A Study of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥50 Years of Age
NCT ID: NCT05330975
Last Updated: 2025-12-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
3317 participants
INTERVENTIONAL
2022-04-01
2024-11-08
Brief Summary
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The main purposes of Part B of this study are to evaluate the safety, tolerability, and immunogenicity of mRNA-1345 coadministered with mRNA-1273.214; to evaluate the effect of coadministered mRNA-1273.214 on the immune response to RSV-A; and to evaluate the effect of coadministered RSV vaccine on the immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
The main purposes of Part C (single arm, open-label) of this study are to evaluate the safety and tolerability of a booster dose (BD) of mRNA-1345 administered at 1 Year following a primary dose; to evaluate the immune response to RSV-A of a BD of mRNA 1345 administered at 1 Year following a primary dose; and to evaluate the immune response to RSV-B of a BD of mRNA-1345 administered at 1 Year following a primary dose.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Part A: mRNA-1345 + Placebo
Single injection of mRNA-1345 and placebo, administered intramuscularly (IM), one in each arm on Day 1.
Placebo
0.9% sodium chloride (normal saline) injection
mRNA-1345
Sterile liquid for injection
Part A: mRNA-1345 + Afluria® Quadrivalent
Single injection of mRNA-1345 and Afluria® quadrivalent, administered IM, one in each arm on Day 1.
mRNA-1345
Sterile liquid for injection
Afluria® Quadrivalent
single-dose, pre-filled syringe for injection
Part A: Afluria® Quadrivalent + Placebo
Single injection of Afluria® quadrivalent and placebo, administered IM, one in each arm on Day 1.
Placebo
0.9% sodium chloride (normal saline) injection
Afluria® Quadrivalent
single-dose, pre-filled syringe for injection
Part B: mRNA-1345 + Placebo
Single injection of mRNA-1345 and placebo, administered IM, one in each arm on Day 1. An additional injection of mRNA-1273.214, administered on Day 29.
Placebo
0.9% sodium chloride (normal saline) injection
mRNA-1345
Sterile liquid for injection
mRNA-1273.214
Sterile liquid for injection
Part B: mRNA-1345 + mRNA-1273.214
Single injection of mRNA-1345 and mRNA-1273.214, administered IM, one in each arm on Day 1. An additional injection of placebo administered on Day 29.
Placebo
0.9% sodium chloride (normal saline) injection
mRNA-1345
Sterile liquid for injection
mRNA-1273.214
Sterile liquid for injection
Part B: mRNA-1273.214 + Placebo
Single injection of mRNA-1273.214 and placebo, administered IM, one in each arm on Day 1. An additional injection of placebo administered on Day 29.
Placebo
0.9% sodium chloride (normal saline) injection
mRNA-1273.214
Sterile liquid for injection
Part C: mRNA-1345
Single injection of mRNA-1345 administered IM on BD Day 1.
mRNA-1345
Sterile liquid for injection
Interventions
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Placebo
0.9% sodium chloride (normal saline) injection
mRNA-1345
Sterile liquid for injection
Afluria® Quadrivalent
single-dose, pre-filled syringe for injection
mRNA-1273.214
Sterile liquid for injection
Eligibility Criteria
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Inclusion Criteria
* Adults ≥50 years of age on the day of the Randomization Visit (Day 1) who are primarily responsible for self-care and activities of daily living. Participants may have one or more chronic medical diagnoses, but should be medically stable as assessed by: Absence of changes in medical therapy within 1 month due to treatment failure or toxicity; Absence of medical events qualifying as SAEs within 1 month of the planned vaccination on Day 1; and absence of known, current, and life-limiting diagnoses which, in the opinion of the investigator, would make completion of the protocol unlikely.
* Able to comply with study requirements, including access to transportation for study visits.
Part B only:
* Fully vaccinated for COVID-19 with an approved primary series according to the locally authorized or approved regimen. If the most recent COVID-19 vaccine was part of a primary series, it must be ≥ 150 days before (or less per local guidance) Day 1. If the most recent COVID-19 vaccine was a booster dose, it must be ≥ 120 days before (or less per local guidance) Day 1.
Part C:
* Participants at Part C study sites who have been enrolled in Part B (Groups 4 and 5) of this study; have immunogenicity blood sampling at Part B baseline and Day 29; completed the Day 211/end-of-study visits for Part B; were included in the per-protocol (PP) set; and received 1 dose of mRNA-1345 at least 12 months (but no later than 15 months) prior to the time of enrollment.
