DRIVE - Brand-specific influenza vaccine effectiveness in Europe, season 2021/22 (DRIVE 2021/22)

Study type

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

Non-interventional study

• Non-interventional study design:
  Case-control

  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J07BB) Influenza vaccines

  Influenza vaccines
• Medical condition to be studied:
  Influenza

Population studied

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

    • Adolescents (12 to < 18 years)
    • Children (2 to < 12 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:
  200000

Study design details

• Main study objective:
  To estimate brand-specific seasonal influenza vaccine effectiveness in Europe by health care setting and age group, influenza season 2021/22.
• Outcomes:
  laboratory confirmed influenza, by type and subtype/lineage
• Data analysis plan:
  Site-specific confounder-adjusted influenza vaccine effectiveness estimates will be obtained using logistic or Poisson regression, depending on the study design. The site-specific estimates will be pooled using random effects meta-analysis.