COVID-19 vaccine effectiveness at primary care level in Europe: generic protocol (I-MOVE-COVID primary care VE)

Study type

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

Non-interventional study

• Non-interventional study design:
  Case-control

  Other
• Non-interventional study design, other:
  Sentinel sites

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)
• Estimated number of subjects:
  1000

Study design details

• Main study objective:
  To measure COVID vaccine effectiveness against acute respiratory infection laboratory confirmed as SARS-CoV-2
• Outcomes:
  ARI laboratory confirmed as SARS-CoV-2, Variant specific
• Data analysis plan:
  Vaccine effectiveness = 1-adjusted OR*100 Log reg adjusted OR comparing ARI cases testing positive for SARS-CoV-2 to ARI patients testing negative. Study site as fixed effect. Time adjusted OR stratified by age group, chronic condition, period of time. Brand specific.