Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Effectiveness study (incl. comparative)

Data collection methods

Combined primary data collection and secondary use of data
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

Short description of the study population

In all TND studies and the register-based study, the population under study is the general population. In the 2020/21 season, the NIID hospital is dedicated to the treatment of COVID-19, hence, for NIID the study population is the general population with a hospitalized COVID-19 infection.

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)

Special population of interest

Other

Special population of interest, other

Influenza patients

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 2020/21.

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
English (2.7 MB - PDF)View document