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This clinical study will assess the safety and immunogenicity of 2 dose levels of mRNA-1653, a combined human metapneumovirus and human parainfluenza virus type 3 vaccine, in healthy adults (18 to 49 years of age) and 2 dose levels in children (12 to 59 months of age) with serologic evidence of prior exposure. The safety profile of the adult cohort will permit enrollment of the pediatric cohort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mRNA-1653, Adult participants | Experimental | Participants will receive 1 of 2 doses of mRNA-1653, administered via intramuscular injection, on Day 1 and Day 57. |
|
| mRNA-1653 Pediatric participants | Experimental | Participants will receive 1 of 2 possible doses of mRNA-1653, administered via intramuscular injection, on Day 1 and Day 57. |
|
| Placebo, Adult participants | Placebo Comparator | Participants will receive mRNA-1653-matching placebo, administered via intramuscular injection, on Day 1 and Day 57. |
|
| Placebo, Pediatric participants | Placebo Comparator | Participants will receive mRNA-1653-matching placebo, administered via intramuscular injection, on Day 1 and Day 57. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mRNA-1653 | Biological | Sterile liquid for injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants with Solicited Local and Systemic Adverse Reactions (ARs) | Up to 7 days after each dose administration | |
| Proportion of Participants with Unsolicited Adverse Events (AEs) | Up to 28 days after each dose administration | |
| Proportion of Participants with Serious Adverse Events (SAEs) and Medically-Attended AEs | Up to 1 year after the last dose administration |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean titer (GMT) of Serum Anti-hMPV and Anti-PIV3 Neutralizing Antibodies | Day 29, 57, 85, and 224 for adults; Day 29 and 85 for pediatric participants | |
| Geometric Mean Ratio (GMR) of Post-Baseline/Baseline Titers of Serum Anti-hMPV and Anti-PIV3 Neutralizing Antibodies |
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Key Inclusion Criteria:
Specific inclusion criteria for adults 18 to 49 years of age:
Specific inclusion criteria for children 12 to 59 months of age:
Key Exclusion Criteria:
Adult and pediatric participants eligible for this study must not meet any of the following criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Research Associates Inc | Birmingham | Alabama | 35205 | United States | ||
| Meridian Clinical Research |
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Parallel for the Adult Cohort, followed by Sequential Assignment for the Pediatric Cohort
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Observer blind
| Placebo | Biological | Sterile liquid for injection |
|
|
| Day 29, 57, 85, and 224 for adults; Day 29 and 85 for pediatric participants |
| Proportion of Participants with ≥2-Fold and ≥4-Fold Increases in Serum Anti-hMPV or Anti-PIV3 Neutralizing Antibody Titer from Baseline | Day 29, 57, 85, and 224 for adults; Day 29 and 85 for pediatric participants |
| Washington D.C. |
| District of Columbia |
| 20016 |
| United States |
| Clinical Research Prime | Idaho Falls | Idaho | 83404 | United States |
| Heartland Research Associates LLC | El Dorado | Kansas | 67042 | United States |
| Heartland Research Associates LLC | Newton | Kansas | 67114 | United States |
| MedPharmics | Metairie | Louisiana | 70006 | United States |
| Meridian Clinical Research, LLC | Lincoln | Nebraska | 68510 | United States |
| Meridian Clinical Research | Norfolk | Nebraska | 68701 | United States |
| Meridian Clinical Research, LLC | Omaha | Nebraska | 68134 | United States |
| UHS Primary Care | Binghamton | New York | 13901 | United States |
| Child Healthcare Associates | Liverpool | New York | 13090 | United States |
| Child Healthcare Assoc. | Syracuse | New York | 13057 | United States |
| Duke Vaccine and Trials Unit | Durham | North Carolina | 27710 | United States |
| Ohio Pediatric Research Assn Inc | Dayton | Ohio | 45414 | United States |
| Sanford Children's Hospital | Sioux Falls | South Dakota | 57117 | United States |
| Crossroads Clinical Research | Corpus Christi | Texas | 78413 | United States |
| University of Texas Medical Branch (UTMB) | Galveston | Texas | 77555 | United States |
| Tekton Research Inc | San Antonio | Texas | 78240 | United States |
| Tanner Clinic | Layton | Utah | 84041 | United States |
| ID | Term |
|---|---|
| D014777 | Virus Diseases |
| D012327 | RNA Virus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| ID | Term |
|---|---|
| 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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