Clinical trial NCT06097273: A Study of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age
Official title: A Phase 3, Randomized, Observer-Blind, Active-Control Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: SARS-CoV-2
Influenza
Keywords: mRNA-1083
mRNA-1083 Vaccine
SARS-CoV-2
SARS-CoV-2 Vaccine
Coronavirus
Virus Diseases
Messenger RNA
Influenza Vaccine
Moderna
Lead sponsor: ModernaTX, Inc.
Sponsor class: INDUSTRY
First posted: 2023-10-24
Enrollment: 8061
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_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, safety, and reactogenicity of mRNA-1083 as compared with active control, co-administered licensed influenza and severe acute respiratory syndrome coronavirus 2 (SARS CoV 2) vaccines, in 2 independent age-group sub-study cohorts, healthy adults 65 years and older (Cohort A) and healthy adults 50 to \<65 years of age (Cohort B).


Eligibility criteria: Key Inclusion Criteria:

* Healthy adults either ≥65 years of age (Cohort A) or 50 to \<65 years of age (Cohort B) at the time of consent (Screening Visit).
* For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1, and agreement to continue adequate contraception through 3 months following vaccine administration.
* Fully vaccinated for COVID-19 primary series according to the locally authorized or approved regimen, and their last COVID-19 vaccine (primary series or booster) was ≥90 days prior to Day 1.

Exclusion Criteria:

* Participant is acutely ill or febrile (temperature ≥38.0 degrees Celsius \[°C\]/100.4 degrees Fahrenheit \[°F\]) 72 hours prior to or at the Screening Visit or Day 1.
* Any medical, psychiatric, or occupational condition, including reported history of drug or alcohol abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.
* Participant has received systemic immunosuppressants for \>14 days in total within 180 days prior to Day 1 (for corticosteroids, ≥10 milligrams \[mg\]/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study. Inhaled nasal and topical steroids are allowed.
* Received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days prior to study injections or plans to receive a vaccine authorized or approved by a local health agency within 28 days after the study injections.
* Received a seasonal influenza vaccine ≤150 days prior to Day 1.
* Tested positive for influenza by local health authority-approved testing methods ≤150 days prior to Day 1.
* Has had close contact to someone with COVID-19 as defined by the Centers for Disease Control and Prevention (CDC) in the past 10 days prior to Day 1.
* Has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Screening Visit or plans to donate blood products during the study.

Note: Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Geometric Mean (GM) Level of Antibodies for Influenza, as Measured by Hemagglutination Inhibition (HAI) Assay
timeFrame: Day 29
measure: GM Level of Antibodies for SARS-CoV-2, as Measured by Pseudovirus Neutralization Assay (PsVNA)
timeFrame: Day 29
measure: Influenza: Percentage of Participants With Seroconversion, as Measured by HAI Assay
timeFrame: Baseline to Day 29
measure: SARS-CoV-2: Percentage of Participants With Seroresponse, as Measured by PsVNA
timeFrame: Baseline to Day 29
measure: Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
timeFrame: Up to 7 days after study injection
measure: Number of Participants With Unsolicited Adverse Events (AEs)
timeFrame: Up to 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
timeFrame: Day 1 through Day 181
Secondary outcomes:
measure: Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza, as Measured by HAI Assay
timeFrame: Day 1, Day 29
measure: GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA
timeFrame: Day 1, Day 29
measure: GM Level of Antibodies for Influenza, as Measured by Microneutralization (MN) Assay
timeFrame: Day 29
measure: GMFR of Antibodies for Influenza, as Measured by MN Assay
timeFrame: Day 1, Day 29
Other outcomes:
measure: Number of Deaths Related to Study Drug mRNA-1083 and Placebo
