Passive Enhanced Safety Surveillance (ESS) of Quadrivalent Live Attenuated Influenza Vaccine (QLAIV) Fluenz Tetra in Children and Adolescents during the early 2016/2017 Influenza Season in England

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:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  FLUENZ

Population studied

• Short description of the study population:
  Children and adolescents during the 2016/2017 influenza season who had received Quadrivalent Live Attenuated Influenza Vaccine (QLAIV) Fluenz Tetra in England.
• Age groups:
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)
• Estimated number of subjects:
  10000

Study design details

• Main study objective:
  To conduct early influenza season passive Enhanced Safety Surveillance (ESS) for Fluenz Tetra, in children and adolescents in England, to facilitate the rapid collection and analysis of data on suspected adverse drug reactions (sADRs) experienced by vaccines.
• 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 study report.