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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-000502-15 | EudraCT Number |
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Part A: The purpose is to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1345 in children aged 2 to <5 years (Cohort 1) and in children at high risk of respiratory syncytial virus (RSV) disease 5 to <18 years of age (Cohort 2) to inform the dose level selection for the next phase of development (Phase 3).
Part B: The purpose is to provide surveillance for RSV disease for the next RSV season (6 months after re-enrollment) and safety follow-up for Cohort 1 participants that were enrolled and dosed in Part A.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A and Part B: Cohort 1 (2 to <5 Years of Age) | Experimental | Part A: Participants 2 to <5 years of age will receive either a single intramuscular (IM) injection of mRNA-1345 or placebo on Day 1. Part B: Participants will have the option to be re-enrolled into a 6-month safety-follow up period. |
|
| Part A: Cohort 2 (5 to <18 Years of Age) | Experimental | Participants 5 to <18 years of age will receive a single IM injection of mRNA-1345 on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mRNA-1345 | Biological | Sterile liquid for injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) | Up to 7 days postinjection | |
| Part A: Number of Participants with Unsolicited Adverse Events (AEs) | Up to 28 days postinjection | |
| Part A: Number of Participants With Medically Attended AEs (MAAEs) | Day 1 through end of study (EOS; Month 6) | |
| Part A: Number of Participants With Adverse Events of Special Interest (AESIs) | Day 1 through EOS (Month 6) | |
| Part A: Number of Participants With Serious Adverse Events (SAEs) | Day 1 through EOS (Month 6) | |
| Part A: Number of Participants With AEs Leading to Discontinuation | Day 1 through EOS (Month 6) | |
| Part B: Number of participants With Respiratory syncytial virus-Respiratory tract disease (RSV-RTD), Respiratory syncytial virus- Lower Respiratory tract disease (RSV-LRTD), Severe RSV-LRTD, Very Severe RSV-LRTD and RSV Hospitalization | Day 1 through EOS (Month 6) |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Geometric Mean Titer (GMT) of Serum RSV Neutralizing Antibody | Day 1, Day 29, and Month 6 | |
| Part A: Geometric Mean Concentration (GMC) of Serum RSV Prefusion F Binding Antibody | Day 1, Day 29, and Month 6 |
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Key Inclusion Criteria:
Part A Cohort 1:
Cohort 2:
Part B: Cohort 1 Re-enrollment
Participants are eligible to be included in the study only if all of the following criteria apply:
Key Exclusion Criteria (All Cohorts):
Part B: Cohort 1 Re-enrollment
1. Participant is currently enrolled in another interventional clinical study.
Note: Other protocol-defined inclusion and exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Velocity Clinical Research, Phoenix | Phoenix | Arizona | 85006 | United States | ||
| Headlands Research - Scottsdale |
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| Placebo | Biological | 0.9% sodium chloride (normal saline) injection |
|
| Part A: Geometric Mean Fold Rise (GMFR) of Postbaseline/Baseline Neutralizing Antibody Titers and Binding Antibody Concentrations | Baseline to Day 29 and Month 6 |
| Part A: Number of Participants With Seroresponse in RSV Neutralizing Antibody | Seroresponse is defined as a postinjection titer >4-fold-rise if Baseline is >lower limit of quantification (LLOQ) or >4 × LLOQ if Baseline titer is \ | Baseline to Day 29 and Month 6 |
| Part B: Number of Participants With AESIs | Day 1 through EOS (Month 6) |
| Part B: Number of Participants With SAEs | Day 1 through EOS (Month 6) |
| Scottsdale |
| Arizona |
| 85260 |
| United States |
| Velocity Clinical Research - Banning | Banning | California | 92220 | United States |
| ASCADA Research, LLC - Family Medicine | Fullerton | California | 92835 | United States |
