Post-marketing Safety of Elasomeran/Davesomeran and Andusomeran

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

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

Conditions
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SARS-CoV-2

Intervention / Treatment
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* Biological: SPIKEVAX


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1: Influenza Vaccinated Concurrent Comparator<br>Participants who receive an elasomeran/davesomeran or an andusomeran vaccine in routine clinical practice are compared to participants who receive an influenza vaccine to observe differences in the rate of adverse events of special interest during an etiologically relevant window. | Biological: SPIKEVAX<br>* Intramuscular injection<br>* Other names: Andusomeran;|
| Cohort 2: Medically Attended COVID-19 Concurrent Comparator<br>Participants who receive an elasomeran/davesomeran or an andusomeran vaccine in routine clinical practice are compared to participants who diagnosed with COVID-19 to observe differences in in the rate of adverse events of special interest during an etiologically relevant window. | Biological: SPIKEVAX<br>* Intramuscular injection<br>* Other names: Andusomeran;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events of Special Interest (AESI) |  | Day 2 up to Day 60 after vaccination | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elasomeran, Davesomeran, Andusomeran, SARS-CoV-2, SARS-CoV-2 Vaccine, Coronavirus, Virus Diseases, Messenger RNA, COVID-19, COVID-19 Vaccine, Moderna