timeFrame: Day 1 through Day 181
measure: Number of Deaths Related to Control Drug Influenza Vaccine and COVID-19 Vaccine
timeFrame: Day 1 through Day 181
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group-409 E 10th St
state: Alabama
city: Birmingham
country: United States
facility: Accel Research Site - Achieve - Birmingham
state: Alabama
city: Cullman
country: United States
facility: Cullman Clinical Trials
state: Alabama
city: Mesa
country: United States
facility: Desert Clinical Research - CCT - PPDS
state: Arizona
city: Phoenix
country: United States
facility: Foothills Research Center - CCT - PPDS
state: Arizona
city: Scottsdale
country: United States
facility: Headlands Research - Scottsdale - PPDS
state: Arizona
city: Scottsdale
country: United States
facility: Scottsdale Clinical Trials
state: Arizona
city: Tempe
country: United States
facility: Fiel Family & Sports Medicine - PC - CCT - PPDS
state: Arizona
city: Cerritos
country: United States
facility: AES - DRS - Synexus Clinical Research US, Inc. - Cerritos
state: California
city: Long Beach
country: United States
facility: Long Beach Research Institute, LLC
state: California
city: Los Alamitos
country: United States
facility: CenExel Apex (CNS) - Los Alamitos - PPDS
state: California
city: Modesto
country: United States
facility: Central Valley Research, LLC
state: California
city: North Hollywood
country: United States
facility: Carbon Health- NoHo West Urgent Care and Primary Care
state: California
city: Pomona
country: United States
facility: Empire Clinical Research
state: California
city: Riverside
country: United States
facility: Artemis Institute For Clinical Research LLC - Riverside - Headlands - PPDS
state: California
city: Riverside
country: United States
facility: Clinical Innovations Trials - Riverside - CenExel - PPDS
state: California
city: Rolling Hills Estates
country: United States
facility: Peninsula Research Associates - Headlands - PPDS
state: California
city: San Diego
country: United States
facility: Artemis Institute For Clinical Research LLC - San Diego - Headlands - PPDS
state: California
city: Vista
country: United States
facility: AES - DRS - Synexus Clinical Research US, Inc. - Vista
state: California
city: Fort Collins
country: United States
facility: Tekton Research - Fort Collins - PPDS
state: Colorado
city: Longmont
country: United States
facility: Tekton Research - Longmont - PPDS
state: Colorado
city: Stamford
country: United States
facility: Stamford Therapeutics Consortium - ERN - PPDS
state: Connecticut
city: Waterbury
country: United States
facility: Chase Medical Research LLC - Waterbury
state: Connecticut
city: Doral
country: United States
facility: Revival Research Corporation
state: Florida
city: Hialeah
country: United States
facility: Indago Research and Health Center
state: Florida
city: Hollywood
country: United States
facility: CenExel RCA - Hollywood
state: Florida
city: Inverness
country: United States
facility: Nature Coast Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center For Clinical Research
state: Florida
city: Jupiter
country: United States
facility: Health Awareness - Jupiter - ERN - ERN
state: Florida
city: Largo
country: United States
facility: Accel Research Sites - Saint Petersburg - Largo - ERN - PPDS
state: Florida
city: Leesburg
country: United States
facility: Flourish Research - Leesburg - PPDS
state: Florida
city: Maitland
country: United States
facility: Accel Research Sites - Maitland
state: Florida
city: Melbourne
country: United States
facility: AES - DRS - Optimal Research Florida - Melbourne
state: Florida
city: Miami
country: United States
facility: Suncoast Research Group LLC - Flourish - PPDS
state: Florida
city: Saint Augustine
country: United States
facility: St. Johns Center for Clinical Research - ERN - PPDS
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research - CenExel FCR - PPDS
state: Florida
city: Atlanta
country: United States
facility: AES - DRS - Synexus Clinical Research US, Inc. - Atlanta
