Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2022-001545-20 | EudraCT Number |
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 main purpose of study is to evaluate the safety and immunogenicity of different dose levels of mRNA-1647 versus control in healthy cytomegalovirus (CMV)-seronegative and CMV-seropositive female and male participants 9 to 15 years of age. In addition, mRNA-1647 will be evaluated in female participants 16 to 25 years as a comparator cohort.
The study will be conducted in 2 parts: Part 1 Dose-Ranging and Part 2 Safety Expansion.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mRNA-1647 Dose A | Experimental | CMV-seronegative or CMV-seropositive participants 9 to 15 years of age will receive mRNA-1647 at Dose Level A by intramuscular (IM) injection given as a 3-injection series on Day 1, Month 2, and Month 6. |
|
| mRNA-1647 Dose B | Experimental | CMV-seronegative or CMV-seropositive participants 9 to 15 years of age will receive mRNA-1647 at Dose Level B by IM injection given as a 3-injection series on Day 1, Month 2, and Month 6. |
|
| mRNA-1647 Dose C | Experimental | CMV-seronegative or CMV-seropositive participants 9 to 15 years of age and 16 to 25 years of age will receive mRNA-1647 at Dose Level C by IM injection given as a 3-injection series on Day 1, Month 2, and Month 6. |
|
| Dose Expansion: mRNA-1647 (3-dose Schedule) | Experimental | CMV-seronegative or CMV-seropositive participants 9 to 15 years of age will receive mRNA-1647 at selected dose level by IM injection given as a 3-injection series on Day 1, Month 2, and Month 6. |
|
| Dose Expansion: mRNA-1647 (2-dose Schedule) | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mRNA-1647 | Biological | Sterile liquid for injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) | Up to Day 176 (7 days after each study injection) | |
| Number of Unsolicited Adverse Events (AEs) | Up to Day 197 (28 days after each study injection) | |
| Number of Medically Attended Adverse Events (MAAEs) | Up to Day 347 (6 months after the last study injection) | |
| Number of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and AEs Leading to Discontinuation | Up to Day 527 (end of study) | |
| Geometric Mean Titer (GMT) of Anti-CMV Neutralizing Antibodies (nAbs) | Serum functional antibody levels against vaccine antigens will be measured by nAb titer against epithelial cell infection and nAb titer against fibroblast infection. | Up to Day 527 (end of study) |
| Geometric Mean Fold-Rise (GMFR) of Anti-CMV nAbs | Serum functional antibody levels against vaccine antigens will be measured by nAb titer against epithelial cell infection and nAb titer against fibroblast infection. | Up to Day 527 (end of study) |
| Number of Participants with ≥2-Fold, 3-Fold, and 4-Fold increases Over Baseline of Anti-CMV Antibodies | Serum functional antibody levels against vaccine antigens will be measured by nAb titer against epithelial cell infection and nAb titer against fibroblast infection. | Up to Day 527 (end of study) |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Concentration (GMC) of Binding Anti-Glycoprotein B (gB) Specific Immunoglobulin G (IgG) and Anti-Pentamer Specific IgG | Serum antigen-specific binding antibody titers against vaccine antigens will be measured by enzyme-linked immunosorbent assay (ELISA) specific to the gB and pentamer proteins. | Up to Day 527 (end of study) |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other inclusion and exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paradigm Clinical Research Institute Inc - ClinEdge - PPDS | La Mesa | California | 91942-3189 | United States | ||
Not provided
Part 1: Dose-escalating, non-randomized Part 2: Randomized
Not provided
Not provided
Part 1 of this study will be open-label and blinding is not applicable. Part 2 of the study will be observer-blinded.
CMV-seronegative participants 9 to 15 years of age will receive mRNA-1647 at selected dose level by IM injection given as a 2-injection series on Day 1 and Month 6.
