Respiratory Syncytial VirusPhase 3NCT06067230
A Study to Investigate the Immunogenicity and Safety of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in High-risk Adults
A Phase 3 study testing mRNA-1345 in people with Respiratory Syncytial Virus, run by ModernaTX, Inc. at 44 sites in 4 countries.
Trial summary
The study is divided into 2 parts (Part A and Part B). Part A of the study will evaluate the safety and immune response to mRNA-1345 in high-risk adults aged ≥18 to <60 years. Part B of the study will evaluate the safety and immune response to mRNA-1345 in adults who received solid organ transplant (SOT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Syncytial Virus
- What is being tested?
- mRNA-1345
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,153 participants
- Where
- 44 sitesin 4 countries
- Study dates
- 6 Oct 2023to 24 Jul 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Part A:
- Adults ≥18 to <60 years of age at the time of consent who are primarily responsible for self-care and activities of daily living.
- Documented confirmation by a physician of the diagnosis of at least one of the following conditions:
- Coronary artery disease and/or congestive heart failure.
- Chronic lung disease (for example, including but not limited to chronic obstructive pulmonary disease or persistent asthma).
- Stable type 1 or type 2 diabetes mellitus controlled with at least 1 medication started 90 days or more prior to Day 1.
Show all 11Show fewer
- Part B:
- Adults ≥18 years of age at the time of consent who are primarily responsible for self-care and activities of daily living.
- Recipient of an SOT (kidney, liver, or lung transplant) ≥180 days prior to day of consent and receiving chronic immunosuppressive therapy for the prevention of allograft rejection.
- Parts A and B:
- Able to comply with study requirements.
Who cannot join
- Part A:
- Participation in an another clinical research trial where the participant has received an investigational product 180 days prior to Day 1. Participation in an RSV trial at any time prior to Day 1 is exclusionary.
- History of a diagnosis or condition, that, in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures.
- Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of the mRNA-1345 injection or any components of the mRNA-1345 injection.
- Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 180 days prior to Day 1.
- History of myocarditis, pericarditis, or myopericarditis.
Show all 12Show fewer
- Part B:
- Previous treatment with alemtuzumab or rituximab within 2 years prior to Day 1.
- Previous treatment with plasmapheresis within 30 days prior to Day 1.
- A history of complications of immunosuppression.
- A history of biopsy proven or clinically diagnosed rejection within 90 days prior to Day 1 or suspected active chronic rejection according to the Investigator's judgment.
- Note: Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
44 sites in 4 countries.
44 sites in 4 countries
United States32 sites
Excel Medical Clinical Trials DBA Flourish
Boca Raton, Florida, 33434
University of Chicago
Chicago, Illinois, 60637-1443
Benchmark Research - Covington - HyperCore - PPDS
Covington, Louisiana, 70433
Henry Ford Hospital
Detroit, Michigan, 48202-2608
Duke University Medical Center
Durham, North Carolina, 27710
Benchmark Research - Fort Worth - HyperCore - PPDS
Fort Worth, Texas, 76135-5283
Lenzmeier Family Medicine - CCT - PPDS
Glendale, Arizona, 85308-5093
Velocity Clinical Research - Hampton - PPDS
Hampton, Virginia, 23666-6262
Indago Research and Health Center
Hialeah, Florida, 33012-4170
CenExel RCA - Hollywood
Hollywood, Florida, 33024-2709
DM Clinical Research - Cyfair Clinical Research Center
Houston, Texas, 77065-5685
Snake River Research, PLLC
Idaho Falls, Idaho, 83404-7573
Critical Care, Pulmonary and Sleep Associates / CCT Research
Lakewood, Colorado, 80228
Velocity Clinical Research (Lincoln - Nebraska) - PPDS
Lincoln, Nebraska, 68510
Baptist Health Center for Clinical Research