state: Georgia
city: Atlanta
country: United States
facility: DelRicht Research, LLC - Springer Wellness & Restorative - Atlanta - PPDS
state: Georgia
city: Decatur
country: United States
facility: iResearch Atlanta - CenExel - PPDS
state: Georgia
city: Fayetteville
country: United States
facility: Javara, Inc./Privia Medical Group Georgia, LLC - Fayetteville - Javara - PPDS
state: Georgia
city: Norcross
country: United States
facility: Georgia Clinic - CCT - PPDS
state: Georgia
city: Savannah
country: United States
facility: Privia Medical Group Georgia, LLC - Savannah - Javara - PPDS
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research Atlanta - ERN - PPDS
state: Georgia
city: Chicago
country: United States
facility: AES - DRS - Synexus Clinical Research US, Inc. - Chicago
state: Illinois
city: Chicago
country: United States
facility: Cedar Crosse Research Center
state: Illinois
city: Chicago
country: United States
facility: Flourish Research - Andersonville - PPDS
state: Illinois
city: Morton
country: United States
facility: Koch Family Medicine
state: Illinois
city: Peoria
country: United States
facility: AES - DRS - Optimal Research Illinois - Peoria
state: Illinois
city: River Forest
country: United States
facility: DM Clinical Research - Chicago - ERN - PPDS
state: Illinois
city: Evansville
country: United States
facility: AES - DRS - Synexus Clinical Research US, Inc. - Evansville
state: Indiana
city: Valparaiso
country: United States
facility: Velocity Clinical Research - Valparaiso (Buynak Clinical Research) - PPDS
state: Indiana
city: West Des Moines
country: United States
facility: The Iowa Clinic, P.C. - West Des Moines Campus
state: Iowa
city: Lenexa
country: United States
facility: Johnson County Clin-Trials
state: Kansas
city: Overland Park
country: United States
facility: Delricht Overland Park
state: Kansas
city: Wichita
country: United States
facility: Tekton Research - Wichita - PPDS
state: Kansas
city: Louisville
country: United States
facility: DelRicht Research, LLC - Louisville - PPDS
state: Kentucky
city: Versailles
country: United States
facility: Versailles Family Medicine - CCT - PPDS
state: Kentucky
city: Baton Rouge
country: United States
facility: Velocity Clinical Research (Baton Rouge - Louisiana) - PPDS
state: Louisiana
city: Covington
country: United States
facility: Velocity Clinical Research - Covington - PPDS
state: Louisiana
city: Mandeville
country: United States
facility: DelRicht Clinical Research, LLC - The Murphy Clinic - PPDS
state: Louisiana
city: Monroe
country: United States
facility: IMA Clinical Research - Monroe, LA - PPDS
state: Louisiana
city: New Orleans
country: United States
facility: DelRicht Clinical Research, LLC - New Orleans - ClinEdge - PPDS
state: Louisiana
city: Prairieville
country: United States
facility: DelRicht Research, LLC - Internal - Baton Rouge - PPDS
state: Louisiana
city: Annapolis
country: United States
facility: Annapolis Internal Medicine - CCT - PPDS
state: Maryland
city: Rockville
country: United States
facility: Advanced Primary Care & Geriatric Care - CCT - PPDS
state: Maryland
city: Rockville
country: United States
facility: DelRicht Clinical Research, LLC - Matthew Mintz, MD - PPDS
state: Maryland
city: Rockville
country: United States
facility: Velocity Clinical Research (Rockville - Maryland) - PPDS
state: Maryland
city: Silver Spring
country: United States
facility: Privia Medical Group, LLC - Columbia Pike - Silver Spring - Javara - PPDS
state: Maryland
city: Brookline
country: United States
facility: DM Clinical Research - The Brook House - ERN - PPDS
state: Massachusetts
city: Southfield
country: United States
facility: Headlands Research - Detroit - Headlands - PPDS
state: Michigan
city: Southfield
country: United States
facility: Great Lakes Research Institute
state: Michigan
city: Southfield
country: United States
facility: DM Clinical Research - Southfield - ERN - PPDS
state: Michigan
city: Mankato
country: United States
facility: Mankato Clinic - Premier Drive - Javara - PPDS
