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.
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Parts A and B: Number of SOT Participants With Unsolicited Adverse Events (AEs)
Timeframe: Up to 28 days post-vaccination
Parts A and B: Number of Healthy Participants With Unsolicited AEs
Timeframe: Up to 28 days post-vaccination
Parts A and B: Number of SOT Participants With Medically-Attended Adverse Events (MAAEs)
Timeframe: Throughout the study period (up to Day 450)
Parts A and B: Number of Healthy Participants With MAAEs
Timeframe: Throughout the study period (up to Day 394)
Parts A and B: Number of SOT Participants With Serious Adverse Events (SAEs)
Timeframe: Throughout the study period (up to Day 450)
Parts A and B: Number of Healthy Participants With SAEs
Timeframe: Throughout the study period (up to Day 394)
Parts A and B: Number of SOT Participants With Adverse Event of Special Interests (AESIs), Including Myocarditis/Pericarditis
Timeframe: Throughout the study period (up to Day 450)
Parts A and B: Number of Healthy Participants With AESIs, Including Myocarditis/Pericarditis
Timeframe: Throughout the study period (up to Day 394)
Parts A and B: Number of SOT Participants With AEs Leading to Discontinuation From Dosing and/or Study Participation (Withdrawal)
Timeframe: Throughout the study period (up to Day 450)
Parts A and B: Number of Healthy Participants With AEs Leading to Discontinuation From Dosing and/or Study Participation (Withdrawal)
Timeframe: Throughout the study period (up to Day 394)
Parts A and B: Number of SOT Participants With Adjudicated Biopsy-Proven Organ Rejection
Timeframe: Throughout the study period (up to Day 450)
Parts A and B: Number of Healthy Participants With Biopsy-Proven Organ Rejection
Timeframe: Throughout the study period (up to Day 394)
Parts A and B: Number of SOT Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Timeframe: 7 days post-vaccination
Parts A and B: Number of Healthy Participants With Solicited Local and Systemic ARs
Timeframe: 7 days post-vaccination
Part A: Geometric Mean Concentration (GMC) of Serum SARS-CoV-2-Specific Neutralizing Antibody (nAb) After the Second Dose in Unvaccinated Participants
Timeframe: Day 57 (for unvaccinated participants)
Part A: GMC of SARS-CoV-2-Specific nAb 28 Days After Dose 3
Timeframe: 28 days after Dose 3
Part B: GMC of SARS-CoV-2-Specific nAb 28 Days After the BD in SOT Participants Who Received the Moderna Primary Series and Non-Moderna Primary Series
Timeframe: 28 days after BD injection (BD-Day 29)