A Postmarketing Noninterventional Cohort Study of the Safety of Live Attenuated Influenza Vaccine (LAIV) in Subjects 2 Through 17 Years of Age (Flu vaccine feedback study)

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  FLUENZ

Population studied

• Short description of the study population:
  Children 2 to 17 years of age who had received nasal LAIV, Fluenz Tetra® vaccine during the 2014/2015 influenza season.
• Age groups:
  • Paediatric Population (< 18 years)

    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
• Estimated number of subjects:
  600

Study design details

• Main study objective:
  To rapidly detect a clinically significant change (compared to what was known or expected of the previous year’s influenza vaccine) in the frequency and/or severity of expected reactogenicity after administration of Fluenz Tetra® in children 2 to 17 years of age that may indicate a potential for more serious risks as the frequency of exposure to the vaccine increases.
• Data analysis plan:
  Summary descriptive statistics of basic demographic information, patient characteristics, co-morbidities, concomitant medications and AEIs will be presented. Numbers of cases (frequencies) and incidence rates overall, by age group and by batch for each endpoint/recorded adverse event of interest will be included in the expedited summary report.