state: Minnesota
city: Richfield
country: United States
facility: AES - DRS - Synexus Clinical Research US, Inc. - Minneapolis
state: Minnesota
city: Gulfport
country: United States
facility: DelRicht Research, LLC - Gulfport - PPDS
state: Mississippi
city: Creve Coeur
country: United States
facility: AES - DRS - Synexus Clinical Research US, Inc. - St. Louis
state: Missouri
city: Kansas City
country: United States
facility: Clay Platte Family Medicine - CCT Research
state: Missouri
city: Saint Louis
country: United States
facility: Sundance Clinical Research - ERN - PPDS
state: Missouri
city: Springfield
country: United States
facility: Clinvest - National Ave - Headlands - PPDS
state: Missouri
city: Springfield
country: United States
facility: DelRicht Research, LLC - Command Family Medicine - Springfield - DelRicht - PPDS
state: Missouri
city: Town And Country
country: United States
facility: DelRicht Clinical Research, LLC - MS. Medicine - PPDS
state: Missouri
city: Elkhorn
country: United States
facility: Skyline Medical Center - PC - CCT - PPDS
state: Nebraska
city: Fremont
country: United States
facility: Methodist Physicians Clinic - CCT Research - PPDS
state: Nebraska
city: Lincoln
country: United States
facility: Velocity Clinical Research (Lincoln - Nebraska) - PPDS
state: Nebraska
city: Omaha
country: United States
facility: Velocity Clinical Research
state: Nebraska
city: Omaha
country: United States
facility: Midwest Regional Health Services - LLC - CCT - PPDS
state: Nebraska
city: Papillion
country: United States
facility: Papillion Research Center
state: Nebraska
city: Henderson
country: United States
facility: AES - DRS - Synexus Clinical Research US, Inc. - Henderson
state: Nevada
city: Las Vegas
country: United States
facility: Santa Rosa Urgent Care - Primary Care - CCT - PPDS
state: Nevada
city: North Las Vegas
country: United States
facility: Las Vegas Clinical Trials
state: Nevada
city: Berlin
country: United States
facility: Hassman Research Institute - HRI - Berlin - CenExel - PPDS
state: New Jersey
city: Albuquerque
country: United States
facility: Velocity Clinical Research - Albuquerque - PPDS
state: New Mexico
city: Santa Fe
country: United States
facility: AXCES Research Group - Sante Fe - ERN - PPDS
state: New Mexico
city: Brooklyn
country: United States
facility: DM Clinical Research - Brooklyn
state: New York
city: New York
country: United States
facility: AES - DRS - Synexus Clinical Research US, Inc. - New York
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc
state: New York
city: Charlotte
country: United States
facility: DelRicht Research, LLC - Charlotte - PPDS
state: North Carolina
city: Charlotte
country: United States
facility: Tryon Medical Partners, PLLC and Javara Inc. - Javara - PPDS
state: North Carolina
city: Monroe
country: United States
facility: Monroe Biomedical Research -343 Venus St
state: North Carolina
city: Wilmington
country: United States
facility: Trial Management Associates LLC - ERN - PPDS
state: North Carolina
city: Cincinnati
country: United States
facility: CTI Clinical Research Center - PPDS
state: Ohio
city: Cincinnati
country: United States
facility: Velocity Clinical Research (Cincinnati - Ohio) - PPDS
state: Ohio
city: Cincinnati
country: United States
facility: AES - DRS - Synexus Clinical Research US, Inc. - Cincinnati
state: Ohio
city: Cincinnati
country: United States
facility: Velocity Clinical Research (Cincinnati - Ohio) - PPDS
state: Ohio
city: Columbus
country: United States
facility: AES - DRS - Synexus Clinical Research US, Inc. - Columbus
state: Ohio
city: Huber Heights
country: United States
facility: WellNow Urgent Care & Research - Huber Heights
state: Ohio
city: Edmond
country: United States
facility: Tekton Research - Edmond - PPDS
state: Oklahoma
city: Oklahoma City
country: United States
facility: Lynn Institute of East Oklahoma - ERN - PPDS
state: Oklahoma
city: Tulsa
country: United States
facility: DelRicht Research, LLC - Internal - Tulsa - PPDS
state: Oklahoma
city: Yukon
country: United States
