CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 234 enrolled
Drug / intervention
mRNA-1273biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04860297
NCT04860297Phase 3Completed

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

ModernaTX, Inc.·interventional·Posted Apr 26, 2021·Updated Jun 18, 2024

In Brief

A Phase 3 clinical trial evaluating mRNA-1273 for SARS-CoV-2. Completed, enrolled 234 participants across 15 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSARS-CoV-2
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedApr 26, 2021
Enrollment StartApr 16, 2021
Primary CompletionMay 22, 2023
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 5.2 years ago

Interventions

mRNA-1273biological

Sterile liquid for injection