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)
Completed · Phase 2
Conditions studied: Influenza, SARS-CoV-2
In brief
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.
Key facts
- Study ID
- NCT06508320
- Run by
- ModernaTX, Inc.
- People needed
- 932
- Starts
- 2024-07-15
- Expected to finish
- 2025-09-25
- Last updated by the study team
- 2025-10-14
Who can join
Age: 50 and older, up to 64. Sex: any. Healthy volunteers: accepted.
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.
- Other protocol-defined inclusion/exclusion criteria may apply.
Where it is running
- 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
Full record on ClinicalTrials.gov
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