SARS-CoV-2NCT05366322
A Study to Compare mRNA-1273 Versus BNT162b2 COVID-19 Vaccines Among Immunocompromised Adults
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 compare real-world effectiveness of the mRNA-1273 vaccine versus the BNT162b2 vaccine on medically attended COVID-19 and COVID-19 hospitalizations among fully vaccinated immunocompromise participants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV-2
- Type of treatment
- Vaccines
- How many people
- 124,879 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2021to 21 Mar 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- 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 participants between 01 December 2018 and 10 January 2022.
Who may be able to join
- Fully vaccinated with a currently US authorized COVID-19 vaccine:
- 2 doses of mRNA-1273 (minimum 14 days between doses)
- 2 doses of BNT1262b2 (minimum 14 days between doses)
- Continuous enrollment in medical \& pharmacy plan for at least 365 days prior to index/Cohort entry date (CED)
- Identified as immunocompromised via at least 1 of the following criteria at index/CED
- Evidence of blood or stem cell transplant in 2 years prior to index/CED
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- Any history of organ transplant and taking immunosuppressive therapy within the 60 days prior to index/CED
- Evidence of active cancer treatment in the 180 days prior to index/CED with an active cancer diagnosis in the 365 days prior to treatment
- Any prior history of a primary immunodeficiency disorder (for example, for conditions such as DiGeorge syndrome and Wiskott-Aldrich syndrome)
- Any history of an HIV diagnosis code prior to index/CED
- A fill for an immunosuppressive therapy in the 60 days prior to index/CED
Who cannot join
- Prior COVID-19 infection (any history prior to index/CED through day 13 post-completion of vaccine regimen) identified via the following diagnosis codes on an inpatient or outpatient claim:
- U07.1: "COVID-19, virus identified"
- J12.82: "Pneumonia due to COVID-19"
- Z86.16: "Personal history of COVID-19"
- The following diagnosis codes were utilized early in the pandemic. Exclusion will be applied March 1, 2020 through day 13 post-completion of vaccine regimen:
- J12.89: "Other viral pneumonia"
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- J20.8: "Acute bronchitis due to other specified organisms"
- J40: "Bronchitis, not specified as acute or chronic"
- J22: "Unspecified acute lower respiratory infection"
- J98.8: "Other specified respiratory disorders"
- J80: "Acute respiratory distress syndrome"
- Prior receipt of a heterologous COVID-19 vaccine (relative to the COVID-19 vaccine identified at index/CED) in the 365 days prior to index/CED through 13 days post-completion of vaccine regimen
- Receipt of an additional dose of homologous COVID-19 vaccine between index/CED and 13 days post-completion of vaccine regimen
- Missing or unknown gender on index/CED
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-world Comparative Effectiveness of the mRNA-1273 Vaccine vs. BNT162b2 Vaccine Among Immunocompromised Adults in the United States
The goal of this study is to compare real-world effectiveness of the mRNA-1273 vaccine versus the BNT162b2 vaccine on medically attended COVID-19 and COVID-19 hospitalizations among fully vaccinated immunocompromise participants.
Read the detailed description
This observational retrospective comparative effectiveness cohort study will use the HealthVerity aggregated medical and pharmacy claims database. HealthVerity data elements include provider-submitted claims, adjudicated insurance claims, and pharmacy billing manager claims submissions. Hospitalizations are included in the data at a summary level.
- Conditions
- SARS-CoV-2
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 A: mRNA-1273 COVID Vaccine | Participants who have received 2 doses of the mRNA-1273 vaccine at least 14 days apart. | |
| Cohort B: BNT1262b2 COVID Vaccine | Participants who have received 2 doses of the BNT1262b2 vaccine at least 14 days apart. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Medically Attended Breakthrough COVID-19 Diagnosis
Medically attended breakthrough COVID-19 diagnosis defined as a claim for COVID-19 in any setting (inpatient, outpatient, emergency room, urgent care, etc.).
Measured: Index date (14-days post-receipt of 2nd dose of mRNA-1273 to BNT162b2) up to end of available data (12 October 2021 [up to 9 months])
Secondary outcomes (1)
Number of Participants with Breakthrough Hospitalization for COVID-19
Breakthrough hospitalization for COVID-19 defined as a hospital stay for COVID-19 listed as the primary diagnosis or within 21 days prior to hospital admission.
