Post-marketing Safety of Elasomeran/Davesomeran and Andusomeran

Moderna

Status: Completed

Conditions: SARS-CoV-2

Treatments: Biological: SPIKEVAX

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06130345

mRNA-1273-P920

Details and patient eligibility

About

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

Enrollment: 15,196,685 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

15,196,685 participants in 2 patient groups

Cohort 1: Influenza Vaccinated Concurrent Comparator

Description:

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.

Treatment:

Biological: SPIKEVAX

Cohort 2: Medically Attended COVID-19 Concurrent Comparator

Description:

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.

Treatment:

Biological: SPIKEVAX