A Clinical Study to Investigate the Safety and Immunogenicity in Relation to Product Attributes of mRNA-1083 (Severe Acute Respiratory Syndrome Coronavirus 2 [SARS-CoV-2] and Influenza Vaccine)

NCT06508320 | Completed Phase 2 FDA Drug

• 1 other identifier: mRNA-1083-P201
• Study Type: interventional
• Target: 932
• Locations: 2 countries
• Sites: 17

Brief Summary

The purpose of this study is to evaluate the safety, reactogenicity, and immunogenicity in relation to the product attributes of mRNA-1083 vaccine when administered as a single intramuscular (IM) injection in adults ≥50 to \<65 years of age.

Conditions

Influenza; SARS-CoV-2

Keywords

Influenza; SARS-CoV-2; mRNA-1083

Outcome Measures

Primary Outcomes (8)

• Geometric Mean Value of Antibodies at Day 29, as Measured by Hemagglutinin Inhibition (HAI) Assay for Influenza

  Day 29

• Geometric Mean Value of Antibodies at Day 29, as Measured by Pseudovirus Neutralization Assay (PsVNA) for SARS-CoV-2

  Day 29

• Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)

  Up to Day 7 (7 days after vaccination)

• Number of Participants with Unsolicited Adverse Events (AEs)

  Up to Day 28 (28 days after vaccination)

• Number of Participants with Medically Attended Adverse Events (MAAEs)

  Up to Day 181

• Number of Participants with Adverse Events of Special Interest (AESIs)

  Up to Day 181

• Number of Participants with Serious Adverse Events (SAEs)

  Up to Day 181

• Number of Participants with AEs Leading to Discontinuation from Study Participation

  Up to Day 181

Secondary Outcomes (4)

• Geometric Mean Fold Rise (GMFR) of Antibodies at Day 29 Relative to Day 1, as Measured by HAI Assay for Influenza

  Day 1, Day 29

• GMFR of Antibodies at Day 29 Relative to Day 1, as Measured by PsVNA for SARS-CoV-2

  Day 1, Day 29

• Seroconversion Rate (SCR) in Anti-hemagglutinin (HA) Antibody Values at Day 29, as Measured by HAI Assay for Influenza

  Day 29

• Seroresponse Rate (SRR) in Neutralizing Antibody (nAb) Values at Day 29, as Measured by PsVNA for SARS-CoV-2

  Day 29

Study Arms (6)

Part 1 Group 1: mRNA-1083 Lot A

EXPERIMENTAL

Participants will receive mRNA-1083 Lot A as a single injection on Day 1 in Part 1.

Biological: mRNA-1083

Part 1 Group 2: mRNA-1083 Lot B

EXPERIMENTAL

Participants will receive mRNA-1083 Lot B as a single injection on Day 1 in Part 1.

Biological: mRNA-1083

Part 1 Group 3: mRNA-1083 Lot C

EXPERIMENTAL

Participants will receive mRNA-1083 Lot C as a single injection on Day 1 in Part 1.

Biological: mRNA-1083

Part 1 Group 4: mRNA-1083 Lot D

EXPERIMENTAL

Participants will receive mRNA-1083 Lot D as a single injection on Day 1 in Part 1.

Biological: mRNA-1083

Part 2 Group 5: mRNA-1083 Lot A

EXPERIMENTAL

Participants will receive mRNA-1083 Lot A as a single injection on Day 1 in Part 2.

Biological: mRNA-1083

Part 2 Group 6: mRNA-1083 Lot E

EXPERIMENTAL

Participants will receive mRNA-1083 Lot E as a single injection on Day 1 in Part 2.

Biological: mRNA-1083

Interventions

mRNA-1083 BIOLOGICAL

IM injection in a deltoid muscle.

Part 1 Group 1: mRNA-1083 Lot A; Part 1 Group 2: mRNA-1083 Lot B; Part 1 Group 3: mRNA-1083 Lot C; Part 1 Group 4: mRNA-1083 Lot D; Part 2 Group 5: mRNA-1083 Lot A; Part 2 Group 6: mRNA-1083 Lot E

Eligibility Criteria

• Age: 50 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Investigator assessment that the participant understands and is willing and physically able to comply with protocol-mandated follow-up, including all procedures.
• Participants of nonchildbearing potential may be enrolled in the study.
• Participants who could become pregnant: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy.
• Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
• Have received an influenza vaccine in the previous season (since September 2023 for Part 1, since Sep 2024 for Part 2).

You may not qualify if:

• Reported diagnosis or condition that is associated with increased risk of severe influenza disease or complications, including individuals with chronic medical conditions.
• Reported history of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infections.
• History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any of the following: mRNA vaccine or therapeutic; components of an mRNA vaccine or therapeutic; influenza vaccine; or components of an influenza vaccine, including egg protein.
• Received corticosteroids at ≥10 milligrams (mg)/day of prednisone or equivalent for \>14 days in total within 90 days prior to Day 1 or is anticipating the need for corticosteroids at any time during the study.
• Received systemic immunosuppressive treatment, including long-acting biological therapies that affect immune responses (e.g., 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 SARS-CoV-2 vaccine within 90 days prior to Day 1.
• Received any investigational influenza vaccine, investigational coronavirus disease 2019 (COVID-19) vaccine, or investigational combination vaccine for influenza and COVID-19 within 12 months prior to Day 1. Participants from mRNA-1083-P201 Part 1 will also be excluded from Part 2.

Sponsors & Collaborators

• ModernaTX, Inc.: lead

Study Sites (17)

Indago Research & Health Center, Inc.

Hialeah, Florida, 33012, United States

Location

Cenexel RCA

Hollywood, Florida, 33024, United States

Location

Suncoast Research Group, LLC DBA Flourish Research

Miami, Florida, 33135, United States

Location

Cenexel IRA

Decatur, Georgia, 30030, United States

Location

DM Clinical Research - River Forest

River Forest, Illinois, 60305, United States

Location

JCCT

Lenexa, Kansas, 66219, United States

Location

Hassman Research Institute - Berlin - CenExel - PPDS

Marlton, New Jersey, 80530, United States

Location

DM Clinical Research - Philadelphia

Philadelphia, Pennsylvania, 19107, United States

Location

DM Clinical Research - Cyfair Clinical Research Center - PPDS

Houston, Texas, 77065-5685, United States

Location

Clinical Trials of Texas, LLC DBA Flourish Research

San Antonio, Texas, 78229, United States

Location

DM Clinical Research - Sugarland

Sugar Land, Texas, 77478, United States

Location

DM Clinical Research - Tomball MDC

Tomball, Texas, 77375, United States

Location

Centricity Research

Toronto, Ontario, M4G 3E8, Canada

Location

Centricity Research

Toronto, Ontario, M9W 4L6, Canada

Location

Centricity Research

Pointe-Claire, Quebec, H9R4S3, Canada

Location

Diex Recherche Sherbrooke Inc.

Sherbrooke, Quebec, J1L 0H8, Canada

Location

Diex Recherche Québec Inc.

Québec, G1V 4T3, Canada

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 18, 2024
• Study Start: July 15, 2024
• Primary Completion: September 25, 2025
• Study Completion: September 25, 2025
• Last Updated: October 14, 2025

Record last verified: 2025-10

Locations

CA (5); US (12)