|
| Dose Expansion: Placebo (3-dose Schedule) | Placebo Comparator | CMV-seronegative or CMV-seropositive participants 9 to 15 years of age will receive placebo by IM injection given as a 3-injection series on Day 1, Month 2, and Month 6. |
|
| Dose Expansion: Placebo (2-dose Schedule) | Placebo Comparator | CMV-seronegative participants 9 to 15 years of age will receive placebo by IM injection given as a 2-injection series on Day 1 and Month 6. |
|
| Placebo | Other | 0.9% sodium chloride injection (normal saline) |
|
| Number of Participants with ≥2-Fold, 3-Fold, and 4-Fold Increases Over Baseline of Binding Anti-gB and Anti-pentamer Specific IgG |
Serum antigen-specific binding antibody titers against vaccine antigens will be measured by ELISA specific to the gB and pentamer proteins. |
| Up to Day 527 (end of study) |
| GMFR of Binding Anti-gB and Anti-pentamer Specific IgG | Serum antigen-specific binding antibody concentrations against vaccine antigens will be measured by ELISA specific to the gB and pentamer proteins. | Up to Day 527 (end of study) |
| Velocity Clinical Research - San Diego - PPDS |
| La Mesa |
| California |
| 91942 |
| United States |
| Benchmark Research - Sacramento -Hypercore- PPDS | Sacramento | California | 95864 | United States |
| Tekton Research - Fort Collins - Platinum - PPDS | Fort Collins | Colorado | 80525-5752 | United States |
| Velocity Clinical Research (Washington)- PPDS | Washington D.C. | District of Columbia | 20016 | United States |
| Prohealth Research Center | Doral | Florida | 33166-6613 | United States |
| University of Florida Jacksonville | Jacksonville | Florida | 32209 | United States |
| Clinical Neurosciences Solutions Inc. (Orlando-East South St) | Orlando | Florida | 32801-2987 | United States |
| Palm Harbor Dermatology | Tampa | Florida | 33609-2230 | United States |
| Santos Research Center | Tampa | Florida | 33615-3219 | United States |
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30322-1014 | United States |
| iResearch Atlanta - CenExel - PPDS | Decatur | Georgia | 30030-3438 | United States |
| Clinical Research Prime - ClinEdge - PPDS | Idaho Falls | Idaho | 83404-5305 | United States |
| Benchmark Research - Covington - HyperCore- PPDS | Covington | Louisiana | 70433 | United States |
| Tulane Medical Center | New Orleans | Louisiana | 70112-2632 | United States |
| University of Maryland School of Medicine | Baltimore | Maryland | 21201-1509 | United States |
| The Pediatric Centre | Columbia | Maryland | 21045 | United States |
| The Pediatric Centre of Frederick | Frederick | Maryland | 21702 | United States |
| Wayne State University | Detroit | Michigan | 48201 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Velocity Clinical Research - Gulfport | Gulfport | Mississippi | 39503 | United States |
| Velocity Clinical Research (Lincoln-Nebraska) - PPDS | Lincoln | Nebraska | 68510 | United States |
| Velocity Clinical Research (Norfolk - Nebraska) - PPDS | Norfolk | Nebraska | 68701-7701 | United States |
| Velocity Clinical Research (Omaha-Nebraska) - Platinum - PPDS | Omaha | Nebraska | 68134-3664 | United States |
| Albuquerque Clinical Trials Inc - Clinedge - PPDS | Albuquerque | New Mexico | 87102-2619 | United States |
| Velocity Clinical Research -Albuquerque -PPDS | Albuquerque | New Mexico | 87102-3644 | United States |
| Velocity Clinical Research (Binghamton - New York) - PPDS | Binghamton | New York | 13901-1046 | United States |
| Rochester Clinical Research, Inc | Rochester | New York | 14609-3173 | United States |
| OnSite Clinical Solutions, LLC - ClinEdge - PPDS | Charlotte | North Carolina | 28277-4859 | United States |
| Tekton Research - Oklahoma- PPDS | Edmond | Oklahoma | 73013 | United States |
| Lynn Institute of Norman - ERN - PPDS | Norman | Oklahoma | 73072-3251 | United States |
| Velocity Clinical Research - Medford - PPDS | Medford | Oregon | 97504-7738 | United States |
| Meharry Medical College | Nashville | Tennessee | 37208 | United States |
| Tekton Research - Texas - PPDS | Austin | Texas | 78705 | United States |
| Tekton Research - Beaumont - Platinum - PPDS | Beaumont | Texas | 77706-3061 | United States |
| Benchmark Research - Fort Worth - HyperCore -PPDS | Fort Worth | Texas | 76135 | United States |
| University of Texas Medical Branch (UTMB) | Galveston | Texas | 77550 | United States |
| West Houston Clinical Research - Hunt - PPDS | Houston | Texas | 77055-1626 | United States |
| Victoria Clinical Research Group | Port Lavaca | Texas | 77979 | United States |
| Benchmark Research - San Angelo - HyperCore - PPDS | San Angelo | Texas | 76904 | United States |
| Tekton Research - Texas - Platinum - PPDS | San Antonio | Texas | 78229 | United States |
| DM Clinical Research - ERN- PPDS | Tomball | Texas | 77375 | United States |
| Crossroads Clinical Research (Victoria) | Victoria | Texas | 77901 | United States |
| JBR Clinical Research - CenExel JBR - PPDS | Salt Lake City | Utah | 84107-4536 | United States |
| M.A.G.I.C. Clinic Ltd. Metabolics and Genetics in Calgary | Calgary | Alberta | Canada |
| ALTA Clinical Research Inc | Edmonton | Alberta | Canada |
| CARe Clinic | Red Deer | Alberta | Canada |
| Canadian Center for Vaccinology | Halifax | Nova Scotia | Canada |
| Hamilton Medical Research Group | Hamilton | Ontario | Canada |
| Bluewater Clinical Research Group | Sarnia | Ontario | Canada |
| Centre Hospitalier Universitaire Sainte-Justine | Montreal | Quebec | Canada |
| Southampton General Hospital | Southampton | Hampshire | United Kingdom |
| Lakeside Healthcare | Corby | Northamptonshire | United Kingdom |
| Sheffield Children's Hospital | Sheffield | South Yorkshire | United Kingdom |
| Queen Elizabeth Hospital | Birmingham | United Kingdom |
| Noah's Ark Children's Hospital for Wales | Cardiff | United Kingdom |
| St. George Hospital | London | United Kingdom |
| ID | Term |
|---|---|
| C000722750 | mRNA-1647 cytomegalovirus vaccine |
Not provided
Not provided
Not provided