Pilot study: reactogenicity surveillance in Belgium following immunization with seasonal influenza vaccines

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Feasibility analysis
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine, other:
  Alpharix Tetra
• Medical condition to be studied:
  Immunisation reaction

  Allergy to vaccine

Population studied

• Short description of the study population:
  Subjects aged 18 to 65 years who had received inactivated seasonal influenza vaccine in occupational setting.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
• Estimated number of subjects:
  100

Study design details

• Main study objective:
  To assess whether reactogenicity data can be collected in a timely manner in Belgium, i.e. complete enrolment within one month after the start of vaccination in Belgium.
• Outcomes:
  The number of days between start of vaccination campaign in Belgium and recruitment of 100 subjects. Enrolment rate (how man vaccinees have to be approached to reach 100 succesful enrolments), completion of follow-up.
• Data analysis plan:
  Number of days between start of vaccination campaign in Belgium and complete enrolment.Enrolment rate.Rate of completion of follow-up.Rates of reactenogicity/ allergic events.