Passive Enhanced Safety Surveillance (ESS) of Quadrivalent Live Attenuated Influenza Vaccine (QLAIV) Fluenz Tetra in Children and Adolescents during the early 2015/2016 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:
  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 and adolescents aged 2–17 years administered with QLAIV (exposure) at participating vaccination sites. Vaccinees with co-morbidities, who take medication, or who received additional vaccines on the same day or within 1 month of receiving QLAIV were included
• Age groups:
  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)
• Estimated number of subjects:
  10000

Study design details

• Main study objective:
  Development of early influenza season passive Enhanced Safety Surveillance (ESS) for Fluenz Tetra, in children and adolescents in England, with pilot implementation in the 2015 ‘flu season.
• 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.

Documents

Study publications

McNaughton R, Lynn E, Osborne V, Coughtrie A, Layton D, Shakir S. Safety of int…