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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.
The study will be comprised of 2 parts, Parts 1 and 2. In Part 1, participants will be randomized into 4 study groups (Lots A, B, C, and D). Upon completion of Part 1, participants will be randomized into 2 study groups (Lots A and E) in Part 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
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| Part 2 Group 6: mRNA-1083 Lot E |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mRNA-1083 | Biological | IM injection in a deltoid muscle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indago Research & Health Center, Inc. | Hialeah | Florida | 33012 | United States | ||
| Cenexel RCA |
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Participants will receive mRNA-1083 Lot E as a single injection on Day 1 in Part 2. |
|
| 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 |
| Hollywood |
| Florida |
| 33024 |
| United States |
| Suncoast Research Group, LLC DBA Flourish Research | Miami | Florida | 33135 | United States |
| Cenexel IRA | Decatur | Georgia | 30030 | United States |
| DM Clinical Research - River Forest | River Forest | Illinois | 60305 | United States |
| JCCT | Lenexa | Kansas | 66219 | United States |
| Hassman Research Institute - Berlin - CenExel - PPDS | Marlton | New Jersey | 80530 | United States |
| DM Clinical Research - Philadelphia | Philadelphia | Pennsylvania | 19107 | United States |
| DM Clinical Research - Cyfair Clinical Research Center - PPDS | Houston | Texas | 77065-5685 | United States |
| Clinical Trials of Texas, LLC DBA Flourish Research | San Antonio | Texas | 78229 | United States |
| DM Clinical Research - Sugarland | Sugar Land | Texas | 77478 | United States |
| DM Clinical Research - Tomball MDC | Tomball | Texas | 77375 | United States |
| Centricity Research | Toronto | Ontario | M4G 3E8 | Canada |
| Centricity Research | Toronto | Ontario | M9W 4L6 | Canada |
| Centricity Research | Pointe-Claire | Quebec | H9R4S3 | Canada |
| Diex Recherche Sherbrooke Inc. | Sherbrooke | Quebec | J1L 0H8 | Canada |
| Diex Recherche Québec Inc. | Québec | G1V 4T3 | Canada |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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