| Ark Clinical Research | Long Beach | California | 90815 | United States |
| Peninsula Research Associates (PRA) | Rolling Hills Estates | California | 90274 | United States |
| D&H Doral Research Center, LLC | Doral | Florida | 33122 | United States |
| Kissimmee Clinical Research | Kissimmee | Florida | 34741 | United States |
| Accel Clinical | Largo | Florida | 33777 | United States |
| Med-Care Research | Miami | Florida | 33125 | United States |
| Accel Research Sites - Nona Pediatric Center | Orlando | Florida | 32829 | United States |
| SEC Clinical Research | Pensacola | Florida | 32501 | United States |
| D&H Tamarac Research Center | Tamarac | Florida | 33321 | United States |
| Javara, Inc. | Fayetteville | Georgia | 30214 | United States |
| Velocity Clinical Research-Primary Pediatrics, Macon | Macon | Georgia | 31210 | United States |
| CenExel iResearch, LLC | Savannah | Georgia | 31405 | United States |
| Clinical Research Prime | Idaho Falls | Idaho | 83404 | United States |
| Velocity Clinical Research - Boise | Meridian | Idaho | 83642 | United States |
| Alliance for Multispeciality Research, LLC | El Dorado | Kansas | 67042 | United States |
| Velocity Clinical Research-Kansas City | Overland Park | Kansas | 66210 | United States |
| Velocity Clinical Research - Lafayette | Lafayette | Louisiana | 70508 | United States |
| Velocity Clinical Research Metairie | Metairie | Louisiana | 70006 | United States |
| Great Lakes Research Institute | Southfield | Michigan | 48075 | United States |
| Pediatric & Adolescent Center | Southgate | Michigan | 48195-1896 | United States |
| Clinical Research Institute | Minneapolis | Minnesota | 55402 | United States |
| Velocity Clinical Research, Gulfport | Gulfport | Mississippi | 39503 | United States |
| Velocity Clinical Research- Albuquerque | Albuquerque | New Mexico | 87107 | United States |
| Velocity Clinical Research-Binghamton | Binghamton | New York | 13905 | United States |
| University of Rochester Medical Center (URMC) - Golisano Children's Hospital (GCH) | Rochester | New York | 14620 | United States |
| Senders Pediatrics | South Euclid | Ohio | 44121 | United States |
| The Children's Hospital of Philadelphia - Pediatrics | Philadelphia | Pennsylvania | 19104-4318 | United States |
| DM Clinical Research - Philadelphia | Philadelphia | Pennsylvania | 19107 | United States |
| Velocity Clinical Research - Providence | Providence | Rhode Island | 02886 | United States |
| Coastal Pediatric Research | Charleston | South Carolina | 29414 | United States |
| Tribe Clinical Research | Simpsonville | South Carolina | 29680 | United States |
| Elligo Clinical Research Center | Austin | Texas | 78704 | United States |
| REX Clinical Trials, LLC | Beaumont | Texas | 77701 | United States |
| Javara Inc (Conroe) | Conroe | Texas | 77384 | United States |
| West Houston Clinical Research Service | Houston | Texas | 77055 | United States |
| DM Clinical Research - CyFair | Houston | Texas | 77065 | United States |
| Village Pediatrics | Plano | Texas | 75024 | United States |
| Javara Inc/Texas Health Care, PLLC d/b/a/ Privia Medical Group-North Texas | Stephenville | Texas | 76401 | United States |
| Victoria Clinical Research Group | Victoria | Texas | 77901 | United States |
| Velocity Clinical Research - Salt Lake City | West Jordan | Utah | 84088 | United States |
| PI-Coor Clinical Research, LLC | Annandale | Virginia | 22003 | United States |
| Clinical Research Partners | Richmond | Virginia | 23226 | United States |
| National Clinical Research, Inc. | Richmond | Virginia | 23294 | United States |
| CEVAXIN Chorrera | La Chorrera | 07066 | Panama |
| CEVAXIN Avenida Mexico | Panama City | 07093 | Panama |
| CEVAXIN 24 de Diciembre | Panama City | 07114 | Panama |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 11, 2026 | Jul 8, 2026 | 8 |
| 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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