GARDASIL(TM) Vaccine Impact in Population (VIP) Study (V501-033)

Study type

• Study topic:
  Disease /health condition

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

  Disease epidemiology

  Drug utilisation
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Cross-sectional

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)
• Medical condition to be studied:
  Genital infection female

  Genital infection viral

  Genital lesion

  Genital neoplasm malignant female

Population studied

• Short description of the study population:
  All female residents aged 18- to 45-year old in the participating Nordic countries.; Registry Data: All female residents in the participating Nordic countries who are/were alive on January 1 in the year the data will be used for analysis were included; Survey Data: All female residents alive in the participating countries on July 1, 2004 (baseline survey) and July 1, 2011 (post-vaccination survey) and subjects providing consent granting permission to use the questionnaire data and to linkage of the questionnaire data to other registry databases by using their NPIN were included.; Cervical Sample Collection:; For HPV data in general female population:; • Cervical samples from residents of the participating countries collected between 2006 and 2007, or in 2011-2012 under (including) age 45. ; For HPV data in lesional samples; • Cervical samples from women with a diagnosis of CIN or cervical cancer between 2004-2006 and 2011-2012.
• Age groups:
  • Adults (18 to < 46 years)
• Special population of interest:
  Women of childbearing potential not using contraception

  Women of childbearing potential using contraception
• Estimated number of subjects:
  470000

Study design details

• Main study objective:
  This study was conducted to assess the impact of GARDASIL(TM) human papillomavirus (HPV) vaccine on the epidemiology of HPV-related genital disease in the general female population (18- to 45-year old) by utilizing nationwide registry databases as well as primary data collection in the participating Nordic countries.
• Outcomes:
  1. To describe the incidence of select HPV-related female genital disease before and after the introduction of GARDASIL(TM)2. To describe the prevalence of HPV infection before and after the introduction of GARDASIL(TM)3. To describe congenital anomalies in babies born to women who wereinadvertently exposed to GARDASIL(TM) during their pregnancies, 1. To describe the incidence of select HPV-related female genital disease, stratified by recipient vs. non-recipient of GARDASIL(TM)2. To examine the prevalence of HPV infection in the general female population after the introduction of GARDASIL(TM)3. To characterize HPV vaccination in 18-45 year old females in the participating Nordic countries before and after introduction of GARDASIL(TM)
• Data analysis plan:
  This was a descriptive study where no formal comparisons were done between the two time points (before and after the introduction of GARDASILTM), only cross-sectional estimates of the incidence of HPV-related female genital diseases, prevalence of vaccine-type and non-vaccine type HPV infection, and pregnancy safety in women with exposure to GARDASIL(TM) during pregnancy were calculated. The study was conducted in Denmark, Norway, and Sweden. Iceland was initially included in the study but had minimal uptake of GARDASIL(TM) and was subsequently excluded from analyses of the impact of GARDASIL(TM). Iceland was included in pregnancy safety evaluation.