NCT05827926

A Study of mRNA-based Influenza and SARS-CoV-2 (COVID-19) Multi-component Vaccines in Healthy Adults

A Phase 1/2, Randomized, Observer-blind, Active-Control Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-based Influenza and SARS-CoV-2 Multi-component Vaccines in Healthy Adults

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 1,758 (actual)
• Sponsor: ModernaTX, Inc. · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

Summary

The study is divided into 2 parts: Part 1 and Part 2. The purpose of Part 1 of this study is to generate sufficient safety, reactogenicity, and immunogenicity data to enable selection of an mRNA-1083 vaccine composition and dose level to evaluate in a subsequent Phase 3 clinical trial in adults. The purpose of Part 2 of this study is to generate safety and immunogenicity data for additional mRNA-1083 compositions and dose levels in young adults ≥18 years and \<50 years of age.

Detailed description

Part 1: Participants will be enrolled into 1 of 2 age cohorts: Cohort A for adults ≥65 to \<80 years of age or Cohort B for adults ≥18 to \<65 year of age. In Cohort A, approximately 600 participants will be randomized (in equal allocation ratio) into the investigational treatment arms, stratified by influenza vaccine status in the most recent influenza season (received or not received since September 2022). In Cohort B, approximately 624 participants will be randomized (in equal allocation ratio) into the investigational treatment arms, stratified by 2 age groups: ≥18 to \<50 years and ≥50 to \<65 years of age and by influenza vaccine status in the most recent influenza season (received or not received since September 2022). Part 2: Approximately, 520 participants between ≥18 to \<50 years of age will be randomized (in equal allocation ratio) into the investigational treatment arms, stratified by influenza vaccine status in the most recent influenza season (received or not received since Sept 2023).

Conditions

• SARS-CoV-2
• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Influenza Vaccine 1	quadrivalent seasonal influenza vaccine
BIOLOGICAL	mRNA-1083.1	Sterile liquid for injection
BIOLOGICAL	mRNA-1083.2	Sterile liquid for injection
BIOLOGICAL	mRNA-1083.3	Sterile liquid for injection
BIOLOGICAL	Investigational Influenza Vaccine 1	Sterile liquid for injection
BIOLOGICAL	Investigational COVID-19 Vaccine 1	Sterile liquid for injection
BIOLOGICAL	COVID-19 Vaccine 1	Sterile liquid for injection
BIOLOGICAL	Investigational Influenza Vaccine 2	Sterile liquid for injection
BIOLOGICAL	Influenza Vaccine 2	quadrivalent seasonal influenza vaccine
BIOLOGICAL	mRNA-1083	Sterile liquid for injection
BIOLOGICAL	Investigational COVID-19 Vaccine 2	Sterile liquid for injection
BIOLOGICAL	COVID-19 Vaccine 2	Sterile liquid for injection

Timeline

• Start date: 2023-04-14
• Primary completion: 2024-12-03
• Completion: 2024-12-03
• First posted: 2023-04-25
• Last updated: 2025-12-23
• Results posted: 2025-12-23

Locations

69 sites across 1 country: United States

Regulatory

• FDA-regulated drug study