Retrospective cohort study evaluating effectiveness of GARDASIL™ against adult-onset recurrent respiratory papillomatosis in Norway

Study type

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

  Disease epidemiology

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  GARDASIL

  GARDASIL 9
• Name of medicine, other:
  - human papillomavirus vaccine [types 6, 11, 16, 18] (recombinant, adsorbed); - human papillomavirus 9-valent vaccine (recombinant, adsorbed);
• Anatomical Therapeutic Chemical (ATC) code:
  (J07BM01) papillomavirus (human types 6, 11, 16, 18)

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

  (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)
• Medical condition to be studied:
  Respiratory papilloma
• Additional medical condition(s):
  Adult-onset recurrent respiratory papillomatosis, Juvenile-onset Recurrent respiratory papillomatosis

Population studied

• Age groups:
  • Paediatric Population (< 18 years)

    • Neonate

      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
• Estimated number of subjects:
  3000000

Study design details

• Main study objective:
  The primary objective is to assess whether vaccination with GARDASIL/GARDASIL 9 before 17 years of age reduces the risk of adult-onset RRP.
• Outcomes:
  Incidence of adult-onset RRP among females measured using ICD-10 code D14.1, 1) Incidence of adult-onset RRP among males and females measured using ICD-10 code D14.1 2) Incidence of juvenile-onset RRP among males and females measured using ICD-10 code D14.1.
• Data analysis plan:
  The data will be analyzed for the primary objective using a Cox Proportional Hazards Model for the risk of first adult-onset RRP incidence, using age as running time. For the secondary objectives, age-standardized incidence rates of juvenile-onset RRP and adult-onset RRP will be calculated stratified by age group and calendar period.