A Study to Compare mRNA-1273 Versus BNT162b2 COVID-19 Vaccines Among Immunocompromised Adults

Completed

Conditions studied: SARS-CoV-2

In brief

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.

Key facts

Study ID

NCT05366322

Run by

ModernaTX, Inc.

People needed

124879

Starts

2021-09-10

Expected to finish

2022-03-21

Last updated by the study team

2022-05-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Aetion Inc. — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.