NCT05827068

A Study of mRNA-1011.1, mRNA-1011.2, and mRNA-1012.1 Candidate Seasonal Influenza Vaccines in Healthy Adults

A Phase 1/2, Randomized, Open-Label Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1011.1, mRNA-1011.2, and mRNA-1012.1 Candidate Seasonal Influenza Vaccines in Healthy Adults 50 to 75 Years of Age

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 698 (actual)
• Sponsor: ModernaTX, Inc. · Industry
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to measure the safety and the immune response to 3 next-generation influenza vaccine candidates (mRNA-1011.1, mRNA-1011.2, and mRNA-1012.1) compared with influenza vaccine candidate mRNA-1010 controls in healthy adult participants.

Conditions

• Seasonal Influenza

Interventions

Type	Name	Description
BIOLOGICAL	mRNA-1011.1	Sterile liquid for injection
BIOLOGICAL	mRNA-1011.2	Sterile liquid for injection
BIOLOGICAL	mRNA-1012.1	Sterile liquid for injection
BIOLOGICAL	mRNA-1010	Sterile liquid for injection
BIOLOGICAL	mRNA-1010.2	Sterile liquid for injection
BIOLOGICAL	mRNA-1010.3	Sterile liquid for injection

Timeline

• Start date: 2023-03-27
• Primary completion: 2023-11-20
• Completion: 2023-11-20
• First posted: 2023-04-24
• Last updated: 2025-02-03
• Results posted: 2025-02-03

Locations

22 sites across 1 country: United States

Regulatory

• FDA-regulated drug study