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The purpose of this first-in-human study is to evaluate the safety and immunogenicity of mRNA-1468.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: mRNA-1468: Dose 1 | Experimental | Participants will receive placebo by intramuscular (IM) injection on Day 1 followed with mRNA-1468 by IM injection on Day 57 in Part 1. |
|
| Part 1: mRNA-1468: Dose 2 | Experimental | Participants will receive mRNA-1468 by IM injection on Day 1 and Day 57 in Part 1. |
|
| Part 1: mRNA-1468: Dose 3 | Experimental | Participants will receive mRNA-1468 by IM injection on Day 1 and Day 57 in Part 1. |
|
| Part 1: mRNA-1468: Dose 4 | Experimental | Participants will receive mRNA-1468 by IM injection on Day 1 and Day 57 in Part 1. |
|
| Part 1: Shingrix | Active Comparator | Participants will receive Shingrix by IM injection on Day 1 and Day 57 in Part 1. |
|
| Part 2: mRNA-1468: Dose 5 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mRNA-1468 | Biological | Sterile liquid dispersion for injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions | Up to Day 64 (7 days after each injection) | |
| Number of Participants with Unsolicited Adverse Events (AEs) | Up to Day 85 (28 days after each injection) | |
| Number of Participants with Serious AEs, AEs Leading to Discontinuation of Study Vaccine or Withdrawal From the Study, and AEs of Special Interest | Day 1 to End of Study (up to a maximum of Day 1113) | |
| Number of Participants with Medically Attended AEs | Day 1 to Day 393 (12 months after last study injection) |
| Measure | Description | Time Frame |
|---|---|---|
| Vaccine Seroresponse Rate of Participants | Vaccine seroresponse will be defined as an anti-glycoprotein E (gE)-specific binding antibody (bAb) concentration ≥4-fold if baseline bAb concentration is above the lower limit of quantification (LLOQ) or ≥4 * LLOQ if baseline bAb concentration is \ | Day 85 and Day 225 (1 and 6 months after the last injection) |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Velocity Clinical Research - Westlake | Los Angeles | California | 90057 | United States | ||
| Tekton Research, Inc - Longmont Center |
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| Experimental |
Participants will receive mRNA-1468 by IM injection on Day 1 and Day 57 in Part 2. |
|
| Part 2: mRNA-1468: Dose 6 | Experimental | Participants will receive mRNA-1468 by IM injection on Day 1 and Day 57 in Part 2. |
|
| Part 2: Shingrix | Active Comparator | Participants will receive Shingrix by IM injection on Day 1 and Day 57 in Part 2. |
|
| Placebo | Biological | Sterile liquid for injection |
|
|
| Shingrix | Biological | Sterile suspension for injection |
|
| Geometric Mean Concentration of Anti-gE-specific bAb as Measured by Enzyme-linked Immunosorbent Assay | Day 85 and Day 225 (1 and 6 months after the last injection) |
| Change from Baseline in Geometric Mean Fold Rise of Anti-gE-specific bAb Concentration | Baseline, Day 85 and Day 225 (1 and 6 months after the last injection) |
| Longmont |
| Colorado |
| 80501 |
| United States |
| Meridien Research | Lakeland | Florida | 33805 | United States |
| Clinical Trials of Florida, LLC | Miami | Florida | 33186 | United States |
| Floridian Clinical Research | Miami Lakes | Florida | 33016 | United States |
| Florida Pulmonary Research Institute, LLC | Winter Park | Florida | 32789 | United States |
| Centricity Research | Columbus | Georgia | 31904 | United States |
| Great Lakes | Chicago | Illinois | 60640 | United States |
| DM Clinical Research- River Forest | River Forest | Illinois | 60305 | United States |
| Meridian Clinical Research - Dakota Dunes | Sioux City | Iowa | 51106 | United States |
| Johnson County Clin-Trials (JCCT) | Lenexa | Kansas | 66219 | United States |
| NOLA Research Works | New Orleans | Louisiana | 70115 | United States |
| Velocity Clinical Research - Medford | Medford | Oregon | 97504 | United States |
| DM Clinical Research - Philadelphia | Philadelphia | Pennsylvania | 19107 | United States |
| WR-ClinSearch, LLC | Chattanooga | Tennessee | 37421 | United States |
| Tekton Research | Austin | Texas | 78745 | United States |
| Gadolin Research | Beaumont | Texas | 77702 | United States |
| LinQ Research, LLC | Houston | Texas | 77087 | United States |
| DM Clinical Research | Tomball | Texas | 77375 | United States |
| Research Works San Juan | San Juan | 00907 | Puerto Rico |
| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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