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CompletedNCT06130345Updated Dec 19, 2024

Post-marketing Safety of Elasomeran/Davesomeran and Andusomeran

An observational study in SARS-CoV-2, sponsored by ModernaTX, Inc.. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2024-12-19.

Sponsored by ModernaTX, Inc. (part of Moderna, Inc.) · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
15,196,685
Sex
All
01

Study 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.

02

Conditions studied

  • SARS-CoV-2

Keywords

  • Elasomeran
  • Davesomeran
  • Andusomeran
  • SARS-CoV-2
  • SARS-CoV-2 Vaccine
  • Coronavirus
  • Virus Diseases
  • Messenger RNA
  • COVID-19
  • COVID-19 Vaccine
  • Moderna
03

In context

Coronavirus Infections

952 studies on the registry are indexed under Coronavirus Infections; 50 are open to participants now.

This study's enrollment of 15,196,685 is above the median of 300 across 348 observational studies indexed under Coronavirus Infections.

Browse Coronavirus Infections studies →

Lead sponsor

ModernaTX, Inc. is the lead sponsor of 117 studies on the registry; 16 are open to participants now.

Of its 63 completed or terminated interventional studies of FDA-regulated products, 35 (56%) have results posted.

Browse ModernaTX, Inc. studies →All Moderna, Inc. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
15,196,685 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • 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

Interventions

  • BiologicalSPIKEVAX

    Intramuscular injection

    Also known as: SARS-CoV-2-mRNA vaccine, SPIKEVAX Bivalent, Spikevax XBB.1.5, Elasomeran, Davesomeran, Andusomeran

06

What researchers measure

Primary outcomes

  1. Number of Participants With Adverse Events of Special Interest (AESI)

    Time frame: Day 2 up to Day 60 after vaccination

07

Study locations

1 site
  • Aetion, Inc
    New York, New York 10001, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2023 to primary completion in Feb 2024, 10 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 8, 2023
First posted
Nov 14, 2023
StartActual
Apr 14, 2023
Primary completionActual
Feb 29, 2024
CompletionActual
Aug 31, 2024
Last update
Dec 19, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06130345
Lead sponsor
ModernaTX, Inc.
Collaborators
Aetion, Inc.
Responsible party
Sponsor
First posted
Nov 14, 2023
Start date
Apr 14, 2023
Primary completion
Feb 29, 2024
Completion
Aug 31, 2024
Last update
Dec 19, 2024

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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