Study type

Study type

Non-interventional study

Scope of the study

Effectiveness study (incl. comparative)
Non-interventional study

Non-interventional study design

Cohort
Other

Non-interventional study design, other

Population-based study
Study drug and medical condition

Medical condition to be studied

Papilloma viral infection
Population studied

Age groups

  • Paediatric Population (< 18 years)
    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)

Estimated number of subjects

3300000
Study design details

Main study objective

To estimate the effectiveness of the HPV vaccines to prevent genital warts in women aged from 14 to 23+ years old (depending on the date of data extraction).

Outcomes

Incident cases of Genital Warts in primary care and outpatient clinics. Precancerous lesions

Data analysis plan

Crude and adjusted VE overall and in IC population for bivalent and quadrivalent vaccines and the risk of GW in IC subjects respect to IC-free will be estimated by statistical models considering time-dependent variables. Variables that are relevant to the disease or can impact on the incidence of genital warts will be considered.