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Post-marketing Safety of Elasomeran/Davesomeran and Andusomeran

NCT ID: NCT06130345

Last Updated: 2024-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15196685 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-14

Study Completion Date

2024-08-31

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.

Detailed Description

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Conditions

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SARS-CoV-2

Keywords

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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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

SPIKEVAX

Intervention Type BIOLOGICAL

Intramuscular injection

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.

SPIKEVAX

Intervention Type BIOLOGICAL

Intramuscular injection

Interventions

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SPIKEVAX

Intramuscular injection

Intervention Type BIOLOGICAL

Other Intervention Names

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SARS-CoV-2-mRNA vaccine SPIKEVAX Bivalent Spikevax XBB.1.5 Elasomeran Davesomeran Andusomeran

Eligibility Criteria

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Inclusion Criteria

Cohort 1: Influenza vaccinated concurrent comparator


* 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


* 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aetion, Inc.

OTHER

Sponsor Role collaborator

ModernaTX, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Aetion, Inc

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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mRNA-1273-P920

Identifier Type: -

Identifier Source: org_study_id