The purpose of the Phase 1 Part of this study is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1403 and mRNA-1405 in healthy adult participants 18 to 49 years of age and 60 to 80 years of age. The purpose of the Phase 2 Part of the study is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1403 in healthy adult participants 18 to 80 years of age.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
1,285
ARK Clinical Research, LLC
Long Beach, California, United States
Tekton Research, Inc - Longmont Center
Longmont, Colorado, United States
Research Centers of America
Hollywood, Florida, United States
Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Time frame: Up to a maximum of Day 36 (7 days after each study injection)
Number of Participants with Unsolicited Adverse Events (AEs)
Time frame: Up to a maximum of Day 57 (28 days after each study injection)
Number of Participants with Medically Attended AEs (MAAEs)
Time frame: Day 1 up to a maximum of Day 197
Number of Participants with Any Serious Adverse Events (SAEs), AEs Leading to Withdrawal From Study/Discontinuation of Study Vaccine, and Adverse Events of Special Interest (AESIs)
Time frame: Day 1 up to a maximum of Day 365
Geometric Mean Titers (GMT) of Histo-blood Group Antigen (HBGA)-blocking Antibodies Against Vaccine-matched Norovirus (NoV) Genotypes
Time frame: Phase 1: Days 1, 29, and 57; Phase 2: Days 1, 29, 365, and 393
Geometric Mean Fold Rise (GMFR) of HBGA-blocking Antibodies Titers
Time frame: Phase 1: Days 1, 29, and 57; Phase 2: Days 1, 29, 365, and 393
Percentage of Participants with Seroresponse Based on HBGA-blocking Antibody Titers
Time frame: Phase 1: Days 29, and 57; Phase 2: Days 29 and 393
Geometric Mean Concentration (GMC) of Binding Antibody (bAb) Against Vaccine-matched NoV Genotypes
Time frame: Days 1, 29, and 57
GMFR of bAb Levels
Time frame: Days 1, 29, and 57
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Accel Research Sites Network
Decatur, Georgia, United States
Velocity Clinical Research - Boise
Meridian, Idaho, United States
Optimal Research
Peoria, Illinois, United States
Velocity Clinical Research
Sioux City, Iowa, United States
Johnson County Clin-Trials (JCCT)
Lenexa, Kansas, United States
Velocity Clinical Research
Rockville, Maryland, United States
Velocity Clinical Research
Norfolk, Nebraska, United States
...and 4 more locations
Percentage of Participants with Seroresponse Based on bAb Levels
Time frame: Days 29 and 57