Status:
COMPLETED
Post-marketing Safety of Elasomeran/Davesomeran and Andusomeran
Lead Sponsor:
ModernaTX, Inc.
Collaborating Sponsors:
Aetion, Inc.
Conditions:
SARS-CoV-2
Eligibility:
All Genders
Brief Summary
The main objective of the study is to evaluate the safety of the elasomeran/davesomeran and andusomeran vaccines as used in routine clinical practice.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 14 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 31 2024
Estimated Enrollment :
15196685 Patients enrolled
Trial Details
Trial ID
NCT06130345
Start Date
April 14 2023
End Date
August 31 2024
Last Update
December 19 2024
Active Locations (1)
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1
Aetion, Inc
New York, New York, United States, 10001