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

NCT05366322 | Completed

• 1 other identifier: mRNA-1273-P913
• Study Type: observational
• Target: 124,879
• Locations: 1 country
• Sites: 1

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.

Conditions

SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• 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.).

  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

  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])

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Fully vaccinated with a currently US authorized COVID-19 vaccine:
• doses of mRNA-1273 (minimum 14 days between doses)
• 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"
• 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

Sponsors & Collaborators

• ModernaTX, Inc.: lead

Study Sites (1)

Aetion Inc.

New York, New York, 10001, United States

Location

Related Publications (1)

• 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.

  PMID: 36163093 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: May 9, 2022
• Study Start: September 10, 2021
• Primary Completion: February 4, 2022
• Study Completion: March 21, 2022
• Last Updated: May 9, 2022

Record last verified: 2022-04

Locations

US (1)