Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the Part A Phase 1 of this study is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1403 and mRNA-1405 in healthy adult participants 18 to 49 years of age and 60 to 80 years of age. The purpose of Part B Phase 2 and Part C Phase 2 is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1403 in healthy adult participants (18 to 80 years of age).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 Part A: mRNA-1403 Dose Level 1 | Experimental | Participants will receive 2 intramuscular (IM) injections of mRNA-1403 at Dose Level 1. |
|
| Phase 1 Part A: mRNA-1403 Dose Level 2 | Experimental | Participants will receive 2 IM injections of mRNA-1403 at Dose Level 2. |
|
| Phase 1 Part A: mRNA-1403 Dose Level 3 | Experimental | Participants will receive 2 IM injections of mRNA-1403 at Dose Level 3. |
|
| Phase 1 Part A: mRNA-1403 Dose Level 4 Regimen 1 | Experimental | Participants will receive 2 IM injections of mRNA-1403 at Dose Level 4. |
|
| Phase 1 Part A: mRNA-1403 Dose Level 4 Regimen 2 | Experimental | Participants will receive 1 IM injection of mRNA-1403 at Dose Level 4 and 1 IM injection of study vaccine-matching placebo. |
|
| Phase 1 Part A: mRNA-1405 Dose Level 1 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mRNA-1403 | Biological | Sterile liquid for injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) | Up to a maximum of Day 36 (7 days after each study injection) | |
| Number of Participants with Unsolicited Adverse Events (AEs) | Up to a maximum of Day 57 (28 days after each study injection) | |
| Number of Participants with Medically Attended AEs (MAAEs) | Day 1 up to a maximum of Day 546 | |
| Number of Participants with Any Serious Adverse Events (SAEs), AEs Leading to Withdrawal From Study, and Adverse Events of Special Interest (AESIs) | Day 1 up to a maximum of Day 730 |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Titers (GMT) of Histo-blood Group Antigen (HBGA)-blocking Antibodies Against Vaccine-matched Norovirus (NoV) Genotypes | Phase 1: Days 1, 29, and 57; Phase 2: Days 1, 29, 169, 365, and 393 | |
| Geometric Mean Fold Rise (GMFR) of HBGA-blocking Antibodies Titers |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
(drugs or biologics). The use of topical corticosteroids or other immunosuppressive agents (for example, topical calcineurin inhibitor) may be eligible for participation at the discretion of the Investigator.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ARK Clinical Research, LLC | Long Beach | California | 90815 | United States | ||
| Tekton Research, Inc - Longmont Center |
Not provided
Not provided
Not provided
Not provided
Not provided
| Experimental |
Participants will receive 2 IM injections of mRNA-1405 at Dose Level 1. |
|
| Phase 1 Part A: mRNA-1405 Dose Level 2 | Experimental | Participants will receive 2 IM injections of mRNA-1405 at Dose Level 2. |
|
| Phase 1 Part A: mRNA-1405 Dose Level 3 | Experimental | Participants will receive 2 IM injections of mRNA-1405 at Dose Level 3. |
|
| Phase 1 Part A: mRNA-1405 Dose Level 4 Regimen 1 | Experimental | Participants will receive 2 IM injections of mRNA-1405 at Dose Level 4. |
|
| Phase 1 Part A: mRNA-1405 Dose Level 4 Regimen 2 | Experimental | Participants will receive 1 IM injections of mRNA-1405 at Dose Level 4 and 1 IM injection of study vaccine-matching placebo. |
|
| Phase 1 Part A: Placebo | Placebo Comparator | Participants will receive 2 IM injections of study vaccine-matching placebo. |
|
| Phase 2 Part B: mRNA-1403 Dose Level 1 | Experimental | Participants will receive 1 IM injection of mRNA-1403 at Dose Level 1. |
|
| Phase 2 Part B: mRNA-1403 Dose Level 2 | Experimental | Participants will receive 1 IM injection of mRNA-1403 at Dose Level 2 and if participating in the booster extension will receive a second dose of study vaccine-matching placebo 12-15 months after first dose. |
|
| Phase 2 Part B: mRNA-1403 Dose Level 3 | Experimental | Participants will receive 1 IM injection of mRNA-1403 at Dose Level 3 and if participating in the booster extension will receive a second dose of mRNA-1403 at Dose Level 3 12-15 months after first dose. |
|
| Phase 2 Part B: Placebo | Placebo Comparator | Participants will receive 1 IM injection of study vaccine-matching placebo. |
|
| Phase 2 Part C: mRNA-1403 Dose Level 3 | Experimental | Participants will receive 1 IM injection of mRNA-1403 at Dose Level 3. |
|
| Phase 2 Part C: Placebo | Placebo Comparator | Participants will receive 1 IM injection of study vaccine-matching placebo. |
|
| mRNA-1405 | Biological | Sterile liquid for injection |
|
| Placebo | Biological | 0.9% sodium chloride (normal saline) injection |
|
| Phase 1: Days 29, and 57; Phase 2: Days 29, 169, 365, and 393 |
| Percentage of Participants with Seroresponse Based on HBGA-blocking Antibody Titers | Phase 1: Days 29, and 57; Phase 2: Days 29, 169, and 393 |
| Geometric Mean Concentration (GMC) of Binding Antibody (bAb) Against Vaccine-matched NoV Genotypes | Days 1, 29, and 57 |
| GMFR of bAb Levels | Days 29 and 57 |
| Percentage of Participants with Seroresponse Based on bAb Levels | Days 29 and 57 |
| Longmont |
| Colorado |
| 80501 |
| United States |
| Research Centers of America | Hollywood | Florida | 33024 | United States |
| Accel Research Sites Network | Decatur | Georgia | 30030 | United States |
| Velocity Clinical Research - Boise | Meridian | Idaho | 83642 | United States |
| Optimal Research | Peoria | Illinois | 61614 | United States |
| Velocity Clinical Research | Sioux City | Iowa | 51106 | United States |
| Johnson County Clin-Trials (JCCT) | Lenexa | Kansas | 66219 | United States |
| Velocity Clinical Research | Rockville | Maryland | 20854 | United States |
| Velocity Clinical Research | Norfolk | Nebraska | 68701 | United States |
| Velocity Clinical Research | Omaha | Nebraska | 68134 | United States |
| Rochester Clinical Research, Inc | Rochester | New York | 14609 | United States |
| Epic Medical Research, LLC | Red Oak | Texas | 75154 | United States |
| JBR Clinical Research | Salt Lake City | Utah | 84107 | United States |
| Emeritus Research Camberwell | Camberwell | Australia |
| Nucleus Network | Melbourne | Australia |