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COMPLETED
NCT06508320
PHASE2

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.

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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