Post-marketing Safety of Elasomeran/Davesomeran and Andusomeran

Sponsor

ModernaTX, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT06130345

Collaborator

Aetion, Inc. (Other)

10,000,000

Enrollment

Location

17.1

Anticipated Duration (Months)

585336.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
SARS-CoV-2	Biological: SPIKEVAX

Study Design

Study Type:

Observational

Anticipated Enrollment :

10000000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Apr 14, 2023

Anticipated Primary Completion Date :

Feb 29, 2024

Anticipated Study Completion Date :

Sep 15, 2024

Arms and Interventions

Arm	Intervention/Treatment
Cohort 1: Influenza Vaccinated Concurrent Comparator 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 Intramuscular injection Other Names: SARS-CoV-2-mRNA vaccine SPIKEVAX Bivalent Spikevax XBB.1.5 Elasomeran Davesomeran Andusomeran
Cohort 2: Medically Attended COVID-19 Concurrent Comparator 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 Intramuscular injection Other Names: SARS-CoV-2-mRNA vaccine SPIKEVAX Bivalent Spikevax XBB.1.5 Elasomeran Davesomeran Andusomeran

Arm

Intervention/Treatment

Cohort 1: Influenza Vaccinated Concurrent Comparator

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

Intramuscular injection

Other Names:

SARS-CoV-2-mRNA vaccine

SPIKEVAX Bivalent

Spikevax XBB.1.5

Elasomeran

Davesomeran

Andusomeran

Cohort 2: Medically Attended COVID-19 Concurrent Comparator

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

Intramuscular injection

Other Names:

SARS-CoV-2-mRNA vaccine

SPIKEVAX Bivalent

Spikevax XBB.1.5

Elasomeran

Davesomeran

Andusomeran

Outcome Measures

Primary Outcome Measures

Number of Participants With Adverse Events of Special Interest (AESI) [Day 2 up to Day 60 after vaccination]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.