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

Sponsor
ModernaTX, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT05366322
Collaborator
(none)
124,879
Enrollment
1
Location
6.3
Actual Duration (Months)
19796.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Actual Enrollment :
    124879 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Real-world Comparative Effectiveness of the mRNA-1273 Vaccine vs. BNT162b2 Vaccine Among Immunocompromised Adults in the United States
    Actual Study Start Date :
    Sep 10, 2021
    Actual Primary Completion Date :
    Feb 4, 2022
    Actual Study Completion Date :
    Mar 21, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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 Criteria:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aetion Inc. New York New York United States 10001

    Sponsors and Collaborators

    • ModernaTX, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ModernaTX, Inc.
    ClinicalTrials.gov Identifier:
    NCT05366322
    Other Study ID Numbers:
    • mRNA-1273-P913
    First Posted:
    May 9, 2022
    Last Update Posted:
    May 9, 2022
    Last Verified:
    Apr 1, 2022

    Study Results

    No Results Posted as of May 9, 2022