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The main purpose of the study is to evaluate the safety, reactogenicity, and the humoral immunogenicity of mRNA-1010 and comparator influenza vaccines against homologous influenza A and B strains at Day 29.
The study consists of 3 parts. Part A of the study was conducted for the 2022-23 influenza season. Part B of the study was conducted in 2023-24 influenza season. Part C of the study will be conducted in 2024-25 influenza season.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parts A and B - Arm 1: mRNA-1010 (Age Group 18-50 years) | Experimental | Participants will receive a single dose of mRNA-1010 by intramuscular (IM) injection on Day 1. |
|
| Parts A and B - Arm 2: Egg-based Quadrivalent Influenza Vaccine (Age Group 18-50 years) | Active Comparator | Participants will receive a single dose of egg-based quadrivalent influenza vaccine by IM injection on Day 1. |
|
| Parts A and B - Arm 3: Adjuvanted Quadrivalent Influenza Vaccine (Age Group 65-80 years) | Active Comparator | Participants will receive a single dose of adjuvanted quadrivalent influenza vaccine by IM injection on Day 1. |
|
| Parts A and B - Arm 4: Inactivated Influenza Vaccine (Age Group 65-80 years) | Active Comparator | Participants will receive a single dose of inactivated influenza vaccine by IM injection on Day 1. |
|
| Parts A and B - Arm 5: mRNA-1010 (Age Group 65-80 years) | Experimental | Participants will receive a single dose of mRNA-1010 by IM injection on Day 1. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mRNA-1010 | Biological | Sterile liquid for injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Parts A, B, and C: Number of Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) | Up to Day 7 (7 days after vaccination) | |
| Parts A, B, and C: Number of Unsolicited Adverse Events (AEs) | Up to Day 28 (28 days after vaccination) | |
| Parts A, B, and C: Number of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), Medically Attended Adverse Events (MAAEs), and AEs Leading to Discontinuation | Day 1 through Day 181 | |
| Parts A, B, and C: Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutinin Inhibition (HAI) Assay | Day 29 | |
| Part C: GMT of Anti-Respiratory Syncytial Virus (RSV) Antibodies at Day 29, as Measured by Microneutralization Assay for RSV A and B | Day 29 | |
| Parts A, B, and C: Geometric Mean Fold Rise (GMFR) of Anti-HA Antibodies at Day 29, as Measured by HAI Assay | Baseline, Day 29 | |
| Part C: GMFR of Anti-RSV Antibodies at Day 29, as Measured by Microneutralization Assay | Baseline, Day 29 | |
| Parts A, B, and C: Percentage of Participants with Seroresponse at Day 29, as Measured by HAI Assay | Seroresponse is defined as a Day 29 titer > 1:40 if baseline is < 1:10 or a minimum 4-fold rise if baseline is >1:10 in anti-HA antibodies measured by HAI assay. | Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Parts A and B: GMT of Anti-HA Antibodies at Days 121 and 181, as Measured by HAI Assay or Microneutralization Assay | Days 121 and 181 | |
| Part C: GMT of Anti-HA Antibodies at Days 57, 121, and 181, as Measured by HAI Assay or Microneutralization Assay | Days 57, 121, and 181 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University in St. Louis | St Louis | Missouri | 63110 | United States |
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The study design for Part A and Prt C is randomized and Part B is non-randomized.
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|
| Part C - Arm 1: mRNA-1010 and mRNA-1345 (Age Group 18-50 years) | Experimental | Participants will receive one dose of mRNA-1010 concomitantly injected with one dose of mRNA-1345 in the contralateral arm at Day 1. |
|
| Part C - Arm 2: mRNA-1010 and mRNA-1345 (Age Group 18-50 years) | Experimental | Participants will receive one dose of mRNA-1010 at Day 1 followed by one dose of mRNA-1345 in the contralateral arm at Day 29. |
|
| Part C - Arm 3: mRNA-1045 (Age Group 18-50 years) | Experimental | Participants will receive a single dose of mRNA-1045 by IM injection on Day 1. |
|
| Egg-based Quadrivalent Influenza Vaccine | Biological | Sterile suspension for injection |
|
|
| Adjuvanted Quadrivalent Influenza Vaccine | Biological | Sterile injectable emulsion |
|
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| Inactivated Influenza Vaccine | Biological | Sterile suspension for injection |
|
|
| mRNA-1345 | Biological | Sterile liquid for injection |
|
| mRNA-1045 | Biological | Sterile liquid for injection |
|
| Part C: Percentage of Participants with Seroresponse at Day 29, as Measured by RSV Neutralization Assay | Seroresponse is defined as post-baseline titer ≥4-fold if baseline is ≥LLOQ or ≥4×LLOQ if baseline titer is \ | Day 29 |
| Parts A and B: GMFR of Anti-HA Antibodies at Days 121 and 181, as Measured by HAI Assay or MN Assay | Baseline, Days 121 and 181 |
| Part C: GMFR of Anti-HA Antibodies at Days 57, 121, and 181, as Measured by HAI Assay or MN Assay | Baseline, Days 57, 121, and 181 |
| Part C: Percentage of Participants with Seroresponse at Days 57, 121, and 181, as Measured by HAI Assay | Seroresponse is defined as a Day 57, 121, or 181 titer > 1:40 if baseline is < 1:10 or a minimum 4-fold rise if baseline is >1:10 in anti-HA antibodies measured by HAI assay. | Days 57, 121, and 181 |
| Part C: Percentage of Participants with Seroresponse at Days 57, 121, and 181, as Measured by RSV Neutralization Assay | Seroresponse is defined as post-baseline titer ≥4-fold if baseline is ≥LLOQ or ≥4×LLOQ if baseline titer is \ | Days 57, 121, and 181 |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000722747 | mRNA-1010 influenza vaccine |
| C510903 | fluarix |
| C478243 | fluad vaccine |
| D007252 | Influenza Vaccines |
| C000722749 | mRNA-1345 respiratory syncytial virus vaccine |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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