facility: Tekton Research - Yukon - PPDS
state: Oklahoma
city: Corvallis
country: United States
facility: The Corvallis Clinic, PC - 3680 NW Samaritan Drive
state: Oregon
city: Hatboro
country: United States
facility: Hatboro Medical Associates - CCT - PPDS
state: Pennsylvania
city: Philadelphia
country: United States
facility: DM Clinical Research - Philadelphia - ERN - PPDS
state: Pennsylvania
city: Anderson
country: United States
facility: AES - DRS - Synexus Clinical Research US, Inc. - Anderson
state: South Carolina
city: Myrtle Beach
country: United States
facility: TMA - Myrtle Beach - ERN - PPDS
state: South Carolina
city: Spartanburg
country: United States
facility: Velocity Clinical Research - Spartanburg - PPDS
state: South Carolina
city: Hendersonville
country: United States
facility: DelRicht Research, LLC - Hendersonville - PPDS
state: Tennessee
city: Austin
country: United States
facility: AES - DRS - Optimal Research Texas - Austin
state: Texas
city: Austin
country: United States
facility: Benchmark Research - Austin - HyperCore - PPDS
state: Texas
city: Austin
country: United States
facility: Tekton Research - Austin - PPDS
state: Texas
city: Beaumont
country: United States
facility: Tekton Research Inc
state: Texas
city: Brownsville
country: United States
facility: Headlands Research - Brownsville - Headlands - PPDS
state: Texas
city: Dallas
country: United States
facility: AES - DRS - Synexus Clinical Research US, Inc. - Dallas
state: Texas
city: El Paso
country: United States
facility: 3A Research, LLC
state: Texas
city: Fort Worth
country: United States
facility: Privia Medical Group- North Texas - West Parker Road - Fort Worth - Javara - PPDS
state: Texas
city: Friendswood
country: United States
facility: Mount Olympus Medical Research Group - ClinEdge - PPDS
state: Texas
city: Houston
country: United States
facility: DM Clinical Research - Cyfair Clinical Research Center - ERN - PPDS
state: Texas
city: Houston
country: United States
facility: DM Clinical Research - Bellaire - ERN - PPDS
state: Texas
city: Humble
country: United States
facility: DM Clinical Research - Texas Center for Drug Development - Humble - ERN - PPDS
state: Texas
city: McKinney
country: United States
facility: DelRicht Research, LLC - Zomnir Family Medicine - DelRicht - PPDS
state: Texas
city: San Angelo
country: United States
facility: Benchmark Research - San Angelo - HyperCore - PPDS
state: Texas
city: San Antonio
country: United States
facility: Sun Research Institute -427 9th St
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc. - PPDS
state: Texas
city: San Antonio
country: United States
facility: IMA Clinical Research - San Antonio - PPDS
state: Texas
city: San Antonio
country: United States
facility: Tekton Research - San Antonio - PPDS
state: Texas
city: San Marcos
country: United States
facility: Privia Medical Group Gulf Coast, PLLC - San Marcos - Javara - PPDS
state: Texas
city: Stephenville
country: United States
facility: Privia Medical Group- North Texas - Stephenville - Javara - PPDS
state: Texas
city: Sugar Land
country: United States
facility: DM Clinical Research - Sugarland - ERN - PPDS
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research - ERN - PPDS
state: Texas
city: Bountiful
country: United States
facility: Cope Family Medicine - CCT - PPDS
state: Utah
city: Pleasant View
country: United States
facility: Ogden Clinic - Mountain View - CCT - PPDS
state: Utah
city: Roy
country: United States
facility: Ogden Clinic - Grandview - CCT - PPDS
state: Utah
city: S. Salt Lake
country: United States
facility: AES - DRS - Synexus Clinical Research US, Inc. - Salt Lake City
state: Utah
city: Salt Lake City
country: United States
facility: JBR Clinical Research - CenExel JBR - PPDS
state: Utah
city: Portsmouth
country: United States
facility: Velocity Clinical Research - Family Practice - Portsmouth - PPDS
state: Virginia
city: Wenatchee
country: United States
facility: Wenatchee Valley Hospital & Clinics Campus
state: Washington
Study officials:
References: