SARS-CoV-2 VACCINATION for COVID-19 DISEASE SAFETY STUDY (VAC4COVID STUDY)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Prescription event monitoring, post-authorisation cohort safety study (PASS)

Population studied

• 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)
• Estimated number of subjects:
  20000

Study design details

• Main study objective:
  To examine the use and safety of licensed/authorised COVID-19 vaccination by collecting event data from participants and healthcare professionals before, during and after the vaccination programme. To monitor, detect and report early pre-specified and emergent safety signals in relation to licensed/authorised COVID-19 vaccinations.
• Outcomes:
  Recruit consented cohorts of participants to examine the safety of licensed/authorised COVID-19 vaccinations. Outcomes measures: Number of participants offered vaccination Number of participants vaccinated Numbers and rates of SAEs and AESI occurring in vaccinated and non-vaccinated participants, Collect participant self-reported data via questionnaires using electronic data capture. Collect demographics of vaccinated and unvaccinated (unexposed) participants. Collect demographics of vaccinated and unvaccinated (unexposed) participants. Collate and analyse licensed/authorised vaccine utilisation characteristics for the whole vaccinated cohort.
• Data analysis plan:
  We will conduct frequent interim analyses (at intervals to be determined in collaboration with medicines safety regulators) to detect signals in the data as it accumulates (Phase 1), and further, more detailed analyses when the study is complete (Phase 2). For each primary outcome we will plot cumulative hazards (-log(survival rate), with confidence intervals) for: vaccinated patients, with date of vaccination as time 0, and unvaccinated patients, with date of recruitment as time 0 and censored at vaccination. We will also plot the cumulative hazards based on an external estimate of population incidence rates (a straight line).

Documents

Study, other information

VAC4COVID Advisory Committee Charter v1 (e-signed 22-02-21)