Little Rock, Arkansas, 72205
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095-3075
Yale University School of Medicine
New Haven, Connecticut, 06510-2483
AES - DRS - Optimal Research Illinois - Peoria
Peoria, Illinois, 61614-4885
DM Clinical Research - Philadelphia - ERN - PPDS
Philadelphia, Pennsylvania, 19107-1530
Foothills Research Center - CCT - PPDS
Phoenix, Arizona, 85044-6097
University of Rochester - Rochester General Hospital - PPDS
Rochester, New York, 14621-3011
Velocity Clinical Research (Rockville - Maryland) - PPDS
Rockville, Maryland, 20854-2960
Benchmark Research - San Angelo - HyperCore - PPDS
San Angelo, Texas, 76904-7610
Artemis Institute For Clinical Research LLC - San Diego - Headlands - PPDS
San Diego, California, 92103-2209
DM Clinical Research - Southfield - ERN - PPDS
Southfield, Michigan, 48076-5412
Springville Dermatology - CCT - PPDS
Springville, Utah, 84663
Clinical Research Atlanta - Headlands - PPDS
Stockbridge, Georgia, 30281-9054
Centricity Research Suffolk Family Medicine
Suffolk, Virginia, 23435-3763
Velocity Clinical Research - Family Practice - Suffolk - PPDS
Suffolk, Virginia, 23435
Fiel Family & Sports Medicine - PC - CCT - PPDS
Tempe, Arizona, 85283-1528
Montefiore Medical Center - BRANY - PPDS
The Bronx, New York, 10467-2401
DM Clinical Research - ERN - PPDS
Tomball, Texas, 77375-6543
Canada6 sites
University of Alberta
Edmonton, Alberta, T6G 2B7
Canadian Center for Vaccinology
Halifax, Nova Scotia, L7 8XZ
OCT Research ULC (dba Okanagan Clinical Trials)
Kelowna, British Columbia, V1Y 1Z9
Diex Recherche - Québec - PPDS
Québec, G1V 4T3
Diex Recherche - Sherbrooke - PPDS
Sherbrooke, Quebec, J1L 0H8
Colchester Research Group
Truro, Nova Scotia, B2N 1L2
United Kingdom5 sites
Aberdeen Royal Infirmary - PPDS
Aberdeen, AB25 2ZD
Fylde Coast Clinical Research
Blackpool, Lancashire, FY3 7EN
Royal Devon and Exeter Hospital
Exeter, Devon, EX2 5DW
Liverpool School of Tropical Medicine
Liverpool, Merseyside, L7 8XZ
The Royal Free Hospital
London, NW3 2QG
About this study
Official title: A Phase 3 Study to Evaluate the Immunogenicity and Safety of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in High-Risk Adults
The study is divided into 2 parts (Part A and Part B). Part A of the study will evaluate the safety and immune response to mRNA-1345 in high-risk adults aged ≥18 to <60 years.
Part B of the study will evaluate the safety and immune response to mRNA-1345 in adults who received solid organ transplant (SOT).
- Conditions
- Respiratory Syncytial Virus
- Being tested
- mRNA-1345
- Keywords
- Viral Diseases, Messenger RNA, Moderna, mRNA-1345, Respiratory syncytial virus, Safety, Vaccines, Immunocompromised, Organ transplant
- Medical subject headings
- Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA-1345Biological
Sterile liquid for injection
| Study group | Role | What they receive |
|---|---|---|
| Part A: mRNA-1345 Dose 1 | Experimental | Single injection of mRNA-1345 administered intramuscularly (IM) on Day 1. Receives: Biological: mRNA-1345 |
| Part A: mRNA-1345 Dose 2 | Experimental | Single injection of mRNA-1345 administered IM on Day 1. Receives: Biological: mRNA-1345 |
| Part B: mRNA-1345 Dose 2 | Experimental | Two injections of mRNA-1345 administered IM on Day 1 and Day 57. Receives: Biological: mRNA-1345 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Measured: Day 1 through Day 7 (7 days post injection) for Part A and Day 1 through Day 64 (7 days post second injection) for Part B
Number of Participants with Unsolicited Adverse Events (AEs)
Measured: Day 1 through Day 28 (28 days post injection) for Part A and Day 1 through Day 84 (28 days post second injection) for Part B
Number of Participants With Medically Attended AEs (MAAEs)
Measured: Day 1 through Month 6 (for Part A) and Day 1 through Month 9 (for Part B)
Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and AEs Leading to Discontinuation
Measured: Day 1 through End of Study (Day 730)
