ACCESS template protocol for safety of COVID-19 vaccines

Study type

• Study topic:
  Other
• Study topic, other:
  Disease/Epidemiology study
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Retrospective multi-database dynamic study

Population studied

• Short description of the study population:
  The study included general population to determine safety of covid-19 vaccines.
• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  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)
• Special population of interest:
  Hepatic impaired

  Immunocompromised

  Pregnant women

  Renal impaired
• Estimated number of subjects:
  1000000

Study design details

• Main study objective:
  Assess the safety of COVID-19 vaccines
• Outcomes:
  All AESI
• Data analysis plan:
  Depends on the study protocol template and study implementation

Documents

Study report

EUPAS39361-39356

Study, other information

3a.Cohort-event-monitoring-to-assess-safety-of-COVID-19-vaccines-using-patient-reported-events-a-protocol-template-from-the-ACCESS-project

3b.Rapid-assessment-of-COVID-19-vaccines-safety-concerns-through-electronic-health-records-a-protocol-template-from-the-ACCESS-project-

3d.Safety-Protocol-for-Hospital-Case–Based-Monitoring-of-Specific-Adverse-Events-Following-COVID-19-Vaccines-A-Protocol-Template-from-the-ACCESS-project