Post-marketing Safety of Elasomeran/Davesomeran and Andusomeran

Completed

Conditions studied: SARS-CoV-2

In brief

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

Key facts

Study ID

NCT06130345

Run by

ModernaTX, Inc.

People needed

15196685

Starts

2023-04-14

Expected to finish

2024-08-31

Last updated by the study team

2024-12-19

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• Aetion, Inc — New York, New York, United States

Full record on ClinicalTrials.gov

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