Part A: Geometric Mean Titer (GMT) of Serum Respiratory Syncytial Virus Subtype A (RSV-A) and Respiratory Syncytial Virus Subtype B (RSV-B) Neutralizing Antibodies (Abs) at Day 29
Measured: Day 29
Part B: GMT of Serum RSV-A and RSV-B Neutralizing Abs at Day 85
Measured: Day 85
Secondary outcomes (21)
Part A: Seroresponse Rate (SRR) of RSV-A and RSV-B Neutralizing Abs on Day 29
Measured: Day 29
Part A: Geometric Mean Concentration (GMC) of Serum RSV Prefusion Conformation of the F Protein (Pre-F) Binding Abs
Measured: Up to End of Study (Day 730)
Part A: Geometric Mean Fold-Rise (GMFR) of Serum RSV Pre-F Binding Abs
Measured: Up to End of Study (Day 730)
Part A: SRR of Serum RSV Pre-F Binding Abs at Postbaseline/Baseline Levels
Measured: Baseline up to Day 730
Part A: Number of Participants with ≥2-Fold Increase in RSV Pre-F Binding Abs
Measured: Up to End of Study (Day 730)
Part A: GMT of Serum RSV-A and RSV-B Neutralizing Abs at Day 29
Measured: Day 29
Part A: GMT of Postinjection/Baseline Titers to RSV-A and RSV-B Neutralizing Abs
Measured: Baseline up to Day 730
Part A: GMFR of Postinjection/Baseline Titers to RSV-A and RSV-B Neutralizing Abs
Measured: Baseline up to Day 730
Part A: SRR of Serum RSV-A and RSV-B Neutralizing Abs
Measured: Up to End of Study (Day 730)
Part A: Number of Participants with ≥2-Fold Increase in RSV-A and RSV-B Neutralizing Abs Titers
Measured: Up to End of Study (Day 730)
Part B: GMT of Serum RSV-A and RSV-B Neutralizing Abs at Day 29
Measured: Day 29
Part B: SRR of Serum RSV-A and RSV-B Neutralizing Abs on Day 29
Measured: Day 29
Part B: SRR of Serum RSV-A and RSV-B Neutralizing Abs on Day 85
Measured: Day 85
Part B: GMT of Serum RSV-A and RSV-B Neutralizing Abs
Measured: Up to End of Study (Day 730)
Part B: GMFR of Serum RSV-A and RSV-B Neutralizing Abs
Measured: Up to End of Study (Day 730)
Part B: SRR of Serum RSV-A and RSV-B Neutralizing Abs at Postbaseline/Baseline Levels
Measured: Baseline up to Day 730
Part B: Number of Participants with ≥2-Fold Increase in RSV-A and RSV-B Neutralizing Abs
Measured: Up to End of Study (Day 730)
Part B: GMC of Serum RSV Pre-F Binding Abs
Measured: Up to End of Study (Day 730)
Part B: GMFR of Serum RSV Pre-F Binding Abs
Measured: Up to End of Study (Day 730)
Part B: SRR of Serum RSV Pre-F Binding Abs at Postbaseline/Baseline Levels
Measured: Baseline up to End of Study (Day 730)
Part B: Number of Participants with ≥2-Fold Increase in RSV Pre-F Binding Abs
Measured: Up to End of Study (Day 730)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start6 Oct 2023
- Primary completion24 Jul 2026
- Study completion24 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Respiratory Syncytial VirusStudies of the same condition, open and under way.
- More trials run by ModernaTX, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Part A participants will be randomized into 2 treatment dose groups at a 1:1 ratio. Part B is non-randomized.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,153 participants (actual)
Sponsor and investigators
- Lead sponsor
- ModernaTX, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06067230
- Sponsor's protocol ID
- mRNA-1345-P303
- Status last verified
- Aug 2026
- First submitted
- 27 Sep 2023
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Mayer EF, Falsey AR, Wolfe CR, Herc E, Burns F, Kabbani D, Kumar D, Mannan A, She F, Lan L, McGrath S, Kapoor A, Priddy F. Respiratory Syncytial Virus Vaccination in Solid Organ Transplant Recipients: Interim Findings From a Phase 3 Trial of mRNA-1345. Clin Infect Dis. 2026 May 20;82(5):e1112-e1121. doi: 10.1093/cid/ciag108.
PubMed 41711453Mayer EF, Falsey AR, Clark R, Ferguson M, Cardona J, She F, Jones B, Reuter C, Collins A, Mannan A, Kapoor A, Slobod K, Stoszek SK, Du J, Mou J, Lan L, Zhou H, Wilson E, Goswami J, Das R, Priddy F. Safety, Tolerability, and Immunogenicity of mRNA-1345 in Adults at Increased Risk for Respiratory Syncytial Virus Disease Aged 18-59 Years. Clin Infect Dis. 2026 Feb 4;81(6):e708-e716. doi: 10.1093/cid/ciaf292.
