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ACTIVE NOT RECRUITING
NCT05992935
PHASE1/PHASE2

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.

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

mRNA-1403

Sterile liquid for injection

BIOLOGICAL

mRNA-1405

Sterile liquid for injection

BIOLOGICAL

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