Post-marketing Safety of Elasomeran/Davesomeran and Andusomeran

NCT06130345 | Completed

• 1 other identifier: mRNA-1273-P920
• Study Type: observational
• Target: 15,196,685
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events of Special Interest (AESI)

  Day 2 up to Day 60 after vaccination

Study Arms (2)

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

SPIKEVAX BIOLOGICAL

Intramuscular injection

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

Cohort 1: Influenza Vaccinated Concurrent Comparator; Cohort 2: Medically Attended COVID-19 Concurrent Comparator

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• ModernaTX, Inc.: lead
• Aetion, Inc.: collaborator

Study Sites (1)

Aetion, Inc

New York, New York, 10001, United States

Location

MeSH Terms

Conditions

Coronavirus Infections; Virus Diseases; COVID-19

Interventions

2019-nCoV Vaccine mRNA-1273; CVnCoV COVID-19 vaccine

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 14, 2023
• Study Start: April 14, 2023
• Primary Completion: February 29, 2024
• Study Completion: August 31, 2024
• Last Updated: December 19, 2024

Record last verified: 2024-12

Locations

US (1)