* Able to comply with study requirements, including access to transportation for study visits.
Exclusion Criteria
* Participant has received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days prior to study injections (Day 1) or plans to receive a vaccine authorized or approved by a local health agency within 28 days after the study injections.
* Prior participation in research involving receipt of any investigational product (drug/biologic/device including any investigational RSV product) within 45 days before the planned date of the Day 1 study injection.
* Participant has received a seasonal influenza vaccine or any other investigational influenza vaccine ≤180 days prior to the Randomization Visit (Day 1).
* History of a serious reaction to any prior vaccination, or Guillain-Barré syndrome within 6 weeks of any prior influenza immunization.
* Participated in an interventional clinical study within 28 days prior to the Screening Visit based on the medical history interview or plans to do so while participating in this study.
Part B:
* Participant has received or plans to receive any vaccine authorized or approved by a local health agency ≤ 28 days prior to study injections (Day 1) or plans to receive a vaccine authorized or approved by a local health agency within 28 days after the study injections (with the exception of SARS-Cov-2 vaccination).
* Prior participation in research involving receipt of any investigational product (drug/biologic/device with the exception of RSV investigation products) within 45 days before the planned date of the Day 1 study injection.
* Prior receipt of any investigational/approved RSV product within 1 year of the Day 1 study injection.
* Has known history of SARS-CoV-2 infection within 90 days prior to enrollment.
Parts A and B both:
* Participant had significant exposure to someone with SARS-CoV-2 infection or COVID-19 in the past 10 days, as defined by the United States (US) Centers for Disease Control and Prevention (CDC) as a close contact of someone who has had COVID-19.
Part C:
* Participation in another interventional clinical research study where participant has received an investigational product (drug/biologic/device) within 6 months before the planned date of the BD Day 1 study injection. Any prior receipt of an investigational or approved vaccine against RSV, except as part of mRNA-1345 Study P302 Part B, is exclusionary.
* Participant has received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days prior to the study injection (BD Day 1) or plans to receive a vaccine authorized or approved by a local health agency within 28 days after the study injections.
* History of a serious reaction to any prior vaccination or Guillain-Barré syndrome 6 weeks after any prior influenza immunization.
50 Years
ALL
Yes
Sponsors
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ModernaTX, Inc.
INDUSTRY
Responsible Party
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Locations
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Central Research Associates Inc
Birmingham, Alabama, United States
Del Sol Research Management - Clinedge - PPDS
Tucson, Arizona, United States
Paragon Rx Clinical, Inc
Garden Grove, California, United States
Ark Clinical Research
Long Beach, California, United States
Long Beach Clinical Trials, LLC (Site 1)
Long Beach, California, United States
Long Beach Clinical Trials, LLC (Site 2)
Long Beach, California, United States
Central Valley Research, LLC
Modesto, California, United States
Velocity Clinical Research - Panorama City
Panorama City, California, United States
Empire Clinical Research
Pomona, California, United States
Acclaim Clinical Research
San Diego, California, United States
Medical Center For Clinical Research - M3 WR - ERN - PPDS
San Diego, California, United States
Ark Clinical Research
Tustin, California, United States
Chase Medical Research LLC
Waterbury, Connecticut, United States
Teradan Clinical Trials
Brandon, Florida, United States
Revival Research Corporation - Clinedge - PPDS
Doral, Florida, United States
Dolphin Medical Research
Doral, Florida, United States
Indago Research and Health Center
Hialeah, Florida, United States
Westside Center for Clinical Research - ERN - PPDS
Jacksonville, Florida, United States
Suncoast Research Group LLC - ERN-PPDS
Miami, Florida, United States
Suncoast Research Associates LLC - ERN - PPDS
Miami, Florida, United States
Floridian Clinical Research - ClinEdge - PPDS
Miami Lakes, Florida, United States
