Clinical trial NCT06864143: A Study to Investigate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 (Influenza and COVID-19) Vaccine in Adults ≥18 to <65 Years of Age
Official title: A Phase 2, Randomized, Observer-blind, Active-control Study to Evaluate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 (Influenza and COVID-19) Vaccine in Adults ≥18 to <65 Years of Age
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Influenza
SARS-CoV-2
Keywords: Influenza
SARS-CoV-2
mRNA-1083
COVID-19
Messenger RNA
Moderna
Lead sponsor: ModernaTX, Inc.
Sponsor class: INDUSTRY
First posted: 2025-03-07
Enrollment: 1300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the immunogenicity, reactogenicity, and safety, of mRNA-1083 multicomponent influenza and COVID-19 vaccine in adults ≥18 to \<65 years of age.


Eligibility criteria: Inclusion Criteria:

* Medically stable.
* Participants who could become pregnant: negative pregnancy test and contraception for at least 28 days prior to Day 1 and for at least 90 days after the study intervention administration.
* Have received ≥2 coronavirus disease 2019 (COVID-19) vaccines, with the last COVID-19 vaccine administered \>150 days prior to Day 1.

Exclusion Criteria:

* History of a diagnosis or condition that is clinically unstable or may affect participant safety, assessment of study endpoints, assessment of immune response, or adherence to study procedures.
* Tested positive for influenza by local health authority-approved testing methods within 150 days prior to Day 1.
* History of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 150 days prior to Day 1.
* Received systemic immunosuppressive treatment, including long-acting biological therapies that affect immune responses (eg, infliximab), within 180 days prior to Day 1 or plans to do so during the study.
* Received or plans to receive any vaccine authorized or approved by a local health agency within 28 days prior to Day 1 or plans to do so within 28 days post study injection.
* Received a licensed seasonal influenza vaccine within 150 days prior to Day 1.
* Received a licensed/authorized COVID-19 vaccine within 150 days prior to Day 1.
* Received any investigational influenza vaccine, investigational COVID-19 vaccine, or investigational combination vaccine for influenza and COVID-19 within 12 months prior to Day 1.
* Participated in a clinical study with investigational treatment within 90 days prior to Day 1 (Baseline).

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Geometric Mean Titer (GMT) as Measured by Hemagglutination Inhibition (HAI) Assay for Influenza
timeFrame: Day 29
measure: Geometric Mean Concentration (GMC) as Measured by Pseudovirus Neutralization Assay (PsVNA) for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
timeFrame: Day 29
measure: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
timeFrame: Day 1 through 7 days after study injection
measure: Number of Participants With Unsolicited Adverse Events (AEs)
timeFrame: Day 1 through 28 days after study injection
measure: Number of Participants With Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation From the Study
timeFrame: Day 1 through Day 181
Secondary outcomes:
measure: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza as Measured by HAI Assay
timeFrame: Baseline (Day 1), Day 29
measure: GMFR of Antibodies for SARS-CoV-2 as Measured by PsVNA
timeFrame: Baseline (Day 1), Day 29
measure: Influenza: Percentage of Participants with Seroconversion as Measured by HAI Assay
timeFrame: Baseline (Day 1) to Day 29
measure: SARS-CoV-2: Percentage of Participants with Seroresponse as Measured by PsVNA
timeFrame: Baseline (Day 1) to Day 29
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Headlands Research Scottsdale
state: Arizona
city: San Diego
country: United States
facility: Artemis Research (Headlands)
state: California
city: Stockbridge
country: United States
facility: Clinical Research Atlanta (Headlands)
state: Georgia
city: Meridian
country: United States
facility: Velocity Clinical Research, Boise
state: Idaho
city: Melrose Park
country: United States
facility: DM Clinical Research - Chicago
state: Illinois
city: Lafayette
country: United States
facility: Velocity Clinical Research, Lafayette
state: Louisiana
city: Rockville
country: United States
facility: Velocity Clinical Research, Rockville
state: Maryland
city: Brookline
country: United States
facility: DM Clinical Research - Boston
state: Massachusetts
city: Southfield
country: United States
facility: DM Clinical Research - Detroit
state: Michigan
city: Norfolk
country: United States
facility: Velocity Clinical Research, Norfolk
state: Nebraska
city: Wilmington
country: United States
facility: Trial Management Associates, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: Velocity Clinical Research, Cincinnati, Mt. Auburn
state: Ohio
city: Cincinnati
country: United States
facility: Velocity Clinical Research, Cincinnati, Springdale
state: Ohio
city: Philadelphia
country: United States
facility: DM Clinical Research - Philadelphia
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: Trial Management Associates, LLC
state: South Carolina
city: Houston
country: United States
facility: DM Clinical Research - Bellaire
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research - Tomball
state: Texas
Study officials:
References: