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The main goal of this study is to evaluate the safety, reactogenicity, and immunogenicity of study vaccines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: mRNA-1345 | Experimental | Participants will receive single intramuscular (IM) injection of mRNA-1345 on Day 1. |
|
| Part 1: mRNA-1647 2-Dose | Experimental | Participants will receive single IM injection of mRNA-1647 on Days 1 and 57. |
|
| Part 1: mRNA-1647 3-Dose | Experimental | Participants will receive single IM injection of mRNA-1647 on Days 1, 57, and 169. |
|
| Part 2: mRNA-1273 | Experimental | Participants will receive single IM injection of mRNA-1273 on Day 1 |
|
| Part 2: mRNA-1010 | Experimental | Participants will receive single IM injection of mRNA-1010 on Day 1. |
|
| Part 2: FLUAD® | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mRNA-1273 | Biological | Sterile liquid for injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) | Up to Day 176 (7 days follow-up post-vaccination) | |
| Number of Participants With Unsolicited Adverse Events (AEs) | Up to Day 197 (28 days follow-up post-vaccination) | |
| Number of Participants With Serious AEs (SAEs), AEs of Special Interest (AESIs), and AEs Leading to Study Withdrawal or Discontinuation of Study Vaccination | Day 1 through end of study (EOS) (up to Day 1249) | |
| Number of Participants with Medically Attended Adverse Events (MAAEs) | Day 1 through Day 361 |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titer (GMT) of Serum Neutralizing Antibody Response for mRNA-1010 (and Licensed Influenza Vaccine Comparator), mRNA-1273, and mRNA-1345 | Days 1 (Baseline), 29, 85, and 197 | |
| Geometric Mean Fold-Rise (GMFR) of Serum Neutralizing Antibody Response for mRNA-1010 (and Licensed Influenza Vaccine Comparator), mRNA-1273, and mRNA-1345 |
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Inclusion Criteria:
Exclusion Criteria:
Other inclusion and exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CenExel | Hollywood | Florida | 33024 | United States | ||
| Meridian Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41535296 | Derived | Henry C, Makrinos D, Liu R, Cavallaro M, Fenderson B, Sun Y, Chang X, Astley E, Girard B, Yu WH, Oostendorp J, DiPiazza A, Paris R. An mRNA influenza vaccine induces immunity comparable to an adjuvanted vaccine in a randomized trial. NPJ Vaccines. 2026 Jan 14;11(1):50. doi: 10.1038/s41541-026-01370-7. | |
| 41398408 | Derived |
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| ID | Term |
|---|---|
| D018352 | Coronavirus Infections |
| D014777 | Virus Diseases |
| D000086382 | COVID-19 |
| D007251 | Influenza, Human |
| D003586 | Cytomegalovirus Infections |
| ID | Term |
|---|---|
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000090983 | 2019-nCoV Vaccine mRNA-1273 |
| C000722747 | mRNA-1010 influenza vaccine |
| C000722749 | mRNA-1345 respiratory syncytial virus vaccine |
| C478243 | fluad vaccine |
| C000722750 | mRNA-1647 cytomegalovirus vaccine |
| ID | Term |
|---|---|
| D000087503 | mRNA Vaccines |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
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Participants will receive single IM injection of FLUAD® on Day 1.
|
| mRNA-1010 |
| Biological |
Sterile liquid for injection |
|
| mRNA-1345 | Biological | Sterile liquid for injection |
|
| FLUAD® | Biological | adjuvanted (MF59), inactivated, quadrivalent seasonal influenza vaccine |
|
| mRNA-1647 | Biological | Sterile lyophilized product |
|
| Days 1 (Baseline), 29, 85, and 197 |
| Percentage of Participants With Seroresponse for mRNA-1010 (and Licensed Influenza Vaccine Comparator), mRNA-1273, mRNA-1345, and mRNA-1647 | Days 1 (Baseline), 29, 85, and 197 |
| Savannah |
| Georgia |
| 31406 |
| United States |
| Meridian Clinical Research | Sioux City | Iowa | 51106 | United States |
| Johnson County Clinical Trials | Lenexa | Kansas | 66219 | United States |
| Meridian Clinical Research | Lincoln | Nebraska | 68510 | United States |
| Benchmark Research | Austin | Texas | 78705 | United States |
| Tekton Research, Inc | Austin | Texas | 78745 | United States |
| DM Clinical Research- Texas Center for Drug Development | Houston | Texas | 77081 | United States |
| Kaplonek P, Vargas R, Lee JS, Bertera H, Astley E, Girard B, Oostendorp J, Henry C, Paris R, Yu WH, Alter G. mRNA-1010 influenza vaccine elicits distinct and enhanced humoral immunity compared to adjuvanted inactivated vaccines. NPJ Vaccines. 2025 Dec 15;11(1):19. doi: 10.1038/s41541-025-01340-5. |
| 40276503 | Derived | Fierro C, Sanchez-Crespo N, Makrinos D, Zhang W, Sun Y, Rohilla P, Girard B, Adeniji A, DiPiazza A, Paris R. Shared clinical and immunologic features of mRNA vaccines: preliminary results from a comparative clinical study. Front Immunol. 2025 Apr 10;16:1501275. doi: 10.3389/fimmu.2025.1501275. eCollection 2025. |
| D011024 |
| Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009976 | Orthomyxoviridae Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |
| D000941 | Antigens |
| D001685 | Biological Factors |