Post-marketing Safety of Elasomeran/Davesomeran and Andusomeran

SARS-CoV-2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06130345
• Other study ID #: mRNA-1273-P920
• Status: Active, not recruiting
• Start date: April 14, 2023
• Est. completion date: September 15, 2024

Study information

• Verified date: March 2024
• Source: ModernaTX, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10000000
• Est. completion date: September 15, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• SARS-CoV-2

Intervention

Biological:
• SPIKEVAX
Intramuscular injection

Locations

Country	Name	City	State
United States	Aetion, Inc	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
ModernaTX, Inc.	Aetion, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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