Study of Vaccine Efficacy in Health Care Workers (PSVEHCW)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  SARS-CoV-2 test positive

  COVID-19 immunisation

Population studied

• Age groups:
  • 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:
  Renal impaired

  Hepatic impaired

  Immunocompromised

  Pregnant women
• Estimated number of subjects:
  300000

Study design details

• Main study objective:
  1. To determine the real-world efficacy of COVID-19 vaccination in HCWs. 2. To determine the effect of vaccinating HCWs on the risk of COVID-19 in individuals with whom they share a household as such an effect would be consistent with an effect of vaccination on transmission
• Outcomes:
  Any case of COVID-19 defined as the first positive test for SARS-CoV-2. Hospitalisation with COVID-19 Severe COVID-19, ie COVID-19 resulting in ICU admission or death
• Data analysis plan:
  Extended cox-models to estimate the hazard ratio for vaccination, treating vaccination as a time-varying covariate.