Study type

Study type

Non-interventional study
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(J07BN01) covid-19, RNA-based vaccine
covid-19, RNA-based vaccine
Population studied

Age groups

Infants and toddlers (28 days – 23 months)
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

1
Study design details

Main study objective

To estimate the incidence of pre-specified safety events of interest following vaccination with the COMIRNATY 2023-2024 Formula compared to the incidence of these events during a control window (i.e. expected rates of these events).

Data analysis plan

For the phase 1 SCRI design, the observed incidence rates of the pre-specified safety outcomes of interest will be estimated in the risk window and the control window. Among individuals who experience an outcome of interest, an exact conditional Poisson regression model with the natural logarithm of the person-time as the offset will be used to calculate the rate ratio and corresponding 95% confidence interval (CI) of events occurring during the risk period relative to the control period. The results from the SCRI utilizing the Optum pre-adjudicated claims database will be presented in the interim report, while results utilizing the ORD will be presented in the final report. Please see the protocol for a description of the data analysis plan for the phase 2 cohort study.