Measured: Index date (14-days post-receipt of 2nd dose of mRNA-1273 to BNT162b2) up to end of available data (12 October 2021 [up to 9 months])
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start10 Sep 2021
- Primary completion4 Feb 2022
- Study completion21 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 124,879 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
- NCT05366322
- Sponsor's protocol ID
- mRNA-1273-P913
- Status last verified
- Apr 2022
- First submitted
- 5 May 2022
- Last updated
- 9 May 2022
- Results posted
- No
Publications
Mues KE, Kirk B, Patel DA, Gelman A, Chavers LS, Talarico CA, Esposito DB, Martin D, Mansi J, Chen X, Gatto NM, Van de Velde N. Real-world comparative effectiveness of mRNA-1273 and BNT162b2 vaccines among immunocompromised adults identified in administrative claims data in the United States. Vaccine. 2022 Nov 8;40(47):6730-6739. doi: 10.1016/j.vaccine.2022.09.025. Epub 2022 Sep 24.
PubMed 36163093
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Comparative Effectiveness of the mRNA-1273 Vaccine vs. BNT162b2 Vaccine Among Immunocompromised Adults in the United States
- ClinicalTrials.gov ID
- NCT05366322
- Acronym / sponsor ID
- mRNA-1273-P913
- Conditions
- SARS-CoV-2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124,879 participants (actual)
- Lead sponsor
- ModernaTX, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 4 Feb 2022 (actual)
- Study completion
- 21 Mar 2022 (actual)
- First posted
- 9 May 2022 (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 compare real-world effectiveness of the mRNA-1273 vaccine versus the BNT162b2 vaccine on medically attended COVID-19 and COVID-19 hospitalizations among fully vaccinated immunocompromise participants.
Detailed description
This observational retrospective comparative effectiveness cohort study will use the HealthVerity aggregated medical and pharmacy claims database. HealthVerity data elements include provider-submitted claims, adjudicated insurance claims, and pharmacy billing manager claims submissions. Hospitalizations are included in the data at a summary level.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A: mRNA-1273 COVID Vaccine | – | –Participants who have received 2 doses of the mRNA-1273 vaccine at least 14 days apart. |
| Cohort B: BNT1262b2 COVID Vaccine | – | –Participants who have received 2 doses of the BNT1262b2 vaccine at least 14 days apart. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 participants between 01 December 2018 and 10 January 2022.
Key inclusion criteria (11 listed)
- Fully vaccinated with a currently US authorized COVID-19 vaccine:
- 2 doses of mRNA-1273 (minimum 14 days between doses)
- 2 doses of BNT1262b2 (minimum 14 days between doses)
- Continuous enrollment in medical \& pharmacy plan for at least 365 days prior to index/Cohort entry date (CED)
- Identified as immunocompromised via at least 1 of the following criteria at index/CED
Key exclusion criteria (14 listed)
- Prior COVID-19 infection (any history prior to index/CED through day 13 post-completion of vaccine regimen) identified via the following diagnosis codes on an inpatient or outpatient claim:
- U07.1: "COVID-19, virus identified"
- J12.82: "Pneumonia due to COVID-19"
- Z86.16: "Personal history of COVID-19"
- The following diagnosis codes were utilized early in the pandemic. Exclusion will be applied March 1, 2020 through day 13 post-completion of vaccine regimen:
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 Medically Attended Breakthrough COVID-19 Diagnosis
Time frame: Index date (14-days post-receipt of 2nd dose of mRNA-1273 to BNT162b2) up to end of available data (12 October 2021 [up to 9 months])
Medically attended breakthrough COVID-19 diagnosis defined as a claim for COVID-19 in any setting (inpatient, outpatient, emergency room, urgent care, etc.).
1 secondary outcome
Number of Participants with Breakthrough Hospitalization for COVID-19
Time frame: Index date (14-days post-receipt of 2nd dose of mRNA-1273 to BNT162b2) up to end of available data (12 October 2021 [up to 9 months])
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 9 May 2022.
- Derived from this study: PubMed 36163093Mues KE, Kirk B, Patel DA, Gelman A, Chavers LS, Talarico CA, Esposito DB, Martin D, Mansi J, Chen X, Gatto NM, Van de Velde N. Real-world comparative effectiveness of mRNA-1273 and BNT162b2 vaccines among immunocompromised adults identified in administrative claims data in the United States. Vaccine. 2022 Nov 8;40(47):6730-6739. doi: 10.1016/j.vaccine.2022.09.025. Epub 2022 Sep 24.
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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 11 inclusion and 14 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 9 May 2022. 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 Medically Attended Breakthrough COVID-19 Diagnosis (time frame: Index date (14-days post-receipt of 2nd dose of mRNA-1273 to BNT162b2) up to end of available data (12 October 2021 [up to 9 months])). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05366322, which also lists 1 linked publication.
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 9 May 2022.