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)
NCT ID: NCT06508320
Last Updated: 2025-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
932 participants
INTERVENTIONAL
2024-07-15
2025-09-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Part 1 Group 1: mRNA-1083 Lot A
Participants will receive mRNA-1083 Lot A as a single injection on Day 1 in Part 1.
mRNA-1083
IM injection in a deltoid muscle.
Part 1 Group 2: mRNA-1083 Lot B
Participants will receive mRNA-1083 Lot B as a single injection on Day 1 in Part 1.
mRNA-1083
IM injection in a deltoid muscle.
Part 1 Group 3: mRNA-1083 Lot C
Participants will receive mRNA-1083 Lot C as a single injection on Day 1 in Part 1.
mRNA-1083
IM injection in a deltoid muscle.
Part 1 Group 4: mRNA-1083 Lot D
Participants will receive mRNA-1083 Lot D as a single injection on Day 1 in Part 1.
mRNA-1083
IM injection in a deltoid muscle.
Part 2 Group 5: mRNA-1083 Lot A
Participants will receive mRNA-1083 Lot A as a single injection on Day 1 in Part 2.
mRNA-1083
IM injection in a deltoid muscle.
Part 2 Group 6: mRNA-1083 Lot E
Participants will receive mRNA-1083 Lot E as a single injection on Day 1 in Part 2.
mRNA-1083
IM injection in a deltoid muscle.
Interventions
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mRNA-1083
IM injection in a deltoid muscle.
Eligibility Criteria
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Inclusion Criteria
2. Participants of nonchildbearing potential may be enrolled in the study.
3. Participants who could become pregnant: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy.
4. 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.
5. Have received an influenza vaccine in the previous season (since September 2023 for Part 1, since Sep 2024 for Part 2).
Exclusion Criteria
2. Reported history of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infections.
3. 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.
4. 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.
5. 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.
6. 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.
7. Received a licensed seasonal influenza vaccine within 150 days prior to Day 1.
8. Received a licensed/authorized SARS-CoV-2 vaccine within 90 days prior to Day 1.
9. 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.
50 Years
64 Years
ALL
Yes
Sponsors
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ModernaTX, Inc.
INDUSTRY
Responsible Party
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Locations
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Indago Research & Health Center, Inc.
Hialeah, Florida, United States
Cenexel RCA
Hollywood, Florida, United States
Suncoast Research Group, LLC DBA Flourish Research
Miami, Florida, United States
Cenexel IRA
Decatur, Georgia, United States
DM Clinical Research - River Forest
River Forest, Illinois, United States
JCCT
Lenexa, Kansas, United States
Hassman Research Institute - Berlin - CenExel - PPDS
Marlton, New Jersey, United States
DM Clinical Research - Philadelphia
Philadelphia, Pennsylvania, United States
DM Clinical Research - Cyfair Clinical Research Center - PPDS
Houston, Texas, United States
Clinical Trials of Texas, LLC DBA Flourish Research
San Antonio, Texas, United States
DM Clinical Research - Sugarland
Sugar Land, Texas, United States
DM Clinical Research - Tomball MDC
Tomball, Texas, United States
Centricity Research
Toronto, Ontario, Canada
Centricity Research
Toronto, Ontario, Canada
Centricity Research
Pointe-Claire, Quebec, Canada
Diex Recherche Sherbrooke Inc.
Sherbrooke, Quebec, Canada
Diex Recherche Québec Inc.
Québec, , Canada
Countries
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Other Identifiers
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mRNA-1083-P201
Identifier Type: -
Identifier Source: org_study_id
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