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This clinical study will assess the safety, reactogenicity and immunogenicity of mRNA-1653, a combined human metapneumovirus and human parainfluenza virus type 3 vaccine in healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mRNA-1653 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mRNA-1653 | Biological | Escalating dose levels |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of solicited AEs (local and systemic reactogenicity events) | 7 days following each dose administration | |
| Frequency of unsolicited adverse events | 28 days following each dose administration | |
| Frequency of serious adverse events (SAE), adverse events of special interest (AESI), and medically-attended AEs | one year following the last dose administration | |
| Frequency of clinical laboratory adverse events | 1 month following the last dose administration | |
| Geometric mean titer (GMT) of the serum anti-hMPV and anti-PIV3 neutralizing antibodies | 1 month following the last dose administration | |
| Proportion of subjects with a ≥ 4-fold increase in serum anti-hMPV and anti-PIV3 neutralizing antibody titer from baseline to post-vaccination | 1 month following the last dose administration | |
| Proportion of subjects who achieve serum anti-hMPV and anti-PIV3 neutralizing antibody titers greater than the third quartile of the serum anti-hMPV and anti-PIV3 antibody titers overall distribution at baseline | 1 month following the last dose administration |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean titer (GMT) of the serum anti-hMPV and anti-PIV3 neutralizing antibodies | 6 months and 1 year following the last dose administration | |
| Proportion of subjects with a ≥ 4-fold increase in serum anti-hMPV and anti-PIV3 neutralizing antibody titer from baseline to post-vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meridian Clinical Research, LLC | Omaha | Nebraska | 68134 | United States | ||
| Benchmark Research |
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| Other |
Saline |
|
| 6 months and 1 year following the last dose administration |
| Proportion of subjects who achieve serum anti-hMPV and anti-PIV3 neutralizing antibody titers greater than the third quartile of the serum anti-hMPV and anti-PIV3 antibody titers overall distribution at baseline | 6 months and 1 year following the last dose administration |
| Austin |
| Texas |
| 78705 |
| United States |
| Benchmark Research | Fort Worth | Texas | 76135 | United States |