NCT04956575

A Study of mRNA-1010 Seasonal Influenza Vaccine in Healthy Adults

A Phase 1/2, Randomized, Stratified, Observer-Blind, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 Seasonal Influenza Vaccine in Healthy Adults 18 Years and Older

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 885 (actual)
• Sponsor: ModernaTX, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The study comprises 3 parts: Phase 1/2, Phase 2 Northern Hemisphere (NH), and Phase 2 extension. The primary objective of this study is to evaluate the safety, reactogenicity, and humoral immunogenicity of mRNA-1010 vaccine.

Conditions

• Seasonal Influenza

Interventions

Type	Name	Description
BIOLOGICAL	mRNA-1010	Sterile liquid for injection
BIOLOGICAL	Placebo	0.9% sodium chloride solution for injection
BIOLOGICAL	Active Comparator	0.5 milliliter (mL) intramuscular (IM) injection

Timeline

• Start date: 2021-07-06
• Primary completion: 2022-09-27
• Completion: 2022-09-27
• First posted: 2021-07-09
• Last updated: 2023-10-27
• Results posted: 2023-10-27

Locations

21 sites across 1 country: United States

Regulatory

• FDA-regulated drug study