Post-marketing Safety of Elasomeran/Davesomeran and Andusomeran

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06130345

Enrollment

15196685

Registered

2023-11-14

Start date

2023-04-14

Completion date

2024-08-31

Last updated

2024-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

BIOLOGICALSPIKEVAX

Intramuscular injection

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

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/

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026