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

  • 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 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.