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Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1403 and mRNA-1405 to Prevent Norovirus Acute Gastroenteritis in Healthy Adults 18 to 80 Years of Age
Sponsor: ModernaTX, Inc.
Summary
The purpose of the Part A Phase 1 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 Part B Phase 2 and Part C Phase 2 is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1403 in healthy adult participants (18 to 80 years of age).
Official title: A Phase 1/2, Randomized, Placebo-Controlled, Observer-Blind, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1403 and mRNA-1405, Multivalent Candidate Vaccines to Prevent Norovirus Acute Gastroenteritis in Healthy Adults 18 to 80 Years of Age
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
1407
Start Date
2023-08-25
Completion Date
2026-09-22
Last Updated
2026-04-03
Healthy Volunteers
Yes
Conditions
Interventions
mRNA-1403
Sterile liquid for injection
mRNA-1405
Sterile liquid for injection
Placebo
0.9% sodium chloride (normal saline) injection
Locations (16)
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
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
Velocity Clinical Research
Omaha, Nebraska, United States
Rochester Clinical Research, Inc
Rochester, New York, United States
Epic Medical Research, LLC
Red Oak, Texas, United States
JBR Clinical Research
Salt Lake City, Utah, United States
Emeritus Research Camberwell
Camberwell, Australia
Nucleus Network
Melbourne, Australia