Prospective non-interventional cohort study to assess safety and tolerability of 3Fluart 2017/2018 trivalent seasonal influenza vaccine in children, adolescents, adults and elderly subjects (3Fluart-H-20)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Intensive monitoring schemes

Study drug and medical condition

• Name of medicine, other:
  3Fluart suspension for injection (influenza vaccine, whole virion, inactivated, adjuvanted)

Population studied

• Short description of the study population:
  All subjects vaccinated with a single dose of 3Fluart vaccine containing influenza virus strains recommended for the 2017/2018 seasonal epidemics in accordance with the SmPC will be involved into the study.
• 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)
• Estimated number of subjects:
  600

Study design details

• Main study objective:
  To detect a potential increase in reactogenicity and allergic events that is instrinsic to the product in near real-time as part of the active surveillance of subjects vaccinated with 3Fluart vaccine containing influenza virus strains recommended for the 2017/2018 seasonal epidemics in accordance with the Summary of Product Characteristics.
• Data analysis plan:
  The assessment of safety and tolerability will be primarily based on the occurrence rates of adverse reactions. The occurrence rates of adverse reactions will be summarized by SOC (System Organ Class) and PT (Preferred Term) and compared to what was already known or expected with 3Fluart vaccine as follows: Evaluation of the occurrence of AEIs and other AEs in vaccinated subjects participating in the study. Occurrence rate of each AE will be presented by age group and severity. Rapid detection of any clinically significant change compared to what was known or expected with the previous vaccine compositions in the frequency and severity of ARs in vaccinated subjects participating in the study. Comparison will be performed between ARs of the study and ARs observed in the last post-authorization safety study performed with 3Fluart influenza vaccine, further, between ARs of the study and with those defined in the SmPC of 3Fluart influenza vaccine.

Documents

Study, other information

3Fluart-H-20 Vizsgálati helyszínek, vizsgálatvezetők felsorolása_v01_20170602