NCT04860297

A Study to Evaluate Safety and Immunogenicity of mRNA-1273 Vaccine to Prevent COVID-19 in Adult Organ Transplant Recipients and in Healthy Adult Participants

A Phase 3b, Open-Label, Safety and Immunogenicity Study of SARS-CoV-2 mRNA-1273 Vaccine in Adult Solid Organ Transplant Recipients and Healthy Controls

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 234 (actual)
• Sponsor: ModernaTX, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is an open-label study to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1273 Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) vaccine in adults with a kidney or liver solid organ transplant (SOT) and in healthy adult participants. The primary goal of the study is to evaluate the safety of mRNA-1273 and the serum antibody (Ab) responses obtained 28 days after the last dose of mRNA-1273.

Conditions

• SARS-CoV-2

Interventions

Type	Name	Description
BIOLOGICAL	mRNA-1273	Sterile liquid for injection

Timeline

• Start date: 2021-04-16
• Primary completion: 2023-05-22
• Completion: 2023-05-22
• First posted: 2021-04-26
• Last updated: 2024-06-18
• Results posted: 2024-06-18

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study