European study of COVID-19 vaccine effectiveness against hospitalised SARI patients laboratory-confirmed with SARS-CoV-2 (I-MOVE-COVID VE hospital study)

Study type

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

Non-interventional study

• Non-interventional study design:
  Case-control

Population studied

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

    • 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)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  1000

Study design details

• Main study objective:
  To measure product-specific COVID-19 vaccine effectiveness
• Outcomes:
  SARI laboratory confirmed as COVID-19 / SARS-CoV-2 infection, SARS-CoV-2 variant specific
• Data analysis plan:
  Test-negative design. Vaccine effectiveness: adjusted 1-OR*100 Study site as fixed effect. Time adjusted. Stratification by age group, chronic condition. Vaccine effectiveness over time.