SARS-CoV-2NCT05933304
A Study of the Effectiveness of Moderna COVID-19 Vaccine
An observational study of SARS-CoV-2 and COVID-19, run by ModernaTX, Inc. at 1 site in United States.
Trial summary
This is an observational cohort study to evaluate real-world vaccine effectiveness and durability of Moderna COVID-19 vaccine among a diverse population at Kaiser Permanente Southern California (KPSC). Read more about this study
- Who is it for?
- Ages 6 months and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2, COVID-19
- Type of treatment
- Vaccines
- How many people
- 927,004 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2020to 17 Nov 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 6 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants vaccinated with Moderna COVID-19 vaccine and unvaccinated participants are included in this study.
Who may be able to join
- Aged ≥18 years at index date (participants aged 6 months through 17 years will also be included after Food and Drug Administration [FDA] authorization to vaccinate younger age groups)
- KPSC member for ≥12 months prior to index date through 14 days after the index date (allowing a 31-day gap)
Who cannot join
- Receipt of a COVID-19 vaccine other than Moderna COVID-19 vaccine prior to or on the index date
- Receipt of 2 doses of Moderna COVID-19 vaccine <24 days apart for 2-dose exposed cohort
- Receipt of any COVID-19 vaccine <14 days after the index date
- No health care utilization and no vaccination from the 2 years prior to the index date through the index date
- Occurrence of a COVID-19 outcome <14 days after the index date
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Southern California
Pasadena, California, 91101
About this study
Official title: Real-World Study of the Effectiveness of Moderna COVID-19 Vaccine
This is an observational cohort study to evaluate real-world vaccine effectiveness and durability of Moderna COVID-19 vaccine among a diverse population at Kaiser Permanente Southern California (KPSC).
The primary objective of this study is to evaluate the vaccine effectiveness (VE) of receipt of Moderna COVID-19 vaccine in preventing SARS-CoV-2 infection and severe COVID-19 disease.
SARS-CoV-2 infection will be defined as a positive antigen test result as well as a positive molecular diagnostic test among symptomatic or asymptomatic participants or a COVID-19 diagnosis code. Severe COVID-19 disease will be defined as COVID-19 hospitalization or mortality.
Read the detailed description
This study utilized electronic healthcare data collected within the Kaiser Permanente Southern California (KPSC) integrated healthcare system which provides care to over 4.6 million individuals. Participants in this study received vaccination and were assessed for study outcomes as part of routine care. Vaccination information and study outcome status was assessed using procedure, diagnostic, and laboratory code information. Medical chart review was conducted to assess the association of severe outcomes (hospitalization and death) with COVID-19 illness.
Analyses assessing absolute vaccine effectiveness will identify participants who receive Moderna COVID vaccine from the KPSC electronic healthcare database and match them to unvaccinated participants based on age, sex, race/ethnicity, and data of vaccination (index date). Vaccinated and unvaccinated participants will then be followed-up in the database for the occurrence of study outcomes. Cox proportional hazards regression will be used to compare the relative risk of study outcomes by vaccination status.
Analyses of relative vaccine effectiveness will identify participants who receive specific dose number and formulation of Moderna COVID vaccine (Group N) from the KPSC electronic healthcare database and match them to a group of vaccinated participants with a different dose/formulation type (i.e. Group n-1). Similar matching criteria will be applied. Both groups will be followed for study outcomes and cox proportional hazards regression will be used to compare the relative risk of study outcomes by vaccination status.
- Conditions
- SARS-CoV-2, COVID-19
- Medical subject headings
- 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 |
|---|---|---|
| Vaccinated Cohort | Participants who receive Moderna COVID-19 vaccine during a pre-specified time frame and meet eligibility criteria will be included in this cohort. Participants will be followed up through Electronic Health Record (EHR) for occurrence of COVID-19 outcomes until the end of the study period, or censoring events (termination of KPSC membership allowing for a 31-day gap, death, receipt of a COVID-19 vaccine). | |
| Unexposed Cohort | Participants in this cohort include: * Participants who had not received any bivalent dose but had received at least 2 doses of monovalent mRNA COVID-19 vaccine by the index date * Participants who never received any COVID-19 vaccine dose by the index date Participants will be followed up through EHR for occurrence of COVID-19 outcomes until the end of the study period, or censoring events (termination of KPSC membership allowing for a 31-day gap, death, receipt of a COVID-19 vaccine). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With SARS-CoV-2 Infection
SARS-CoV-2 infection is defined as a positive antigen test result as well as a positive molecular test or a COVID-19 diagnosis code.
Measured: Up to 3 years
Number of Participants With Severe COVID-19 Disease
Severe COVID-19 disease includes COVID-19 hospitalization (hospitalization with a SARS-CoV-2 positive test or a COVID-19 diagnosis, or a hospitalization occurring ≤7 days after a SARS-CoV-2 positive test, with chart review to confirm severe COVID-19 symptoms) and COVID-19 mortality (death during COVID-19 hospitalization).
