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A Clinical Study to Investigate the Safety and Immunogenicity in Relation to Product Attributes of mRNA-1083 (Severe Acute Respiratory Syndrome Coronavirus 2 [SARS-CoV-2] and Influenza Vaccine)
Sponsor: ModernaTX, Inc.
Summary
The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity in relation to the product attributes of mRNA-1083 vaccine when administered as a single intramuscular (IM) injection in adults ≥50 to \<65 years of age.
Official title: A Phase 2, Randomized, Observer-blind Study to Evaluate the Safety, Reactogenicity, and Immunogenicity in Relation to the Product Attributes of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Adults ≥50 to <65 Years of Age
Key Details
Gender
All
Age Range
50 Years - 64 Years
Study Type
INTERVENTIONAL
Enrollment
931
Start Date
2024-07-15
Completion Date
2025-09-25
Last Updated
2026-10-08
Healthy Volunteers
Yes
Conditions
Interventions
mRNA-1083
IM injection in a deltoid muscle.
Locations (17)
Indago Research & Health Center, Inc.
Hialeah, Florida, United States
Cenexel RCA
Hollywood, Florida, United States
Suncoast Research Group, LLC DBA Flourish Research
Miami, Florida, United States
Cenexel IRA
Decatur, Georgia, United States
DM Clinical Research - River Forest
River Forest, Illinois, United States
JCCT
Lenexa, Kansas, United States
Hassman Research Institute - Berlin - CenExel - PPDS
Marlton, New Jersey, United States
DM Clinical Research - Philadelphia
Philadelphia, Pennsylvania, United States
DM Clinical Research - Cyfair Clinical Research Center - PPDS
Houston, Texas, United States
Clinical Trials of Texas, LLC DBA Flourish Research
San Antonio, Texas, United States
DM Clinical Research - Sugarland
Sugar Land, Texas, United States
DM Clinical Research - Tomball MDC
Tomball, Texas, United States
Centricity Research
Toronto, Ontario, Canada
Centricity Research
Toronto, Ontario, Canada
Centricity Research
Pointe-Claire, Quebec, Canada
Diex Recherche Sherbrooke Inc.
Sherbrooke, Quebec, Canada
Diex Recherche Québec Inc.
Québec, Canada