217743 - An observational, retrospective database post-authorisation safety study (PASS) to assess trends and changes over time in incidence of anal cancer and feasibility for a case-control study in European countries that introduced Cervarix in their National Immunisation Programmes (NIP) (EPI-HPV-099 VS EUR DB)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Observational, retrospective database study

Study drug and medical condition

• Name of medicine:
  CERVARIX
• Medical condition to be studied:
  Anal cancer

Population studied

• Short description of the study population:
  The study population included males and females of all age groups identified from the national cancer registries in Finland, the Netherlands, England, Denmark, and Norway to understand the incidence of anal cancer.
• Age groups:
  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with anal cancer
• Estimated number of subjects:
  0

Study design details

• Main study objective:
  To assess trends and changes over time in the age-standardised incidence and in the crude incidence of anal cancer by age category (in the case of crude incidence), by sex, HPV-type and histological classification for each country* separately. *Five European countries are considered for this study and each country will be selected based on a set of criteria.
• Outcomes:
  Age-standardised and crude incidence of anal cancer by age category (in the case of crude incidence), by sex, HPV-type and histological classification for each country separately, incidence of small intestine cancer by age category and sex for each country separately. Number of anal cancer cases expected to demonstrate vaccine effectiveness for each country separately.
• Data analysis plan:
  Analysis will be performed using the country-specific data extracted from the national cancer registries as per defined population and timeframe.

Documents

Study results

Study_Report_Interim_Anonymized