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start18 Dec 2020
- Primary completion17 Nov 2023
- Study completion17 Nov 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
- 927,004 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
- NCT05933304
- Sponsor's protocol ID
- mRNA-1273-P901
- Status last verified
- May 2025
- First submitted
- 5 Jul 2023
- Last updated
- 28 May 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Study of the Effectiveness of Moderna COVID-19 Vaccine
- ClinicalTrials.gov ID
- NCT05933304
- Acronym / sponsor ID
- mRNA-1273-P901
- Conditions
- SARS-CoV-2, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 927,004 participants (actual)
- Lead sponsor
- ModernaTX, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Dec 2020 (actual)
- Primary completion
- 17 Nov 2023 (actual)
- Study completion
- 17 Nov 2023 (actual)
- First posted
- 6 Jul 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.
This is an observational cohort study to evaluate real-world vaccine effectiveness and durability of Moderna COVID-19 vaccine among a diverse population at Kaiser Permanente Southern California (KPSC).
The primary objective of this study is to evaluate the vaccine effectiveness (VE) of receipt of Moderna COVID-19 vaccine in preventing SARS-CoV-2 infection and severe COVID-19 disease.
SARS-CoV-2 infection will be defined as a positive antigen test result as well as a positive molecular diagnostic test among symptomatic or asymptomatic participants or a COVID-19 diagnosis code. Severe COVID-19 disease will be defined as COVID-19 hospitalization or mortality.
Detailed description
This study utilized electronic healthcare data collected within the Kaiser Permanente Southern California (KPSC) integrated healthcare system which provides care to over 4.6 million individuals. Participants in this study received vaccination and were assessed for study outcomes as part of routine care. Vaccination information and study outcome status was assessed using procedure, diagnostic, and laboratory code information. Medical chart review was conducted to assess the association of severe outcomes (hospitalization and death) with COVID-19 illness.
Analyses assessing absolute vaccine effectiveness will identify participants who receive Moderna COVID vaccine from the KPSC electronic healthcare database and match them to unvaccinated participants based on age, sex, race/ethnicity, and data of vaccination (index date). Vaccinated and unvaccinated participants will then be followed-up in the database for the occurrence of study outcomes. Cox proportional hazards regression will be used to compare the relative risk of study outcomes by vaccination status.
Analyses of relative vaccine effectiveness will identify participants who receive specific dose number and formulation of Moderna COVID vaccine (Group N) from the KPSC electronic healthcare database and match them to a group of vaccinated participants with a different dose/formulation type (i.e. Group n-1). Similar matching criteria will be applied. Both groups will be followed for study outcomes and cox proportional hazards regression will be used to compare the relative risk of study outcomes by vaccination status.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccinated Cohort | – | –Participants who receive Moderna COVID-19 vaccine during a pre-specified time frame and meet eligibility criteria will be included in this cohort. Participants will be followed up through Electronic Health Record (EHR) for occurrence of COVID-19 outcomes until the end of the study period, or censoring events (termination of KPSC membership allowing for a 31-day gap, death, receipt of a COVID-19 vaccine). |
| Unexposed Cohort | – | –Participants in this cohort include: * Participants who had not received any bivalent dose but had received at least 2 doses of monovalent mRNA COVID-19 vaccine by the index date * Participants who never received any COVID-19 vaccine dose by the index date Participants will be followed up through EHR for occurrence of COVID-19 outcomes until the end of the study period, or censoring events (termination of KPSC membership allowing for a 31-day gap, death, receipt of a COVID-19 vaccine). |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants vaccinated with Moderna COVID-19 vaccine and unvaccinated participants are included in this study.
Key inclusion criteria (2 listed)
- Aged ≥18 years at index date (participants aged 6 months through 17 years will also be included after Food and Drug Administration [FDA] authorization to vaccinate younger age groups)
- KPSC member for ≥12 months prior to index date through 14 days after the index date (allowing a 31-day gap)
Key exclusion criteria (5 listed)
- Receipt of a COVID-19 vaccine other than Moderna COVID-19 vaccine prior to or on the index date
- Receipt of 2 doses of Moderna COVID-19 vaccine <24 days apart for 2-dose exposed cohort
- Receipt of any COVID-19 vaccine <14 days after the index date
- No health care utilization and no vaccination from the 2 years prior to the index date through the index date
- Occurrence of a COVID-19 outcome <14 days after the index date
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 SARS-CoV-2 Infection
Time frame: Up to 3 years
SARS-CoV-2 infection is defined as a positive antigen test result as well as a positive molecular test or a COVID-19 diagnosis code.
Number of Participants With Severe COVID-19 Disease
Time frame: Up to 3 years
Severe COVID-19 disease includes COVID-19 hospitalization (hospitalization with a SARS-CoV-2 positive test or a COVID-19 diagnosis, or a hospitalization occurring ≤7 days after a SARS-CoV-2 positive test, with chart review to confirm severe COVID-19 symptoms) and COVID-19 mortality (death during COVID-19 hospitalization).
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 28 May 2025.
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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 and COVID-19, 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 2 inclusion and 5 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 28 May 2025. 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 SARS-CoV-2 Infection (time frame: Up to 3 years). The study lists 2 primary outcomes in all. 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 28 May 2025.