A Study of mRNA-1083 (SARS-Cov-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age

Influenza Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06097273
• Other study ID #: mRNA-1083-P301
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: October 19, 2023
• Est. completion date: May 21, 2024

Study information

• Verified date: December 2023
• Source: ModernaTX, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 8075
• Est. completion date: May 21, 2024
• Est. primary completion date: May 21, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Influenza
• Influenza, Human
• SARS-CoV-2

Intervention

Biological:
• mRNA-1083
Suspension for injection
• Placebo
0.9% sodium chloride suspension for injection
• Influenza Vaccine
Commercially available formulation (Suspension for injection [pre-filled syringe])
• COVID-19 Vaccine
Commercially available formulation (Suspension for injection)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
ModernaTX, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geometric Mean (GM) Level of Antibodies for Influenza, as Measured by Hemagglutination Inhibition (HAI) Assay		Day 29
Primary	GM Level of Antibodies for SARS-CoV-2, as Measured by Pseudovirus Neutralization Assay (PsVNA)		Day 29
Primary	Influenza: Percentage of Participants with Seroconversion, as Measured by HAI Assay	Seroconversion is defined as a Day 29 post-injection level =1:40 if baseline is <1:10 or a 4-fold or greater rise if baseline is =1:10 in anti-HA antibodies measured by HAI assay.	Baseline to Day 29
Primary	SARS-CoV-2: Number of Participants with Seroresponse, as Measured by PsVNA	Seroresponse is defined as a Day 29 post-injection level =4-fold if baseline is =lower limit of quantification (LLOQ) or =4*LLOQ if baseline titer is	Baseline to Day 29
Primary	Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)		Up to 7 days after study injection
Primary	Number of Participants With Unsolicited Adverse Events (AEs)		Up to 28 days after study injection
Primary	Number of Participants With Medically Attended Adverse Events (MAAEs)		Day 1 through Day 181
Primary	Number of Participants With Adverse Events of Special Interest (AESIs)		Day 1 through Day 181
Primary	Number of Participants With Serious Adverse Events (SAEs)		Day 1 through Day 181
Primary	Number of Participants With AEs Leading to Discontinuation		Day 1 through Day 181
Secondary	Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza, as Measured by HAI Assay		Day 1, Day 29
Secondary	GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA		Day 1, Day 29