Effectiveness of the Novavax COVID-19 Vaccine in Reducing Clinically Defined Severe SARS-CoV-2 Infection in Individuals ≥ 12 Years of Age in the United States

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Name of medicine, other:
  Novavax

Population studied

• Age groups:
  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:
  10

Study design details

• Main study objective:
  1.1: Assess the annual seasonal effectiveness of a two-dose primary Novavax COVID-19 vaccine series in reducing COVID-19-associated hospitalizations compared to unvaccinated individuals. 1.2: Assess the annual seasonal effectiveness of a Novavax COVID-19 vaccine booster dose in reducing COVID-19-associated hospitalization, compared to individuals eligible to receive a booster but not received o
• Outcomes:
  COVID-19 associated hospitalization, COVID-19 associated hospitalization with ICU admission
• Data analysis plan:
  Relevant descriptive and comparative analyses will be performed in either the validated AEP or R, using the most recent versions available at the time of analysis. All study objectives (Primary, Secondary, and Exploratory) will utilize only closed claims data to ensure that we have full capture of the individual’s interactions with the healthcare system.