PubMed 40464662
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Study to Evaluate the Immunogenicity and Safety of mRNA-1345, an mRNA Vaccine Targeting Respiratory Syncytial Virus, in High-Risk Adults
- ClinicalTrials.gov ID
- NCT06067230
- Acronym / sponsor ID
- mRNA-1345-P303
- Conditions
- Respiratory Syncytial Virus
- Keywords
- Viral Diseases, Messenger RNA, Moderna, mRNA-1345, Respiratory syncytial virus, Safety, Vaccines, Immunocompromised
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,153 participants (actual)
- Lead sponsor
- ModernaTX, Inc.Industry (pharma, biotech, devices)
- Study start
- 6 Oct 2023 (actual)
- Primary completion
- 24 Jul 2026 (actual)
- Study completion
- 24 Jul 2026 (actual)
- First posted
- 4 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is divided into 2 parts (Part A and Part B). Part A of the study will evaluate the safety and immune response to mRNA-1345 in high-risk adults aged ≥18 to <60 years.
Part B of the study will evaluate the safety and immune response to mRNA-1345 in adults who received solid organ transplant (SOT).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Part A participants will be randomized into 2 treatment dose groups at a 1:1 ratio. Part B is non-randomized.
| Arm | Type | Receives |
|---|---|---|
| Part A: mRNA-1345 Dose 1 | Experimental | Biological: mRNA-1345Single injection of mRNA-1345 administered intramuscularly (IM) on Day 1. |
| Part A: mRNA-1345 Dose 2 | Experimental | Biological: mRNA-1345Single injection of mRNA-1345 administered IM on Day 1. |
| Part B: mRNA-1345 Dose 2 | Experimental | Biological: mRNA-1345Two injections of mRNA-1345 administered IM on Day 1 and Day 57. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adults ≥18 to <60 years of age at the time of consent who are primarily responsible for self-care and activities of daily living.
- Documented confirmation by a physician of the diagnosis of at least one of the following conditions:
- Adults ≥18 years of age at the time of consent who are primarily responsible for self-care and activities of daily living.
- Recipient of an SOT (kidney, liver, or lung transplant) ≥180 days prior to day of consent and receiving chronic immunosuppressive therapy for the prevention of allograft rejection.
- Able to comply with study requirements.
Key exclusion criteria (12 listed)
- Participation in an another clinical research trial where the participant has received an investigational product 180 days prior to Day 1. Participation in an RSV trial at any time prior to Day 1 is exclusionary.
- History of a diagnosis or condition, that, in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures.
- Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of the mRNA-1345 injection or any components of the mRNA-1345 injection.
- Chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 180 days prior to Day 1.
- History of myocarditis, pericarditis, or myopericarditis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mRNA-1345Sterile liquid for injection | Biological | Part A: mRNA-1345 Dose 1, Part A: mRNA-1345 Dose 2, Part B: mRNA-1345 Dose 2 |
Primary outcome
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Time frame: Day 1 through Day 7 (7 days post injection) for Part A and Day 1 through Day 64 (7 days post second injection) for Part B
Number of Participants with Unsolicited Adverse Events (AEs)
Time frame: Day 1 through Day 28 (28 days post injection) for Part A and Day 1 through Day 84 (28 days post second injection) for Part B
Number of Participants With Medically Attended AEs (MAAEs)
Time frame: Day 1 through Month 6 (for Part A) and Day 1 through Month 9 (for Part B)
Number of Participants With Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and AEs Leading to Discontinuation
Time frame: Day 1 through End of Study (Day 730)
