A non-interventional study of LAIV utilization to identify and characterize medication errors due to expired vaccine use in individuals 2-17 years of age in the CPRD

Study type

• Study topic:
  Other
• Study topic, other:
  Medication errors, Disease/Epidemiology study
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective Database

Population studied

• Short description of the study population:
  Children and adolescents who were administered LAIV from September 1 2013 to March 31 2014 and from September 1 2014 to March 31 2015, aged 2 through 17 years at the time of LAIV administration. All patients with LAIV administration during the influenza season with valid LAIV lot identifiers were included.
• Age groups:
  • Paediatric Population (< 18 years)

    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
• Estimated number of subjects:
  134000

Study design details

• Main study objective:
  The overall aim for this study is to identify and characterize the proportion of LAIV administrations that used expired product during the two most recent influenza seasons and to identify risk factors that may be associated with administration of an expired dose of LAIV. In addition, there is interest in quantifying the frequency distribution of days between expiration and vaccination da
• Outcomes:
  To measure administrations of LAIV beyond the expiry date in individuals aged 2 through 17 years during the past two influenza seasons (September 2013 – March 2014 and September 2014 – March 2015) in the UK through use of the CPRD. To investigate risk factors that may be associated with administration of an expired dose of LAIV:• Time of administration: season and timing during the season• Population characteristics: age, gender, comorbidities, and region• Characteristics of physician practices in terms of size and geographic region To quantify the frequency distribution of days between dose expiration dates a
• Data analysis plan:
  The proportion of individuals receiving expired LAIV vaccine during each influenza season (September 2013 – March 2014 and September 2014 – March 2015) is defined as the number of children and adolescents receiving expired vaccine during each season divided by the total number of children and adolescents with valid lot LAIV administrations during each influenza season. The proportion of individuals receiving expired vaccine and 95% CIs will be reported. Median intervals and measures of dispersion in days between vaccinations and vaccine expiration dates will also be described. With due attention to the seasonal time period of receiving an expired LAIV, the proportion of patients receiving expired LAIV as medication errors will be calculated by age group and by gender