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
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

In all TND studies and the register-based study, the population under study was the general population.
TND studies: 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.
Register-based cohort: The study population consisted of all registered Finnish residents aged 6m-6y and 65-100y.

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 2018/19.

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

DRIVE_StudyReport_WP7_Season1819_v2.3_20190830_FINAL_a

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