A Study to Compare mRNA-1273 Versus BNT162b2 COVID-19 Vaccines Among Immunocompromised Adults
- Conditions
- SARS-CoV-2
- Registration Number
- NCT05366322
- Lead Sponsor
- ModernaTX, Inc.
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 124879
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants with Medically Attended Breakthrough COVID-19 Diagnosis 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.).
- Secondary Outcome Measures
Name Time Method Number of Participants with Breakthrough Hospitalization for COVID-19 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]) 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.
Trial Locations
- Locations (1)
Aetion Inc.
🇺🇸New York, New York, United States
Aetion Inc.🇺🇸New York, New York, United States