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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-502022-41 | EudraCT Number | ||
| 2022-502022-41-00 | Other Identifier | EU CT Number |
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The purpose of this study is to assess the safety and immunogenicity of mRNA-1365, an mRNA vaccine targeting respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) and mRNA-1345, an mRNA vaccine targeting RSV, in participants aged 5 months to <24 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: mRNA-1345, Dose 1 (Age Group: 8 to <24 months) | Experimental | Participants will receive mRNA-1345 vaccine by intramuscular (IM) injection on Days 1, 57 and 113. |
|
| Part A: mRNA-1365, Dose 1 (Age Group: 8 to <24 months) | Experimental | Participants will receive mRNA-1365 vaccine by IM injection on Days 1, 57 and 113. |
|
| Part A: Placebo (Age Group: 8 to <24 months) | Placebo Comparator | Participants will receive mRNA-1345/ mRNA-1365 vaccine matching placebo by IM injection on Days 1, 57 and 113. In countries where applicable, participants may receive Nimenrix instead of placebo on Day 113. |
|
| Part B: mRNA-1345, Dose 2 (Age Group: 5 to <8 months) | Experimental | Participants will receive mRNA-1345 by IM injection on Days 1, 57 and 113. |
|
| Part B: mRNA-1365, Dose 2 (Age Group: 5 to <8 months) | Experimental | Participants will receive mRNA-1365 by IM injection on Days 1, 57 and 113. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mRNA-1345 | Biological | Sterile liquid for injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Main Study: Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) | Up to Day 120 (7 days after each injection) | |
| Main Study: Number of Participants with Unsolicited Adverse Events (AEs) | Up to Day 141 (28 days after each injection) | |
| Main Study: Number of Participants with Medically-Attended Adverse Events (MAAEs) | Day 1 through Day 730 | |
| Main Study: Number of Participants with Adverse Event of Special Interests (AESIs), Serious Adverse Events (SAEs) and Adverse Events Leading to Discontinuation | Day 1 through Day 730 | |
| Part B Extension: Number of Participants with MAAEs, AESIs and SAEs | Day 1 of the Extension to end of study (EoS) (up to 3 years) | |
| Part B Extension: Number of Participants with Lower Respiratory Tract Illness (LRTI), Severe LRTI, Very Severe LRTI, and Hospitalizations Associated with RSV or hMPV | Day 1 of the Extension to EoS (up to 3 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Main Study: Number of Participants with Respiratory tract Illness (RTI), LRTI, Severe LRTI, Very Severe LRTI, and Hospitalizations Associated with RSV or hMPV | Day 1 through Day 730 | |
| Main Study (Parts A and B): Geometric Mean Titer (GMT) of Serum RSV and hMPV Neutralizing Antibodies |
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Inclusion Criteria:
Exclusion Criteria:
Note: Other protocol-defined inclusion/exclusion criteria apply.
Inclusion Criteria:
Exclusion Criteria:
• For Part B Extension, there are no specific exclusion criteria.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Matrix Clinical Research | Los Angeles | California | 90057 | United States | ||
| Meridian Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39608233 | Derived | Amodio D, Angelidou A, Cotugno N, Sherman AC, Levy O, Palma P; IPVC 2023 Speakers' group. Biomarkers of vaccine safety and efficacy in vulnerable populations: Lessons from the fourth international precision vaccines conference. Vaccine. 2025 Jan 1;43(Pt 2):126477. doi: 10.1016/j.vaccine.2024.126477. Epub 2024 Nov 28. |
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Parts A and B are blinded, and Part C is open-label. Part B Extension is unblinded.
