Safety Profile of the NVX-CoV2373 Vaccine in Individuals ≥ 12 Years of Age in the United States

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 case series

Study drug and medical condition

• Name of medicine, other:
  COVID-19 VACCINE (RECOMBINANT, ADJUVANTED)
• Study drug International non-proprietary name (INN) or common name:
  COVID-19 VACCINE (RECOMBINANT, ADJUVANTED)
• Medical condition to be studied:
  Immunodeficiency

  Stem cell transplant
• Additional medical condition(s):
  Immunocompromised

Population studied

• Age groups:
  • Paediatric Population (< 18 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
• Estimated number of subjects:
  24264457

Study design details

• Main study objective:
  To Evaluate the Risk of Select AESIs Following Vaccination with at Least One Dose of NVX-CoV2373 Using a Self-Controlled Design
• Outcomes:
  To Evaluate the Risk of Select AESIs Following Vaccination with at Least One Dose of NVX-CoV2373 Using a Self-Controlled Design, To Evaluate the Risk of Select AESIs Following Receipt of the First Dose of Homologous NVX-CoV2373 Primary Series Using a Self-Controlled Design To Evaluate the Risk of Select AESIs Following Completion of a Homologous NVX-CoV2373 Two-Dose Primary Series (Receipt of the Second Dose) Using a Self-Controlled Design
• Data analysis plan:
  All study objectives (primary, secondary, and exploratory) will only utilize closed claims data to ensure we fully capture the individual's interactions with the healthcare system. Furthermore, for each AESI, if the number of outcome events are not large enough for analysis to be adequately powered, only descriptive analysis will be performed.