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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-002138-15 | EudraCT Number |
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The primary goal of this study is to evaluate the safety and reactogenicity of multi-component vaccines mRNA-1045 (Influenza and RSV) and mRNA-1230 (influenza, RSV, and SARS-CoV-2) compared with mRNA-1010 (influenza), mRNA-1345 (RSV), and mRNA-1273.214 (SARS-CoV-2) vaccines in healthy older participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mRNA-1010 | Experimental | Participants will receive a dose of mRNA-1010 by intramuscular (IM) injection on Day 1. |
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| mRNA-1345 | Experimental | Participants will receive a dose of mRNA-1345 by IM injection on Day 1. |
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| mRNA-1273.214 | Experimental | Participants will receive a dose of mRNA-1273.214 by IM injection on Day 1. |
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| mRNA-1045 Dose Level A | Experimental | Participants will receive mRNA-1045 at Dose Level A by IM injection on Day 1. |
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| mRNA-1045 Dose Level B | Experimental | Participants will receive mRNA-1045 at Dose Level B by IM injection on Day 1. |
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| mRNA-1045 Dose Level C | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mRNA-1010 | Biological | Sterile liquid for injection |
| |
| mRNA-1345 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) | Up to Day 8 (7 days post vaccination) | |
| Number of Participants with Unsolicited Adverse Events (AEs) | Up to Day 29 (28 days post vaccination) | |
| Number of Participants with Medically-Attended AEs (MAAEs) | Day 1 through Day 361 | |
| Number of Participants with Adverse Events of Special Interest (AESIs) | Day 1 through Day 361 | |
| Number of Participants with Serious Adverse Events (SAEs) | Day 1 through Day 361 | |
| Number of Participants with AEs Leading to Discontinuation | Day 1 through Day 361 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Geometric Mean Titer (GMT) as Measured by Hemagglutination Inhibition (HAI) Assay at Day 29 | Baseline (Day 1), Day 29 | |
| Change From Baseline in GMT as Measured by Pseudovirus Neutralization Assay (PsVNA) (or Binding Antibody Assay) at Day 29 |
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Inclusion Criteria:
Exclusion Criteria:
Note: Other inclusion and exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Accel Research Sites | DeLand | Florida | 32720 | United States | ||
| Research Centers of America (cenexel) |
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All participants will be unblinded at Day 29 (1 month following study injection) to seek immunization with licensed influenza and/or SARS-CoV-2 vaccines, outside of the study, per local standard of care.
Participants will receive mRNA-1045 at Dose Level C by IM injection on Day 1.
|
| mRNA-1230 Dose Level A | Experimental | Participants will receive mRNA-1230 at Dose Level A by IM injection on Day 1. |
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| mRNA-1230 Dose Level B | Experimental | Participants will receive mRNA-1230 at Dose Level B by IM injection on Day 1. |
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| mRNA-1230 Dose Level C | Experimental | Participants will receive mRNA-1230 at Dose Level C by IM injection on Day 1. |
|
| Biological |
Sterile liquid for injection |
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| mRNA-1273.214 | Biological | Sterile liquid for injection |
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| mRNA-1045 | Biological | Formulation for injection |
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| mRNA-1230 | Biological | Formulation for injection |
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| Baseline (Day 1), Day 29 |
| Change From Baseline in GMT as Measured by Microneutralization Assay at Day 29 | Baseline (Day 1), Day 29 |
