Post-marketing Safety of Elasomeran/Davesomeran and Andusomeran Vaccines in the United States

mRNA-1273-P920

The main objective of the study is to evaluate the safety of the elasomeran/davesomeran and andusomeran vaccines as used in routine clinical practice.

2023-04-14

2024-02-29

2024-09-15

Active (not recruiting)

10000000

Inclusion Criteria: Cohort 1: Influenza vaccinated concurrent comparator Eligible vaccine episodes must meet the following inclusion criteria within the protocol-specified time windows: * Non-missing sex: (start of available data, 1 day prior to index) * No receipt of elasomeran/davesomeran and andusomeran vaccine: (90 days prior to index, 1 day prior to index) * No receipt of influenza vaccine: (90 days prior to index, 1 day prior to index) * No receipt of any other COVID-19 vaccine: (90 days prior to index, index date) * Continuous enrollment in closed medical and pharmacy claims (365 days prior to index, index date) Cohort 2: Medically attended COVID-19 concurrent comparator Eligible vaccine and disease episodes must meet the following inclusion criteria within the specified time windows: * Non-missing sex: (start of available data, 1 day prior to index) * No receipt of elasomeran/davesomeran and andusomeran vaccine: (180 days prior to index, 1 day prior to index) * No evidence of medically attended COVID-19: (180 days prior to index, 1 day prior to index) * No receipt of any other COVID-19 vaccine: (180 days prior to index, index date) * Continuous enrollment in closed medical and pharmacy claims (365 days prior to index, index date) Exclusion Criteria: * Vaccine and disease episodes with a prior AESI within the washout window will be excluded from the analytic cohort. * For the influenza vaccinated concurrent comparator cohort, individuals who receive an elasomeran/davesomeran and andusomeran vaccine and an influenza vaccine on the same day or within a minimum number of days will be excluded from the primary analysis. Note: Other protocol-defined inclusion/exclusion criteria may apply.

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 10000000, 'type': 'ESTIMATED'}}

2024-04-02