NCT05606965

A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Adults

Phase 2, Open-Label Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 and Comparator Seasonal Influenza Vaccines in Healthy Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: ModernaTX, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The main purpose of the study is to evaluate the safety, reactogenicity, and the humoral immunogenicity of mRNA-1010 and comparator influenza vaccines against homologous influenza A and B strains at Day 29.

Detailed description

The study consists of 3 parts. Part A of the study was conducted for the 2022-23 influenza season. Part B of the study was conducted in 2023-24 influenza season. Part C of the study will be conducted in 2024-25 influenza season.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	mRNA-1010	Sterile liquid for injection
BIOLOGICAL	Egg-based Quadrivalent Influenza Vaccine	Sterile suspension for injection
BIOLOGICAL	Adjuvanted Quadrivalent Influenza Vaccine	Sterile injectable emulsion
BIOLOGICAL	Inactivated Influenza Vaccine	Sterile suspension for injection
BIOLOGICAL	mRNA-1345	Sterile liquid for injection
BIOLOGICAL	mRNA-1045	Sterile liquid for injection

Timeline

• Start date: 2022-11-02
• Primary completion: 2025-11-13
• Completion: 2025-11-13
• First posted: 2022-11-07
• Last updated: 2025-11-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study