Post-marketing Safety of Elasomeran/Davesomeran and Andusomeran

December 17, 2024 updated by: ModernaTX, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

15196685

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10001
        • Aetion, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population will be identified using HealthVerity's aggregated medical and pharmacy claims database between September 1, 2022 and February 29, 2024.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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:
  • Elasomeran
  • Davesomeran
  • SARS-CoV-2-mRNA vaccine
  • SPIKEVAX Bivalent
  • Spikevax XBB.1.5
  • 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:
  • Elasomeran
  • Davesomeran
  • SARS-CoV-2-mRNA vaccine
  • SPIKEVAX Bivalent
  • Spikevax XBB.1.5
  • Andusomeran

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ModernaTX, Inc.

Collaborators

Aetion, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2023

Primary Completion (Actual)

February 29, 2024

Study Completion (Actual)

August 31, 2024

Study Registration Dates

First Submitted

November 8, 2023

First Submitted That Met QC Criteria

November 8, 2023

First Posted (Actual)

November 14, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 17, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mRNA-1273-P920

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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