202055 - European Medicines Agency (EMA) post-authorisation safety study of influenza vaccine

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

  Other
• If ‘other’, further details on the scope of the study:
  Pilot study to explore the use of routinely collected data in GP practices in the UK to provide timely and relevant information on influenza vaccine safety.
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Descriptive safety surveillance study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J07BB01) influenza, inactivated, whole virus

  influenza, inactivated, whole virus

  (J07BB02) influenza, inactivated, split virus or surface antigen

  influenza, inactivated, split virus or surface antigen

  (J07BB03) influenza, live attenuated

  influenza, live attenuated
• Medical condition to be studied:
  Influenza

Population studied

• Short description of the study population:
  Individuals who receive influenza vaccination in the 9 GP practices between 1 September and 30 November 2015.
• Age groups:
  • Infants and toddlers (28 days – 23 months)
  • Children (2 to < 12 years)
  • Adolescents (12 to < 18 years)
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  11530

Study design details

• Main study objective:
  To conduct a pilot assessing adverse event of interest (AEI) frequencies among flu-vaccinated subjects using routinely collected data in nine primary care practices. Although primary surveillance is of 7-day AEI, events recorded outside this window will not be excluded but will be analysed separately. Three practices will take part in the active surveillance sub-study.
• Outcomes:
  o Weekly estimation of vaccine coverage, by age strata, and vaccine brand.o Weekly reporting of AEI rates among subjects vaccinated against seasonal influenza, by age strata, co-morbidity and vaccine brand, from nine GP practices using CMR data and from three GP practices using a card-based adverse event system. Assessment of completeness and timeliness of vaccination data in the CMR, completeness and timeliness of AEI reporting in the CMR and through ADR card reporting (within 14 days of vaccination) and assessment of incidence rates of 5 most frequently reported AEIsreported alongside those available in the literature from a similar population between 1 September 2015 and 30 November 2015.
• Data analysis plan:
  This pilot project will extract routinely collected primary care data from 9 GP practices and an active surveillance approach in 3 of the 9 GP practices to estimate proportions of Adverse events of interest (AEIs) among influenza-vaccinated individuals. Coded data will be extracted and interpreted through the creation of case-definition ontologies, that can be mapped to relevant clinical codes (Read codes). Statistical analysis will consist primarily of reporting rates and proportions. Confidence intervals will be calculated.