Prospective non-interventional cohort study to assess safety and tolerability of 3Fluart 2025/2026 trivalent seasonal influenza vaccine in children, adolescents, adults and elderly subjects (3Fluart-H-36)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Evaluation of patient-reported outcomes

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name, other:
  3Fluart 2025/2026 seasonal influenza vaccine

Population studied

• Short description of the study population:
  - Children aged 3-12 years;; - Adolescents aged 13-17 years; ; - Adults aged 18-65 years; ; - Elders aged over 65 years.
• Age groups:
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)
  • Adults (18 to < 65 years)

    • Adults (18 to < 46 years)
    • Adults (46 to < 65 years)
  • Elderly (≥ 65 years)

    • Adults (65 to < 75 years)
    • Adults (75 to < 85 years)
    • Adults (85 years and over)

Study design details

• Study design:
  Prospective, non-interventional, cohort, non-randomized, open-label study.
• Main study objective:
  - To evaluate the occurrence of defined AEIs and other AEs in vaccinated subjects participating in the study; ; - To rapidly detect 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.