Prospective non-interventional cohort study to assess safety and tolerability of Fluval AB 2014/2015 trivalent seasonal influenza vaccine in children, adolescents, adults and elderly subjects (FluvalAB-H-17)

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, Active surveillance

Study drug and medical condition

• Name of medicine, other:
  Fluval AB suspension for injection

Population studied

• Short description of the study population:
  Children and adults previously vaccinated with a single dose of Fluval AB suspension for injection (influenza vaccine, whole virion, inactivated, adjuvanted).
• 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 estimate the occurrence of adverse events in vaccinated subjects participating in the study and to rapidly detect a clinically significant change (compared to what was known or expected with the previous vaccine composition) in the frequency and severity of AEIs in vaccinated subjects participating in the study that may indicate a potential for more serious risks as exposure.
• Data analysis plan:
  All AEs will be coded using the latest approved version of MedDRA. The occurrence rates of AEs will be stratified per age groups and gender, summarized by System Organ Class (SOC), High Level Term (HLT) and Preferred Term (PT), and compared to that expected for Fluval AB vaccine (according to the SmPC), in order to evaluate the potential for an increased risk related to vaccination therewith, than already known.