| Change From Baseline in Geometric Mean Fold-Rise (GMFR) as Measured by HAI Assay at Day 29 | Baseline (Day 1), Day 29 |
| Change From Baseline in GMFR as Measured by PsVNA (or Binding Antibody Assay) at Day 29 | Baseline (Day 1), Day 29 |
| Change From Baseline in GMFR as Measured by Microneutralization Assay at Day 29 | Baseline (Day 1), Day 29 |
| Influenza: Percentage of Participants with Seroconversion as Measured by HAI Assay | Seroconversion is defined as a Day 29 titer ≥1:40 if baseline is <1:10 or a 4-fold or greater rise if baseline is ≥1:10 in anti-HA antibodies measured by HAI assay. | Baseline (Day 1) to Day 29 |
| SARS-CoV-2: Percentage of Participants with Seroresponse as Measured by PsVNA (or Binding Antibody Assay) | Seroresponse is defined as a Day 29 titer ≥4-fold if baseline is ≥lower limit of quantification (LLOQ) or ≥4*LLOQ if baseline titer is \ | Baseline (Day 1) to Day 29 |
| RSV: Percentage of Participants with Seroresponse as Measured by RSV Neutralization Assay | Seroresponse is defined as a Day 29 titer ≥4-fold if baseline is ≥LLOQ or ≥4*LLOQ if baseline titer is \ | Baseline (Day 1) to Day 29 |
| Hollywood |
| Florida |
| 33024 |
| United States |
| Accel Research Sites | St. Petersburg | Florida | 33709 | United States |
| Atlanta Center for Medical Research - Family Medicine | Atlanta | Georgia | 30331 | United States |
| Centricity Research | Columbus | Georgia | 31904 | United States |
| Cenexel IRA (iResearch Atlanta) | Decatur | Georgia | 30030 | United States |
| Optimal Research | Peoria | Illinois | 61614 | United States |
| DM Clinical Research | Southfield | Michigan | 48076 | United States |
| Lucas Research, Inc. (Diabetes & Endocrinology Consultants PC) | Morehead City | North Carolina | 28557 | United States |
| Trial Management Associates | Wilmington | North Carolina | 28403 | United States |
| Velocity Clinical Research | Anderson | South Carolina | 29621 | United States |
| Trial Management Associates | Myrtle Beach | South Carolina | 29572 | United States |
| DM Clinical Research | Houston | Texas | 77081 | United States |
| DM Clinical Research | Sugar Land | Texas | 77478 | United States |
| Paratus Clinical Research Western Sydney | Blacktown | New South Wales | 2148 | Australia |
| Paratus Clinical Kanwal | Kanwal | New South Wales | 2259 | Australia |
| Paratus Clinical Research Brisbane | Albion | Queensland | 4010 | Australia |
| Nucleus Network Brisbane Clinic - Centre For Clinical Studies | Herston | Queensland | 4006 | Australia |
| University of the Sunshine Coast | South Brisbane | Queensland | 4101 | Australia |
| AusTrials Taringa | Taringa | Queensland | QLD 4068 | Australia |
| Emeritus Research | Camberwell | Victoria | 3124 | Australia |
| Newcastle University - Institute of Cellular Medicine (ICM) | Newcastle | England | NE2 4HH | United Kingdom |
| Nottingham University Hospitals NHS Trust - Queen's Medical Centre (QMC) Campus | Nottingham | Nottinghamshire | NG7 2UH | United Kingdom |
| University of Oxford | Oxford | Oxfordshire | OX3 7LJ | United Kingdom |
| Bristol Royal Hospital for Children | Bristol | BS2 8BJ | United Kingdom |
| Royal Devon & Exeter Hospital | Exeter | EX25DW | United Kingdom |
| Chelsea and Westminster Hospital | London | SW10 9NH | United Kingdom |
| St George's Healthcare NHS Trust - University of London - Th | London | SW17 0RE | United Kingdom |
| National Hospital for Neurology and Neurosurgery | London | WC1N 3GB | United Kingdom |
| Southampton General Hospital | Southampton | SO16 6YD | United Kingdom |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D018352 | Coronavirus Infections |
| D014777 | Virus Diseases |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D012140 | Respiratory Tract Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C000722747 | mRNA-1010 influenza vaccine |
| C000722749 | mRNA-1345 respiratory syncytial virus vaccine |
| C000722752 | mRNA-1273.214 COVID-19 vaccine |
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