A retrospective observational study on effectiveness of influenza vaccine Supemtek® compared to other vaccines in adults aged 18 years and above in the United Kingdom – a feasibility study

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J07BB02) influenza, inactivated, split virus or surface antigen

  influenza, inactivated, split virus or surface antigen
• Medical condition to be studied:
  Influenza

  Pneumonia influenzal

  Cardiopulmonary failure

Population studied

• Age groups:
  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:
  165331

Study design details

• Main study objective:
  The general aim of the study is to gain a better understanding of patients who received influenza vaccine and to evaluate the feasibility to run an effectiveness study of Supemtek® vaccine using UK databases.
• Outcomes:
  Type and brand of vaccine, Age at flu vaccination, Sex, Ethnicity, Index of multiple deprivation, Smoking status, Weight/BMI, Regions, Charlson Comorbidity Index score, Comorbidities recorded during baseline, Pregnancy status for women at vaccination, Primary care visits (GP) in baseline period, Influenza Vaccination status last 2 years, Pneumonia vaccination status, COVID-19 vaccination status. • Influenza hospitalisations • Pneumonia/influenza hospitalisations • Cardiorespiratory hospitalisations • Death (all cause, cause-specific)
• Data analysis plan:
  The analysis of the primary objectives will be descriptive. Distributions and descriptive statistics of central tendency (medians and arithmetic means) and dispersion (standard deviation, interquartile range) will be presented for quantitative variables wherever possible. Categorical variables will be described with frequencies and percentages. To evaluate differences between groups of patients, Chi-square test will be used for categorical variables Student’s t-tests or Wilcoxon rank sum tests (if distribution was not normal) for continuous variables. The incidence (and confidence intervals (CI)) of influenza and related hospitalization will be estimated as the number of new diagnoses during the study period dividing by the number of total person-years at risk.