Status:
COMPLETED
A Study to Compare mRNA-1273 Versus BNT162b2 COVID-19 Vaccines Among Immunocompromised Adults
Lead Sponsor:
ModernaTX, Inc.
Conditions:
SARS-CoV-2
Eligibility:
All Genders
18+ years
Brief 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 i...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
- 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"
- 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
Key Trial Info
Start Date :
September 10 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 21 2022
Estimated Enrollment :
124879 Patients enrolled
Trial Details
Trial ID
NCT05366322
Start Date
September 10 2021
End Date
March 21 2022
Last Update
May 9 2022
Active Locations (1)
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1
Aetion Inc.
New York, New York, United States, 10001