The primary goal for this study is to evaluate the safety and reactogenicity of 3 dose levels of mRNA-1283 and 1 dose level of mRNA-1273 vaccine given to healthy adults in 2 doses, 28 days apart, and 1 dose level of mRNA-1283 administered as a single dose to healthy adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
104
Synexus Clinical Research US Phoenix Southeast, Inc.
Chandler, Arizona, United States
Optimal Research San Diego, LLC
San Diego, California, United States
Optimal Research Melbourne, LLC
Melbourne, Florida, United States
Optimal Research Illinois, LLC
Peoria, Illinois, United States
Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Time frame: Up to Day 36 (7 days after second dose)
Number of Participants with Unsolicited Adverse Events (AEs)
Time frame: Up to Day 57 (28 days after second dose)
Number of Participants with Medically-Attended AEs (MAAEs), AE of Special Interest (AESIs), and Serious Adverse Events (SAEs)
Time frame: Up to Day 394 (1 year after second dose)
Geometric Mean (GM) of SARS-CoV-2 Specific Neutralizing Antibody (nAb)
Time frame: Day 1, Day 29, Day 36, Day 57, Day 209, and Day 394
GM of SARS-CoV-2-Specific Binding Antibody (bAb)
Time frame: Day 1, Day 29, Day 36, Day 57, Day 209, and Day 394
Seroconversion as Measured by an Increase of SARS-CoV-2-Specific nAb Titer or bAb Titer
Seroconversion measured as defined for the study.
Time frame: Day 1, Day 29, Day 36, Day 57, Day 209, and Day 394
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Optimal Research Texas, LLC
Austin, Texas, United States