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The purpose of this study is to evaluate safety, tolerability and immunogenicity of mRNA-1345 in participants who have been previously vaccinated with either Arexvy or Abrysvo at least 12 months prior to enrollment, are medically stable and aged ≥60 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mRNA-1345 | Experimental | Participants will receive a single dose of mRNA-1345 injection administered intramuscularly on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mRNA-1345 | Biological | Suspension for injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) | Day 1 up to Day 7 (7 days post-injection) | |
| Number of Participants with Unsolicited Adverse Events (AEs) | Day 1 up to Day 28 (28 days post-injection) | |
| Number of Participants with Medically Attended AEs (MAAEs), Serious AEs (SAEs), AEs of Special Interest (AESIs), and AEs Leading to Discontinuation | Day 1 up to Day 181 (End of study) | |
| Geometric Mean Titer (GMT) of Serum RSV-A Neutralizing Antibodies (Abs) at Day 29 | Day 29 | |
| GMT of Serum RSV-B Neutralizing Abs at Day 29 | Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| GMT of Serum RSV-A Neutralizing Abs | Day 1 up to Day 181 (End of study) | |
| Geometric Mean Fold Rise (GMFR) of Serum RSV-A Neutralizing Abs | Day 181 | |
| GMT of Serum RSV-B Neutralizing Abs |
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Key Inclusion Criteria:
Participants may have one or more chronic medical diagnoses, but should be medically stable as assessed by:
Participant has received a single dose of Arexvy or Abrysvo at least 12 months prior to Visit 1. Participants must provide proof of RSV vaccination status (including brand and date received) prior to enrollment.
Key Exclusion Criteria:
Other protocol-specified inclusion and/or exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Velocity Clinical Research, Denver | Denver | Colorado | 80110 | United States | ||
| Indago Research & Health Center, Inc. |
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| Day 1 up to Day 181 (End of study) |
| GMFR of Serum RSV-B Neutralizing Abs | Day 181 |
| Percentage of Participants With Seroresponse in RSV-A Neutralizing Abs | Day 181 |
| Percentage of Participants With Seroresponse in RSV-B Neutralizing Abs | Day 181 |
| Percentage of Participants With ≥2-fold Increase From Baseline in RSV-A Neutralizing Ab Titers | Day 181 |
| Percentage of Participants With ≥2-fold Increase From Baseline in RSV-B Neutralizing Ab Titers | Day 181 |
| Hialeah |
| Florida |
| 33012 |
| United States |
| Velocity Clinical Research, Savannah | Savannah | Georgia | 31406 | United States |
| Velocity Clinical Research, Valparaiso | Valparaiso | Indiana | 46383 | United States |
| Velocity Clinical Research, Covington | Covington | Louisiana | 70433 | United States |
| Velocity Clinical Research, Rockville | Rockville | Maryland | 20854 | United States |
| Velocity Clinical Research, Lincoln | Lincoln | Nebraska | 68510 | United States |
| Velocity Clinical Research, Medford | Medford | Oregon | 97504 | United States |
| Velocity Clinical Research, Austin | Austin | Texas | 78759 | United States |
| Velocity Clinical Research, Hampton | Hampton | Virginia | 23666 | United States |
| Velocity Clinical Research, Spokane | Spokane | Washington | 99218 | United States |
| ID | Term |
|---|---|
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000722749 | mRNA-1345 respiratory syncytial virus vaccine |
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