An Observational Post-Authorization Safety Study to Assess the Safety of Ad26.COV2.S Using European Healthcare Data through VAC4EU (COVID-19)

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Self-Controlled Risk Interval

Study drug and medical condition

• Medical condition to be studied:
  Guillain-Barre syndrome
• Additional medical condition(s):
  Not exhaustive list

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:
  370000

Study design details

• Main study objective:
  This study has 2 chronologically consecutive aims: 1) to conduct a feasibility assessment aiming to inform the safety evaluation study and 2) to assess the risk of developing pre-specified and newly identified AESIs following administration of Ad26.COV2.S.
• Outcomes:
  predefined and newly identified AESIs among individuals exposed to Ad26.COV2.S
• Data analysis plan:
  For the feasibility analysis the utilization patterns of Ad26.COV2.S and other COVID-19 vaccines will be characterized and monitored over time. The primary analysis will focus on the calculation and comparison of the incidence rates of each non-acute AESI between individuals exposed to Ad26.COV2.S and (1) unexposed individuals, (2) individuals exposed to another viral vector COVID-19 vaccine (ie, Vaxzevria® AZD1222 byOxford/AstraZeneca), and 3) individuals exposed receiving a mRNA COVID-19 vaccine (cohort).For acute events, the relative risk between risk window and control window will be estimated(SCRI) among individuals exposed to Ad26.COV2.S.