NCT05375838

A Safety, Reactogenicity, and Immunogenicity Study of mRNA-1073 (COVID-19/Influenza) Vaccine in Adults 18 to 75 Years Old

Phase 1/2, Randomized, Stratified, Observer-blind Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1073 (SARS-CoV-2 and Influenza Vaccine) Compared to Co-administered mRNA-1010 (Influenza) and mRNA-1273 (SARS-CoV-2) Vaccines and to mRNA- 1010 Vaccine and mRNA-1273 Vaccine Alone in Healthy Adults 18-75 Years of Age

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 550 (actual)
• Sponsor: ModernaTX, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The primary goal of this study is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1073 compared to co-administered mRNA-1010 and mRNA-1273 vaccines and to the individual vaccines alone in healthy participants.

Conditions

• SARS-CoV-2
• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	mRNA-1073	Sterile liquid for injection
BIOLOGICAL	mRNA-1010	Sterile liquid for injection
BIOLOGICAL	mRNA-1273	Sterile liquid for injection
BIOLOGICAL	Placebo	0.9% sodium chloride (normal saline) injection

Timeline

• Start date: 2022-05-13
• Primary completion: 2022-12-29
• Completion: 2022-12-29
• First posted: 2022-05-17
• Last updated: 2024-02-28
• Results posted: 2024-02-28

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study