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New mRNA RSV vaccine shows promise for older adults in phase 3 trial

NCT ID NCT05330975

Vaccine Sponsor: ModernaTX, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 study tested an mRNA vaccine called mRNA-1345 to protect against respiratory syncytial virus (RSV) in adults aged 50 and older. Over 3,300 participants received the vaccine alone, with a flu shot, or with a COVID-19 booster. The trial also looked at a booster dose one year later. Researchers checked for side effects and measured immune responses to see if the vaccine is safe and works well when given with other vaccines.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
mRNA-1345 (an mRNA vaccine targeting RSV)
What this could lead to
If successful, this could provide a safe and effective RSV vaccine for older adults, potentially reducing severe respiratory illness and hospitalizations.
What could go wrong
This is a phase 3 trial, but results are not yet published. The vaccine may cause side effects or not work as well when given with other vaccines. Long-term safety and effectiveness are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

3,317 people

The number who actually took part.

Started

Apr 2022

Finished

Nov 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: Parts A and B both: * 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. Key Exclusion Criteria: Part A: * 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. Other inclusion and/or exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

viral infectious disease respiratory syncytial virus infectious disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Respiratory syncytial virus

Contacts and locations

Locations

  • Acclaim Clinical Research

    San Diego, California, 92120, United States

  • Ark Clinical Research

    Long Beach, California, 90806, United States

  • Ark Clinical Research

    Tustin, California, 92780, United States

  • Be Well Clinical Studies, LLC

    Lincoln, Nebraska, 68516, United States

  • Benchmark Research - Austin - HyperCore - PPDS

    Austin, Texas, 78705, United States

  • CCT Research at Springville Dermatology

    Springville, Utah, 84663, United States

  • CHEAR Center LLC - ClinEdge - PPDS

    The Bronx, New York, 10455-3908, United States

  • Central Research Associates Inc

    Birmingham, Alabama, 35205, United States

  • Central Valley Research, LLC

    Modesto, California, 95350, United States

  • Chase Medical Research LLC

    Waterbury, Connecticut, 06708, United States

  • Clinical Research Center of Nevada - ERN - PPDS

    Las Vegas, Nevada, 89106, United States

  • Clinical Research Institute, Inc - CRN - PPDS

    Minneapolis, Minnesota, 55402, United States

  • Clinical Trials of SWLA, LLC

    Lake Charles, Louisiana, 70601, United States

  • Cope Family Medicine - Ogden Clinic

    Bountiful, Utah, 84010-4862, United States

  • Del Sol Research Management - Clinedge - PPDS

    Tucson, Arizona, 85715, United States

  • Dolphin Medical Research

    Doral, Florida, 33172, United States

  • East-West Medical Research Institute

    Honolulu, Hawaii, 96814, United States

  • Empire Clinical Research

    Pomona, California, 91786, United States

  • Floridian Clinical Research - ClinEdge - PPDS

    Miami Lakes, Florida, 33016, United States

  • Georgia Clinic / CCT Research

    Norcross, Georgia, 30092-4544, United States

  • IMA Medical Research, PC.

    New York, New York, 10036-4103, United States

  • Indago Research and Health Center

    Hialeah, Florida, 33012, United States

  • Javara Inc./Privia Medical Group INC

    Forest, Virginia, 24551, United States

  • Javara Research Inc. - Charlotte - Javara - PPDS

    Charlotte, North Carolina, 28210, United States

  • Lifeline Primary Care / CCT Research

    Lilburn, Georgia, 30047-2832, United States

  • Long Beach Clinical Trials, LLC (Site 1)

    Long Beach, California, 90806, United States

  • Long Beach Clinical Trials, LLC (Site 2)

    Long Beach, California, 90806, United States

  • M3 Wake Research, Inc - M3 WR - ERN - PPDS

    Raleigh, North Carolina, 27612, United States

  • Medical Center For Clinical Research - M3 WR - ERN - PPDS

    San Diego, California, 92120, United States

  • Meridian Clinical Research

    Norfolk, Nebraska, 68701, United States

  • Meridian Clinical Research (Baton Rouge-Louisiana) - Platinum - PPDS

    Baton Rouge, Louisiana, 70809, United States

  • Meridian Clinical Research (Endwell-New York) - Platinum - PPDS

    Endwell, New York, 13760, United States

  • Meridian Clinical Research (Grand Island) - Platinum - PPDS

    Grand Island, Nebraska, 68803, United States

  • Meridian Clinical Research (Omaha-Nebraska) - Platinum - PPDS

    Omaha, Nebraska, 68134, United States

  • Meridian Clinical Research (Rockville Maryland) - Platinum - PPDS

    Rockville, Maryland, 20854-2957, United States

  • Meridian Clinical Research (Savannah Georgia) - Platinum - PPDS

    Savannah, Georgia, 31406, United States

  • Meridian Clinical Research (Sioux City - Iowa)

    Sioux City, Iowa, 51106, United States

  • Meridian Clinical Research - Cincinnati - Platinum - PPDS

    Springdale, Ohio, 45246, United States

  • Meridian Clinical Research - Family Practice Ports - Portsmouth - Platinum - PPDS

    Portsmouth, Virginia, 23703, United States

  • Meridian Clinical Research, LLC (Lincoln Nebraska) - Platinum - PPDS

    Lincoln, Nebraska, 68510, United States

  • Meridian Clinical Research, LLC (Overland Park, Kansas) - Platinum - PPDS

    Overland Park, Kansas, 66210-1863, United States

  • Midwest Regional Health Services - CCT Research

    Omaha, Nebraska, 68144, United States

  • Milton Haber, M.D.

    Laredo, Texas, 78041, United States

  • New Phase Research & Development

    Knoxville, Tennessee, 37909, United States

  • Paragon Rx Clinical, Inc

    Garden Grove, California, 92703-1811, United States

  • Revival Research Corporation - Clinedge - PPDS

    Doral, Florida, 33122, United States

  • Santa Rosa Medical Centers of Nevada - CCT Research

    Las Vegas, Nevada, 89119-5483, United States

  • Sun Research Institute

    San Antonio, Texas, 78215-1922, United States

  • Suncoast Research Associates LLC - ERN - PPDS

    Miami, Florida, 33173, United States

  • Suncoast Research Group LLC - ERN-PPDS

    Miami, Florida, 33135, United States

  • Tekton Research

    Moore, Oklahoma, 73160-1386, United States

  • Tekton Research - Beaumont - Platinum - PPDS

    Beaumont, Texas, 77706, United States

  • Tekton Research - Georgia - Platinum - PPDS

    Chamblee, Georgia, 30341, United States

  • Teradan Clinical Trials

    Brandon, Florida, 33511-4925, United States

  • Trial Management Associates LLC - ERN - PPDS

    Myrtle Beach, South Carolina, 29572-4612, United States

  • Velocity Clinical Research - Anderson - ERN - PPDS

    Anderson, South Carolina, 29621, United States

  • Velocity Clinical Research - Cleveland - ERN - PPDS

    Cleveland, Ohio, 44122, United States

  • Velocity Clinical Research - Greenville - ERN - PPDS

    Greenville, South Carolina, 29615, United States

  • Velocity Clinical Research - Panorama City

    Panorama City, California, 91402-3022, United States

  • Velocity Clinical Research - Spartanburg - ERN - PPDS

    Spartanburg, South Carolina, 29303-4225, United States

  • Westside Center for Clinical Research - ERN - PPDS

    Jacksonville, Florida, 32205, United States

  • Zenos Clinical Research

    Dallas, Texas, 75230, United States

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Other studies related to the condition(s) this trial covers.