Observational influenza vaccine active surveillance study: A Phase IV Prospective Multi-Centre Cohort Study to Evaluate the Reactogenicity of bioCSL’s influenza virus vaccine (CSLCT-SAF-14-05)

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:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine, other:
  Enzira® (2014/15) Influenza vaccine (2014/15)

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 for influenza vaccination, either through mass vaccination clinics or opportunistic vaccination during routine consultations for the influenza vaccination season, and have received bioCSL’s influenza virus vaccine. Inclusion criteria: Population who received at least one vaccination of bioCSL’s influenza virus vaccine after 1 July 2014.
• Age groups:
  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)
• Special population of interest:
  Immunocompromised

  Pregnant women
• Estimated number of subjects:
  400

Study design details

• Main study objective:
  1st: To characterise the reactogenicity (local, systemic and allergic reactions) within 7days after each influenza vaccination with bioCSL’s influenza virus vaccine in participants routinely indicated for influenza vaccination in specified age groups.2nd: To assess frequency & severity of medically attended adverse events with initial symptom onset within 7days after vaccination.
• Outcomes:
  The reactogenicity of bioCSL’s influenza virus vaccine will be assessed in the vaccinated cohort by summarising reports of solicited AEs occurring within 7days after each vaccination. Solicited events include injection site, systemic and allergic reactions in all age groups. Participants will also be asked to indicate if they did not experience any AEs, to distinguish between no report reported AE, Information on medically attended AEs will be recorded for medical attendances that relate to events where the symptoms relating to the reason for medical attendance started within seven days after each influenza vaccination, even if the first attendance occurred outside the seven day period.
• Data analysis plan:
  Descriptive analyses (frequencies, counts, n and percentages) will provide the majority of the results, both broken down into the four age groups and overall. Additional descriptive statistics (mean, standard deviation, median, range) are provided for continuous variables.

Documents

Study results

RESULT SUMMARY for CSLCT-SAF-14-05 - Final_10Aug15