| Part B: mRNA-1345 Dose 1 (Age Group: 5 to <8 months) | Experimental | Participants will receive mRNA-1345 by IM injection on Days 1, 57 and 113. |
|
| Part B: mRNA-1365 Dose 1 (Age Group: 5 to <8 months) | Experimental | Participants will receive mRNA-1365 by IM injection on Days 1, 57 and 113. |
|
| Part B: Placebo (Age Group: 5 to <8 months) | Placebo Comparator | Participants will receive mRNA-1345/ mRNA-1365 vaccine matching placebo by IM injection on Days 1, 57 and 113. In countries where applicable, participants may receive Nimenrix instead of placebo on Day 113. |
|
| Part B Extension: mRNA-1345, Dose 2 (Age Group: 5 to <8 months) | No Intervention | Participants will have the option to re-enrol in the Part B extension period. |
| Part B Extension: mRNA-1365, Dose 2 (Age Group: 5 to <8 months) | No Intervention | Participants will have the option to re-enrol in the Part B extension period. |
| Part B Extension: mRNA-1345 Dose 1 (Age Group: 5 to <8 months) | No Intervention | Participants will have the option to re-enrol in the Part B extension period. |
| Part B Extension: mRNA-1365 Dose 1 (Age Group: 5 to <8 months) | No Intervention | Participants will have the option to re-enrol in the Part B extension period. |
| Part B Extension : Placebo (Age Group: 5 to <8 months) | No Intervention | Participants will have the option to re-enrol in the Part B extension period. |
| Part C: mRNA-1345 Dose 1 (Age Group 8 to <12 months exposed to nirsevimab) | Experimental | Participants who have been previously exposed to nirsevimab will receive mRNA 1345 by IM injection on Days 1, 57, and 113. |
|
| Part C: mRNA-1345 Dose 1 (Age Group 8 to <12 months not exposed to nirsevimab) | Experimental | Participants who have not been previously exposed to nirsevimab will receive mRNA 1345 by IM injection on Days 1, 57, and 113. |
|
| mRNA-1365 | Biological | Sterile liquid for injection |
|
| Placebo | Biological | 0.9% sodium chloride (normal saline) solution for injection |
|
| Nimenrix | Drug | Solution for injection |
|
| Baseline up to Month 12 |
| Main Study (Part C): GMT of Serum RSV Neutralizing Antibodies | Baseline up to Month 12 |
| Main Study (Parts A and B): Geometric Mean Concentration (GMC) of Serum RSV F- and hMPV F-Binding Antibodies | Baseline up to Month 12 |
| Main Study (Part C): GMC of Serum RSV F-Binding Antibodies | Baseline up to Month 12 |
| Main Study: Geometric Mean Fold-Rise (GMFR) of Postbaseline/baseline Neutralizing Antibody Titers and Binding Antibody | Month 12 |
| Main Study: Number of Participants with Vaccine-specific T-cell Responses Measured by Flow Cytometry | Baseline up to Month 12 |
| Part B Extension: Geometric Mean Titer (GMT) of Serum RSV and hMPV Neutralizing Antibodies | Day 1 of the Extension up to EoS (up to 3 years) |
| Part B Extension: Geometric Mean Concentration (GMC) of Serum RSV F- and hMPV F-Binding Antibodies | Day 1 of the Extension up to EoS (up to 3 years) |
| Part B Extension: Geometric Mean Fold-Rise (GMFR) of Postbaseline/baseline Neutralizing Antibody Titers and Binding Antibody | Day 1 of the Extension up to EoS (up to 3 years) |
| Part B Extension: Number of Participants with Vaccine-specific T-cell Responses Measured by Flow Cytometry | Day 1 of the Extension up to EoS (up to 3 years) |
| Washington D.C. |
| District of Columbia |
| 20016 |
| United States |
| DM Clinical Research- River Forest | Melrose Park | Illinois | 60160 | United States |
| MedPharmics - Platinum - PPDS | Lafayette | Louisiana | 70508 | United States |
| Duke Vaccine and Trials Unit | Durham | North Carolina | 27703 | United States |
| Velocity Clinical Research - Providence | Providence | Rhode Island | 02886 | United States |
| Palmetto Pediatrics, PA | North Charleston | South Carolina | 29406-9170 | United States |
| Vanderbilt Vaccine Research Program | Nashville | Tennessee | 37232 | United States |
| CyFair | Houston | Texas | 77065 | United States |
| Pediatric Associates | Houston | Texas | 77087 | United States |
| Village Pediatrics | Plano | Texas | 75024 | United States |
| Pediatric Center | Richmond | Texas | 77469 | United States |
| CEVAXIN David | David | Chiriquí Province | 0401 | Panama |
| CEVAXIN Chorrera | La Chorrera | Panamá Oeste Province | Panama |
| CEVAXIN Avenida Mexico | Panama City | 0801 | Panama |
| CEVAXIN 24 de Diciembre | Panama City | Panama |
| Norfolk and Norwich University Hospitals | Norwich | NR4 7UY | United Kingdom |
| ID | Term |
|---|---|
| C000722749 | mRNA-1345 respiratory syncytial virus vaccine |
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