SARS-CoV-2NCT06130345
Post-marketing Safety of Elasomeran/Davesomeran and Andusomeran
An observational study of SARS-CoV-2, run by ModernaTX, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2
- What is being tested?
- SPIKEVAX
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 15,196,685 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2023to 31 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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)
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- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Post-marketing Safety of Elasomeran/Davesomeran and Andusomeran Vaccines in the United States
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
- Being tested
- SPIKEVAX
- Keywords
- Elasomeran, Davesomeran, Andusomeran, SARS-CoV-2, SARS-CoV-2 Vaccine, Coronavirus, Virus Diseases, Messenger RNA, COVID-19, COVID-19 Vaccine, Moderna
- Medical subject headings
- Coronavirus Infections, Virus Diseases, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPIKEVAXBiological
Also called SARS-CoV-2-mRNA vaccine, SPIKEVAX Bivalent, Spikevax XBB.1.5, Elasomeran
Intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: SPIKEVAX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events of Special Interest (AESI)
Measured: Day 2 up to Day 60 after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start14 Apr 2023
- Primary completion29 Feb 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- More trials run by ModernaTX, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 15,196,685 participants (actual)
Sponsor and investigators
- Lead sponsor
- ModernaTX, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aetion, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06130345
- Sponsor's protocol ID
- mRNA-1273-P920
- Status last verified
- Dec 2024
- First submitted
- 8 Nov 2023
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Safety of Elasomeran/Davesomeran and Andusomeran Vaccines in the United States
- ClinicalTrials.gov ID
- NCT06130345
- Acronym / sponsor ID
- mRNA-1273-P920
- Conditions
- SARS-CoV-2
- Keywords
- Elasomeran, Davesomeran, Andusomeran, SARS-CoV-2, SARS-CoV-2 Vaccine, Coronavirus, Virus Diseases, Messenger RNA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15,196,685 participants (actual)
- Lead sponsor
- ModernaTX, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Aetion, Inc.
- Study start
- 14 Apr 2023 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 14 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of the study is to evaluate the safety of the elasomeran/davesomeran and andusomeran vaccines as used in routine clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Influenza Vaccinated Concurrent Comparator | – | Biological: SPIKEVAXParticipants 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. |
| Cohort 2: Medically Attended COVID-19 Concurrent Comparator | – | Biological: SPIKEVAXParticipants 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (14 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPIKEVAXAlso: SARS-CoV-2-mRNA vaccine, SPIKEVAX Bivalent, Spikevax XBB.1.5, ElasomeranIntramuscular injection | Biological | Cohort 1: Influenza Vaccinated Concurrent Comparator, Cohort 2: Medically Attended COVID-19 Concurrent Comparator |
Primary outcome
Number of Participants With Adverse Events of Special Interest (AESI)
Time frame: Day 2 up to Day 60 after vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV-2, run by ModernaTX, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events of Special Interest (AESI) (time frame: Day 2 up to Day 60 after vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2024; AzTrials last refreshed its copy on 8 Nov 2026.