Part A: Geometric Mean Titer (GMT) of Serum Respiratory Syncytial Virus Subtype A (RSV-A) and Respiratory Syncytial Virus Subtype B (RSV-B) Neutralizing Antibodies (Abs) at Day 29
Time frame: Day 29
Part B: GMT of Serum RSV-A and RSV-B Neutralizing Abs at Day 85
Time frame: Day 85
21 secondary outcomes
Part A: Seroresponse Rate (SRR) of RSV-A and RSV-B Neutralizing Abs on Day 29
Time frame: Day 29
Part A: Geometric Mean Concentration (GMC) of Serum RSV Prefusion Conformation of the F Protein (Pre-F) Binding Abs
Time frame: Up to End of Study (Day 730)
Part A: Geometric Mean Fold-Rise (GMFR) of Serum RSV Pre-F Binding Abs
Time frame: Up to End of Study (Day 730)
Part A: SRR of Serum RSV Pre-F Binding Abs at Postbaseline/Baseline Levels
Time frame: Baseline up to Day 730
Part A: Number of Participants with ≥2-Fold Increase in RSV Pre-F Binding Abs
Time frame: Up to End of Study (Day 730)
Part A: GMT of Serum RSV-A and RSV-B Neutralizing Abs at Day 29
Time frame: Day 29
Part A: GMT of Postinjection/Baseline Titers to RSV-A and RSV-B Neutralizing Abs
Time frame: Baseline up to Day 730
Part A: GMFR of Postinjection/Baseline Titers to RSV-A and RSV-B Neutralizing Abs
Time frame: Baseline up to Day 730
Part A: SRR of Serum RSV-A and RSV-B Neutralizing Abs
Time frame: Up to End of Study (Day 730)
Part A: Number of Participants with ≥2-Fold Increase in RSV-A and RSV-B Neutralizing Abs Titers
Time frame: Up to End of Study (Day 730)
Part B: GMT of Serum RSV-A and RSV-B Neutralizing Abs at Day 29
Time frame: Day 29
Part B: SRR of Serum RSV-A and RSV-B Neutralizing Abs on Day 29
Time frame: Day 29
Part B: SRR of Serum RSV-A and RSV-B Neutralizing Abs on Day 85
Time frame: Day 85
Part B: GMT of Serum RSV-A and RSV-B Neutralizing Abs
Time frame: Up to End of Study (Day 730)
Part B: GMFR of Serum RSV-A and RSV-B Neutralizing Abs
Time frame: Up to End of Study (Day 730)
Part B: SRR of Serum RSV-A and RSV-B Neutralizing Abs at Postbaseline/Baseline Levels
Time frame: Baseline up to Day 730
Part B: Number of Participants with ≥2-Fold Increase in RSV-A and RSV-B Neutralizing Abs
Time frame: Up to End of Study (Day 730)
Part B: GMC of Serum RSV Pre-F Binding Abs
Time frame: Up to End of Study (Day 730)
Part B: GMFR of Serum RSV Pre-F Binding Abs
Time frame: Up to End of Study (Day 730)
Part B: SRR of Serum RSV Pre-F Binding Abs at Postbaseline/Baseline Levels
Time frame: Baseline up to End of Study (Day 730)
Part B: Number of Participants with ≥2-Fold Increase in RSV Pre-F Binding Abs
Time frame: Up to End of Study (Day 730)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Derived from this study: PubMed 41711453Mayer EF, Falsey AR, Wolfe CR, Herc E, Burns F, Kabbani D, Kumar D, Mannan A, She F, Lan L, McGrath S, Kapoor A, Priddy F. Respiratory Syncytial Virus Vaccination in Solid Organ Transplant Recipients: Interim Findings From a Phase 3 Trial of mRNA-1345. Clin Infect Dis. 2026 May 20;82(5):e1112-e1121. doi: 10.1093/cid/ciag108.
- Derived from this study: PubMed 40464662Mayer EF, Falsey AR, Clark R, Ferguson M, Cardona J, She F, Jones B, Reuter C, Collins A, Mannan A, Kapoor A, Slobod K, Stoszek SK, Du J, Mou J, Lan L, Zhou H, Wilson E, Goswami J, Das R, Priddy F. Safety, Tolerability, and Immunogenicity of mRNA-1345 in Adults at Increased Risk for Respiratory Syncytial Virus Disease Aged 18-59 Years. Clin Infect Dis. 2026 Feb 4;81(6):e708-e716. doi: 10.1093/cid/ciaf292.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
44 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing mRNA-1345 in people with Respiratory Syncytial Virus, run by ModernaTX, Inc. at 44 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States, Canada, United Kingdom, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) (time frame: Day 1 through Day 7 (7 days post injection) for Part A and Day 1 through Day 64 (7 days post second injection) for Part B). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06067230, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.