months after each dose of GARDASIL® or GARDASIL®9 in Chinese women, and the occurrence of stillbirth and major congenital anomaly in infants of Chinese women who were inadvertently vaccinated with GARDASIL® or GARDASIL®9 up to 30 days prior to conception or anytime during pregnancy.
• Outcomes:
  Graves’ disease, Hashimoto’s disease, type 1 diabetes, systemic lupus erythematosus, multiple sclerosis, optic neuritis, uveitis, stillbirth and congenital anomalies.
• Data analysis plan:
  A summary of the number of vaccinated women who received GARDASIL® and GARDASIL®9 will be provided, and this information will also be stratified by age, calendar year of vaccination, number of doses, timing between doses, and similar factors. Descriptive analysis of outcomes of interest will be reported. Counts of women with new onset autoimmune disease within 6 months after vaccination will be provided for the 7 pre-specified conditions. Counts of stillbirths and congenital anomalies occurring in infants of women who received at least one dose of GARDASIL® and GARDASIL®9 up to 30 days priorto conception or anytime during pregnancy will also be included in the data summary. A summary of the case validation methods and results will also be provided.

Documents

Study results

V503-055 G4 G9 combined_final redaction_0

V503-055-CSR-HPV PMC G9 Safety Study Report_final redaction