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

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

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.