DRIVE - Brand-specific influenza vaccine effectiveness in Europe, season 2019/20 (DRIVE 2019/20)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Combined primary and secondary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Case-control

  Systematic review and meta-analysis

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J07BB) Influenza vaccines
• Medical condition to be studied:
  Influenza

Population studied

• Short description of the study population:
  The study population consisted of non-institutionalized subjects ≥6 months of age, with no contraindication for influenza vaccination, no prior positive influenza test in the same season, and with a swab taken < 8 days after ILI/SARI onset. In hospital settings, subjects hospitalized <48h prior to symptom onset or with symptom onset ≥48h after hospital admission were excluded (to exclude nosocomial infection).
• Age groups:
  Infants and toddlers (28 days – 23 months)

  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:
  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 2019/20.
• 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.

Documents

Study results

D7.7.DRIVE_IVE_Study_Report_1920_Final