Observational influenza vaccine active surveillance study: A Phase IV Prospective Multi-Centre Cohort Study to Evaluate the Reactogenicity of bioCSL’s influenza virus vaccine (2015/2016 formulation) (CSLCT-SAF-15-07)

Study type

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

  Safety study (incl. comparative)
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  TRIVALENT INFLUENZA VACCINE

Population studied

• Short description of the study population:
  This observational post-marketing study is designed to capture the population receiving bioCSL’s influenza virus vaccine regardless of age or health status in order to provide a picture of the safety profile in routine practice. Pregnant and immune-compromised participants, and children aged less than 5 are not excluded from this study if they have been administered bioCSL’s influenza virus vaccine as part of routine care, or inadvertently prior to enrolment in the study. The source of the population will be people who present to general practice or pharmacies for influenza vaccination, either through mass vaccination clinics or opportunistic vaccination during routine consultations or pharmacy visit for the influenza vaccination season, and have received bioCSL’s influenza virus vaccine. Inclusion criteria:Receipt of at least one vaccination of bioCSL’s influenza virus vaccine after 1 July 2015
• Age groups:
  • Paediatric Population (< 18 years)

    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Special population of interest:
  Immunocompromised

  Pregnant women
• Estimated number of subjects:
  400

Study design details

• Main study objective:
  To characterise the reactogenicity (local, systemic and allergic reactions) within seven days after each influenza vaccination with bioCSL’s influenza virus vaccine in participants routinely indicated for influenza vaccination in specified age groups.
• Outcomes:
  The reactogenicity of bioCSL’s influenza vaccine will be assessed by summarising reports of solicited adverse events occurring within seven days after each vaccination. Solicited events include injection site, systemic and allergic reactions. Participants will also be asked to indicate if they did not experience any adverse events to distinguish between no reported AE and missing data. Information on Medically attended Adverse Events (MAEs) will be recorded for medical attendances that relate to events occurring within seven days after each influenza vaccination.
• Data analysis plan:
  Summary descriptive statistics of continuous data will be presented as number of observations, mean, standard deviation (SD), median, minimum and maximum. For categorical variables, statistical summaries will include counts and percentages relative to the appropriate population. Two sided 95% confidence intervals will be provided for descriptive statistics, as warranted.