SARS-CoV-2NCT04958954
Post-Marketing Safety Study of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) mRNA-1273 COVID-19 Vaccine in the United States
An observational study of SARS-CoV-2, run by ModernaTX, Inc. at 1 site in United States.
Trial summary
The goal of this study is to add to the ongoing active and passive safety signal detection through signal refinement and, if needed, evaluation of potential safety signals related to taking the SARS-CoV-2 mRNA-1273 vaccine. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2
- Type of treatment
- Vaccines
- How many people
- 50,000,000 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2021to 30 Jun 2023
- 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 selected from HealthVerity's aggregated medical and pharmacy claims database that represents healthcare utilization for over 140 million participants between 01 December 2017 and the end of the study period (31 December 2022).
Who may be able to join
- Included in a health plan covered by HealthVerity database
- Covered by a health plan during at least 1 period of interest (pre-COVID-19, active-COVID-19, and post-EUA periods), but not necessarily the full period.
- Demonstrate an AESI specified clean period of continuous baseline enrollment or activity before the period of interest (pre-COVID-19, active-COVID-19, and post-EUA periods) during which the participant is covered.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-Marketing Safety of SARS-CoV-2 mRNA-1273 Vaccine in the US: Active Surveillance, Signal Refinement and Self-Controlled Risk Interval (SCRI) Signal Evaluation in HealthVerity
The goal of this study is to add to the ongoing active and passive safety signal detection through signal refinement and, if needed, evaluation of potential safety signals related to taking the SARS-CoV-2 mRNA-1273 vaccine.
Read the detailed description
This retrospective observational cohort study will use secondary, de-identified individual-level medical and pharmacy claims data provided by HealthVerity.
- Conditions
- SARS-CoV-2
- Keywords
- mRNA-1273, mRNA-1273 vaccine, 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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1a: Pre-COVID | All participants meeting eligibility criteria in the Pre-COVID-19 period (immediately preceding the emergence of COVID-19) (Time Period 1) from 01 December 2018 to 30 November 2019 | |
| Cohort 1b: Pre-COVID | All participants with evidence of an influenza vaccination and meeting eligibility criteria in the Pre-COVID-19 period (immediately preceding the emergence of COVID-19) (Time Period 1) from 01 December 2018 to 30 November 2019 | |
| Cohort 2: Active-COVID | All participants meeting eligibility criteria in the Active-COVID-19 period, Pre-Emergency Use Authorization (EUA) period (following the emergence of COVID-19 but before the first COVID-19 vaccine EUA) (Time Period 2) from 01 December 2019 to 10 December 2020 (1 day prior to first United States SARS-CoV-2 vaccine EUA) | |
| Cohort 3: Post-EUA | All mRNA-1273 vaccinated participants meeting eligibility criteria in the Post-EUA period (Time Period 3) from date of first United States SARS-CoV-2 vaccine EUA to 31 December 2022 |
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 Interests (AESIs)
Measured: Index date (that is, first day of health plan eligibility within the applicable time period where all study entry criteria are met) through end of data availability or earliest event (maximum of 751 days depending on duration of capture in the database)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start7 Jul 2021
- Primary completion31 Aug 2022
- Study completion30 Jun 2023
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
- 50,000,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- ModernaTX, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04958954
- Sponsor's protocol ID
- mRNA-1273-P903
- Other IDs
- EUPAS41392
- Status last verified
- Jul 2023
- First submitted
- 9 Jul 2021
- Last updated
- 17 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Safety of SARS-CoV-2 mRNA-1273 Vaccine in the US: Active Surveillance, Signal Refinement and Self-Controlled Risk Interval (SCRI) Signal Evaluation in HealthVerity
- ClinicalTrials.gov ID
- NCT04958954
- Acronym / sponsor ID
- mRNA-1273-P903
- Conditions
- SARS-CoV-2
- Keywords
- mRNA-1273, mRNA-1273 vaccine, SARS-CoV-2, SARS-CoV-2 Vaccine, Coronavirus, Virus Diseases, Messenger RNA, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50,000,000 participants (actual)
- Lead sponsor
- ModernaTX, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 12 Jul 2021 (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 goal of this study is to add to the ongoing active and passive safety signal detection through signal refinement and, if needed, evaluation of potential safety signals related to taking the SARS-CoV-2 mRNA-1273 vaccine.
Detailed description
This retrospective observational cohort study will use secondary, de-identified individual-level medical and pharmacy claims data provided by HealthVerity.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1a: Pre-COVID | – | –All participants meeting eligibility criteria in the Pre-COVID-19 period (immediately preceding the emergence of COVID-19) (Time Period 1) from 01 December 2018 to 30 November 2019 |
| Cohort 1b: Pre-COVID | – | –All participants with evidence of an influenza vaccination and meeting eligibility criteria in the Pre-COVID-19 period (immediately preceding the emergence of COVID-19) (Time Period 1) from 01 December 2018 to 30 November 2019 |
| Cohort 2: Active-COVID | – | –All participants meeting eligibility criteria in the Active-COVID-19 period, Pre-Emergency Use Authorization (EUA) period (following the emergence of COVID-19 but before the first COVID-19 vaccine EUA) (Time Period 2) from 01 December 2019 to 10 December 2020 (1 day prior to first United States SARS-CoV-2 vaccine EUA) |
| Cohort 3: Post-EUA | – | –All mRNA-1273 vaccinated participants meeting eligibility criteria in the Post-EUA period (Time Period 3) from date of first United States SARS-CoV-2 vaccine EUA to 31 December 2022 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will be selected from HealthVerity's aggregated medical and pharmacy claims database that represents healthcare utilization for over 140 million participants between 01 December 2017 and the end of the study period (31 December 2022).
Key inclusion criteria (3 listed)
- Included in a health plan covered by HealthVerity database
- Covered by a health plan during at least 1 period of interest (pre-COVID-19, active-COVID-19, and post-EUA periods), but not necessarily the full period.
- Demonstrate an AESI specified clean period of continuous baseline enrollment or activity before the period of interest (pre-COVID-19, active-COVID-19, and post-EUA periods) during which the participant is covered.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants With Adverse Events of Special Interests (AESIs)
Time frame: Index date (that is, first day of health plan eligibility within the applicable time period where all study entry criteria are met) through end of data availability or earliest event (maximum of 751 days depending on duration of capture in the database)
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 17 Jul 2023.
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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 3 inclusion and 1 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 17 Jul 2023. 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 Interests (AESIs) (time frame: Index date (that is, first day of health plan eligibility within the applicable time period where all study entry criteria are met) through end of data availability or earliest event (maximum of 751 days depending on duration of capture in the database)). 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 17 Jul 2023.