NCT06508320

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)

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 932 (actual)
• Sponsor: ModernaTX, Inc. · Industry
• Sex: All
• Age: 50 Years – 64 Years
• Healthy volunteers: Accepted

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.

Detailed description

The study will be comprised of 2 parts, Parts 1 and 2. In Part 1, participants will be randomized into 4 study groups (Lots A, B, C, and D). Upon completion of Part 1, participants will be randomized into 2 study groups (Lots A and E) in Part 2.

Conditions

• Influenza
• SARS-CoV-2

Interventions

Type	Name	Description
BIOLOGICAL	mRNA-1083	IM injection in a deltoid muscle.

Timeline

• Start date: 2024-07-15
• Primary completion: 2025-09-25
• Completion: 2025-09-25
• First posted: 2024-07-18
• Last updated: 2025-10-14

Locations

17 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study