Post-marketing Safety of Elasomeran/Davesomeran and Andusomeran

Completed

• Conditions: SARS-CoV-2
• Interventions: Biological: SPIKEVAX

• Registration Number: NCT06130345
• Lead Sponsor: ModernaTX, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-14
• Study First Submitted: 2023-11-08
• Study First Submitted QC: 2023-11-08
• Study First Posted: 2023-11-14
• Primary Completion: 2024-02-29
• Study Completion: 2024-08-31
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-17
• Last Update Posted: 2024-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15196685

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort 2: Medically Attended COVID-19 Concurrent Comparator	SPIKEVAX	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.
Cohort 1: Influenza Vaccinated Concurrent Comparator	SPIKEVAX	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events of Special Interest (AESI)	Day 2 up to Day 60 after vaccination

Trial Locations

Locations (1)

Aetion, Inc; 🇺🇸 New York, New York, United States