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The purpose of this study is to evaluate the immunogenicity, reactogenicity, and safety, of mRNA-1083 multicomponent influenza and COVID-19 vaccine in adults ≥18 to <65 years of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mRNA-1083 Composition 1 Dose A Lot A | Experimental | Participants will receive single intramuscular (IM) injection of mRNA-1083 Composition 1 at Dose Level A Lot A on Day 1. |
|
| mRNA-1083 Composition 1 Dose A Lot B | Experimental | Participants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level A Lot B on Day 1. |
|
| mRNA-1083 Composition 1 Dose B | Experimental | Participants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level B on Day 1. |
|
| mRNA-1083 Composition 1 Dose C | Experimental | Participants will receive single IM injection of mRNA-1083 Composition 1 at Dose Level C on Day 1. |
|
| mRNA-1083 Composition 2 Dose A | Experimental | Participants will receive single IM injection of mRNA-1083 Composition 2 at Dose Level A on Day 1. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mRNA-1083 Composition 1 Dose A Lot A | Biological | Sterile liquid for injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titer (GMT) as Measured by Hemagglutination Inhibition (HAI) Assay for Influenza | Day 29 | |
| Geometric Mean Concentration (GMC) as Measured by Pseudovirus Neutralization Assay (PsVNA) for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) | Day 29 | |
| Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) | Day 1 through 7 days after study injection | |
| Number of Participants With Unsolicited Adverse Events (AEs) | Day 1 through 28 days after study injection | |
| Number of Participants With Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation From the Study | Day 1 through Day 181 |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza as Measured by HAI Assay | Baseline (Day 1), Day 29 | |
| GMFR of Antibodies for SARS-CoV-2 as Measured by PsVNA | Baseline (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 |
|---|---|---|---|---|---|---|
| Headlands Research Scottsdale | Scottsdale | Arizona | 85260 | United States | ||
| Artemis Research (Headlands) |
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| mRNA-1083 Composition 2 Dose B | Experimental | Participants will receive single IM injection of mRNA-1083 Composition 2 at Dose Level B on Day 1. |
|
| mRNA-1083 Composition 3 Dose A | Experimental | Participants will receive single IM injection of mRNA-1083 Composition 3 at Dose Level A on Day 1. |
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| mRNA-1083 Composition 3 Dose B | Experimental | Participants will receive single IM injection of mRNA-1083 Composition 3 at Dose Level B on Day 1. |
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| Influenza Vaccine | Active Comparator | Participants will receive single IM injection of Influenza Vaccine on Day 1. |
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| COVID-19 Vaccine | Active Comparator | Participants will receive single IM injection of COVID-19 Vaccine on Day 1. |
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| Investigational Influenza Vaccine | Active Comparator | Participants will receive single IM injection of Investigational Influenza Vaccine on Day 1. |
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| Investigational COVID-19 Vaccine Lot A | Active Comparator | Participants will receive single IM injection of Investigational COVID-19 Vaccine Lot A on Day 1. |
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| Investigational COVID-19 Vaccine Lot B | Active Comparator | Participants will receive single IM injection of Investigational COVID-19 Vaccine Lot B on Day 1. |
|
| mRNA-1083 Composition 1 Dose A Lot B | Biological | Sterile liquid for injection |
|
| mRNA-1083 Composition 1 Dose B | Biological | Sterile liquid for injection |
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| mRNA-1083 Composition 1 Dose C | Biological | Sterile liquid for injection |
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| mRNA-1083 Composition 2 Dose A | Biological | Sterile liquid for injection |
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| mRNA-1083 Composition 2 Dose B | Biological | Sterile liquid for injection |
|
| mRNA-1083 Composition 3 Dose A | Biological | Sterile liquid for injection |
|
| mRNA-1083 Composition 3 Dose B | Biological | Sterile liquid for injection |
|
| Influenza Vaccine | Biological | Sterile liquid for injection |
|
| COVID-19 Vaccine | Biological | Sterile liquid for injection |
|
| Investigational Influenza Vaccine | Biological | Sterile liquid for injection |
|
| Investigational COVID-19 Vaccine Lot A | Biological | Sterile liquid for injection |
|
| Investigational COVID-19 Vaccine Lot B | Biological | Sterile liquid for injection |
|
| Influenza: Percentage of Participants with Seroconversion as Measured by HAI Assay |
Seroconversion is defined as postinjection level ≥1:40 if baseline is <1:10 or at least a 4-fold rise if baseline is ≥1:10 in HAI antibody titer. |
| Baseline (Day 1) to Day 29 |
| SARS-CoV-2: Percentage of Participants with Seroresponse as Measured by PsVNA | Seroresponse is defined as PsVNA concentration change from preinjection baseline below the lower limit of quantification (LLOQ) to postinjection ≥4×LLOQ, or at least a 4-fold rise if baseline is ≥LLOQ. | Baseline (Day 1) to Day 29 |
| San Diego |
| California |
| 92103 |
| United States |
| Clinical Research Atlanta (Headlands) | Stockbridge | Georgia | 30281 | United States |
| Velocity Clinical Research, Boise | Meridian | Idaho | 83642 | United States |
| DM Clinical Research - Chicago | Melrose Park | Illinois | 60160 | United States |
| Velocity Clinical Research, Lafayette | Lafayette | Louisiana | 70809 | United States |
| Velocity Clinical Research, Rockville | Rockville | Maryland | 20854 | United States |
| DM Clinical Research - Boston | Brookline | Massachusetts | 02446 | United States |
| DM Clinical Research - Detroit | Southfield | Michigan | 48076 | United States |
| Velocity Clinical Research, Norfolk | Norfolk | Nebraska | 68701 | United States |
| Trial Management Associates, LLC | Wilmington | North Carolina | 28403 | United States |
| Velocity Clinical Research, Cincinnati, Mt. Auburn | Cincinnati | Ohio | 45219 | United States |
| Velocity Clinical Research, Cincinnati, Springdale | Cincinnati | Ohio | 45246 | United States |
| DM Clinical Research - Philadelphia | Philadelphia | Pennsylvania | 19107 | United States |
| Trial Management Associates, LLC | Myrtle Beach | South Carolina | 29572 | United States |
| DM Clinical Research - Bellaire | Houston | Texas | 77081 | United States |
| DM Clinical Research - Tomball | Tomball | Texas | 77375 | United States |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| D000086663 | COVID-19 Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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