Safety of the Novavax COVID-19 vaccine in England using a self-controlled case series design: A post-authorisation safety study using data from the Clinical Practice Research Datalink (CPRD) Aurum and linked databases

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:
  Other
• Non-interventional study design, other:
  Self-controlled case series

Study drug and medical condition

• Name of medicine:
  NUVAXOVID

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:
  10686

Study design details

• Main study objective:
  To evaluate the risk of select AESI following vaccination with the NuvaxovidTM vaccine using a self-controlled case series design.
• Outcomes:
  The risk of select AESI following vaccination with any dose of NuvaxovidTM vaccine. The risk of select AESI following vaccination with NuvaxovidTM vaccine after receipt of a first dose, completion of a two-dose primary series, receipt of a booster dose, and among subgroups of interest after any dose.
• Data analysis plan:
  The primary and secondary objectives will be analyzed using Conditional Poisson regression modelling to estimate incident rate ratios for each AESI.