NCT05585632

A Safety, Reactogenicity, and Immunogenicity Study of mRNA-1045 (Influenza and Respiratory Syncytial Virus [RSV]) or mRNA-1230 (Influenza, RSV, and Severe Acute Respiratory Syndrome Coronavirus 2 [SARS-CoV-2]) Vaccine in Adults 50 to 75 Years Old

Phase 1, Randomized, Observer-blind Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Multi-component Vaccines mRNA-1045 (Influenza and RSV) or mRNA-1230 (Influenza, RSV, and SARS-CoV-2) Compared With mRNA-1010 (Influenza), mRNA-1345 (RSV), and mRNA-1273.214 (SARS-CoV-2) Vaccines in Healthy Adults 50-75 Years of Age

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 392 (actual)
• Sponsor: ModernaTX, Inc. · Industry
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The primary goal of this study is to evaluate the safety and reactogenicity of multi-component vaccines mRNA-1045 (Influenza and RSV) and mRNA-1230 (influenza, RSV, and SARS-CoV-2) compared with mRNA-1010 (influenza), mRNA-1345 (RSV), and mRNA-1273.214 (SARS-CoV-2) vaccines in healthy older participants.

Conditions

• SARS-CoV-2
• Influenza
• RSV

Interventions

Type	Name	Description
BIOLOGICAL	mRNA-1010	Sterile liquid for injection
BIOLOGICAL	mRNA-1345	Sterile liquid for injection
BIOLOGICAL	mRNA-1273.214	Sterile liquid for injection
BIOLOGICAL	mRNA-1045	Formulation for injection
BIOLOGICAL	mRNA-1230	Formulation for injection

Timeline

• Start date: 2022-10-14
• Primary completion: 2024-02-28
• Completion: 2024-02-28
• First posted: 2022-10-19
• Last updated: 2024-03-08

Locations

30 sites across 3 countries: United States, Australia, United Kingdom

Regulatory

• FDA-regulated drug study