Tekton Research - Georgia - Platinum - PPDS
Chamblee, Georgia, United States
Lifeline Primary Care / CCT Research
Lilburn, Georgia, United States
Georgia Clinic / CCT Research
Norcross, Georgia, United States
Meridian Clinical Research (Savannah Georgia) - Platinum - PPDS
Savannah, Georgia, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States
Meridian Clinical Research (Sioux City - Iowa)
Sioux City, Iowa, United States
Meridian Clinical Research, LLC (Overland Park, Kansas) - Platinum - PPDS
Overland Park, Kansas, United States
Meridian Clinical Research (Baton Rouge-Louisiana) - Platinum - PPDS
Baton Rouge, Louisiana, United States
Clinical Trials of SWLA, LLC
Lake Charles, Louisiana, United States
Meridian Clinical Research (Rockville Maryland) - Platinum - PPDS
Rockville, Maryland, United States
Clinical Research Institute, Inc - CRN - PPDS
Minneapolis, Minnesota, United States
Meridian Clinical Research (Grand Island) - Platinum - PPDS
Grand Island, Nebraska, United States
Meridian Clinical Research, LLC (Lincoln Nebraska) - Platinum - PPDS
Lincoln, Nebraska, United States
Be Well Clinical Studies, LLC
Lincoln, Nebraska, United States
Meridian Clinical Research
Norfolk, Nebraska, United States
Meridian Clinical Research (Omaha-Nebraska) - Platinum - PPDS
Omaha, Nebraska, United States
Midwest Regional Health Services - CCT Research
Omaha, Nebraska, United States
Clinical Research Center of Nevada - ERN - PPDS
Las Vegas, Nevada, United States
Santa Rosa Medical Centers of Nevada - CCT Research
Las Vegas, Nevada, United States
Meridian Clinical Research (Endwell-New York) - Platinum - PPDS
Endwell, New York, United States
IMA Medical Research, PC.
New York, New York, United States
CHEAR Center LLC - ClinEdge - PPDS
The Bronx, New York, United States
Javara Research Inc. - Charlotte - Javara - PPDS
Charlotte, North Carolina, United States
M3 Wake Research, Inc - M3 WR - ERN - PPDS
Raleigh, North Carolina, United States
Velocity Clinical Research - Cleveland - ERN - PPDS
Cleveland, Ohio, United States
Meridian Clinical Research - Cincinnati - Platinum - PPDS
Springdale, Ohio, United States
Tekton Research
Moore, Oklahoma, United States
Velocity Clinical Research - Anderson - ERN - PPDS
Anderson, South Carolina, United States
Velocity Clinical Research - Greenville - ERN - PPDS
Greenville, South Carolina, United States
Trial Management Associates LLC - ERN - PPDS
Myrtle Beach, South Carolina, United States
Velocity Clinical Research - Spartanburg - ERN - PPDS
Spartanburg, South Carolina, United States
New Phase Research & Development
Knoxville, Tennessee, United States
Benchmark Research - Austin - HyperCore - PPDS
Austin, Texas, United States
Tekton Research - Beaumont - Platinum - PPDS
Beaumont, Texas, United States
Zenos Clinical Research
Dallas, Texas, United States
Milton Haber, M.D.
Laredo, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
Cope Family Medicine - Ogden Clinic
Bountiful, Utah, United States
CCT Research at Springville Dermatology
Springville, Utah, United States
Javara Inc./Privia Medical Group INC
Forest, Virginia, United States
Meridian Clinical Research - Family Practice Ports - Portsmouth - Platinum - PPDS
Portsmouth, Virginia, United States
Countries
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References
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Goswami J, Cardona JF, Caso J, Hsu DC, Simorellis AK, Wilson L, Dhar R, Wang X, Kapoor A, Collins A, Righi V, Lan L, Du J, Zhou H, Stoszek SK, Shaw CA, Reuter C, Wilson E, Das R. Safety, Tolerability, and Immunogenicity of Revaccination with mRNA-1345, an mRNA Vaccine Against RSV, Administered 12 Months Following a Primary Dose in Adults Aged >/=50 Years. Clin Infect Dis. 2025 Sep 23:ciaf515. doi: 10.1093/cid/ciaf515. Online ahead of print.
Goswami J, Cardona JF, Hsu DC, Simorellis AK, Wilson L, Dhar R, Tomassini JE, Wang X, Kapoor A, Collins A, Righi V, Lan L, Du J, Zhou H, Stoszek SK, Shaw CA, Reuter C, Wilson E, Miller JM, Das R; study investigators. Safety and immunogenicity of mRNA-1345 RSV vaccine coadministered with an influenza or COVID-19 vaccine in adults aged 50 years or older: an observer-blinded, placebo-controlled, randomised, phase 3 trial. Lancet Infect Dis. 2025 Apr;25(4):411-423. doi: 10.1016/S1473-3099(24)00589-9. Epub 2024 Nov 25.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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mRNA-1345-P302
Identifier Type: -
Identifier Source: org_study_id