DARWIN EU® - Background incidence rates of selected vaccine adverse events of special interest (AESIs) in Europe

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Additional medical condition(s):
  Vaccine adverse events of special interest

Population studied

• Short description of the study population:
  The study population will include all individuals observed in one of the participating data sources during the study period. We will require individuals to have at least 365 days of data availability before entering the cohort. The index date of cohort entry will be 1st January 2010 or the date that individual fulfil the data availability and outcome ‘clean window’ requirement.

Study design details

• Study design:
  This is a population-level retrospective, multi-database cohort study using electronic health record data from Europe. The incidence rates of AESIs will be assessed using Population Level Disease Epidemiology.
• Main study objective:
  Main objectives; 1. To estimate population level incidence rates of selected adverse events of special interest (AESIs) in the general population during 2010 and until the latest data availability, stratified by calendar year, month, sex, age groups, and data source.; 2. To estimate age and sex standardised incidence rates (to the European population) of selected adverse events of special interest (AESIs) in the general population during 2010 and until the latest data availability, stratified by calendar year.; Secondary objective; 3. To describe demographic and clinical characteristics of individuals with incident AESIs and comparing the characteristics with individuals of similar age and sex but without the AESI.