Respiratory Syncytial VirusPhase 3NCT07117487
A Study of mRNA-1345 Following a Primary Dose of a Licensed Protein Subunit Respiratory Syncytial Virus (RSV) Vaccine in Adult Participants ≥60 Years of Age
A Phase 3 study testing mRNA-1345 in people with Respiratory Syncytial Virus, run by ModernaTX, Inc. at 11 sites in United States.
Trial summary
The purpose of this study is to evaluate safety, tolerability and immunogenicity of mRNA-1345 in participants who have been previously vaccinated with either Arexvy or Abrysvo at least 12 months prior to enrollment, are medically stable and aged ≥60 years. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- 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
- 507 participants
- Where
- 11 sitesUnited States
- Study dates
- 5 Aug 2025to 27 Mar 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants may have one or more chronic medical diagnoses, but should be medically stable as assessed by:
- Absence of changes in medical therapy within 60 days of Visit 1 due to treatment failure or toxicity.
- Absence of serious or significant medical events within 30 days of Visit 1.
- Absence of known, current, and life-limiting diagnoses which, in the opinion of the Investigator, would make completion of the protocol unlikely.
- Participant has received a single dose of Arexvy or Abrysvo at least 12 months prior to Visit 1. Participants must provide proof of RSV vaccination status (including brand and date received) prior to enrollment.
Who cannot join
- Participant has received or plans to receive any vaccine authorized or approved by a local health agency ≤14 days prior to study injection (Day 1) or plans to receive a vaccine authorized or approved by a local health agency within 14 days after the study injection. Nonstudy vaccination(s) should not be delayed.
- Prior participation in research involving receipt of any investigational RSV product (drug/biologic).
- Has received systemic immunoglobulins, long-acting biological therapies that affect immune responses (for example, infliximab) or blood products within 90 days prior to Visit 1 or plans to receive them during the study.
- Other protocol-specified inclusion and/or exclusion criteria may apply.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Velocity Clinical Research, Austin
Austin, Texas, 78759
Velocity Clinical Research, Covington
Covington, Louisiana, 70433
Velocity Clinical Research, Denver
Denver, Colorado, 80110
Velocity Clinical Research, Hampton
Hampton, Virginia, 23666
Indago Research & Health Center, Inc.
Hialeah, Florida, 33012
Velocity Clinical Research, Lincoln
Lincoln, Nebraska, 68510
Velocity Clinical Research, Medford
Medford, Oregon, 97504
Velocity Clinical Research, Rockville
Rockville, Maryland, 20854
Velocity Clinical Research, Savannah
Savannah, Georgia, 31406
Velocity Clinical Research, Spokane
Spokane, Washington, 99218
Velocity Clinical Research, Valparaiso
Valparaiso, Indiana, 46383
About this study
Official title: A Phase 3 Open-label Study to Evaluate Safety, Tolerability, and Immunogenicity of Revaccination With mRNA-1345 at Least 12 Months Following a Primary Dose of a Licensed Protein Subunit RSV Vaccine in Adult Participants ≥60 Years of Age
The purpose of this study is to evaluate safety, tolerability and immunogenicity of mRNA-1345 in participants who have been previously vaccinated with either Arexvy or Abrysvo at least 12 months prior to enrollment, are medically stable and aged ≥60 years.
- Conditions
- Respiratory Syncytial Virus
- Being tested
- mRNA-1345
- Keywords
- Viral Diseases, Messenger RNA, Moderna, mRNA-1345, Respiratory syncytial virus, Safety, Vaccines
- 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
Suspension for injection
| Study group | Role | What they receive |
|---|---|---|
| mRNA-1345 | Experimental | Participants will receive a single dose of mRNA-1345 injection administered intramuscularly on Day 1. 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 up to Day 7 (7 days post-injection)
Number of Participants with Unsolicited Adverse Events (AEs)
Measured: Day 1 up to Day 28 (28 days post-injection)
Number of Participants with Medically Attended AEs (MAAEs), Serious AEs (SAEs), AEs of Special Interest (AESIs), and AEs Leading to Discontinuation
Measured: Day 1 up to Day 181 (End of study)
Geometric Mean Titer (GMT) of Serum RSV-A Neutralizing Antibodies (Abs) at Day 29
Measured: Day 29
GMT of Serum RSV-B Neutralizing Abs at Day 29
Measured: Day 29
Secondary outcomes (8)
GMT of Serum RSV-A Neutralizing Abs
Measured: Day 1 up to Day 181 (End of study)
Geometric Mean Fold Rise (GMFR) of Serum RSV-A Neutralizing Abs
Measured: Day 181
GMT of Serum RSV-B Neutralizing Abs
Measured: Day 1 up to Day 181 (End of study)
GMFR of Serum RSV-B Neutralizing Abs
Measured: Day 181
Percentage of Participants With Seroresponse in RSV-A Neutralizing Abs
Measured: Day 181
Percentage of Participants With Seroresponse in RSV-B Neutralizing Abs
Measured: Day 181
Percentage of Participants With ≥2-fold Increase From Baseline in RSV-A Neutralizing Ab Titers
Measured: Day 181
Percentage of Participants With ≥2-fold Increase From Baseline in RSV-B Neutralizing Ab Titers
Measured: Day 181
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start5 Aug 2025
- Primary completion27 Mar 2026
- Study completion27 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 507 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
- NCT07117487
- Sponsor's protocol ID
- mRNA-1345-P306
- Status last verified
- Apr 2026
- First submitted
- 5 Aug 2025
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Desai M, Cardona J, Khetan S, Mehta S, Kapoor A, Okparavero A, Lin Z, Priddy F. Safety and immunogenicity of mRNA-1345 revaccination at least 12 months following primary vaccination with a licensed protein subunit RSV vaccine. Vaccine. 2026 Sep 8;92:129068. doi: 10.1016/j.vaccine.2026.129068. Online ahead of print.
PubMed 42710149
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Open-label Study to Evaluate Safety, Tolerability, and Immunogenicity of Revaccination With mRNA-1345 at Least 12 Months Following a Primary Dose of a Licensed Protein Subunit RSV Vaccine in Adult Participants ≥60 Years of Age
- ClinicalTrials.gov ID
- NCT07117487
- Acronym / sponsor ID
- mRNA-1345-P306
- Conditions
- Respiratory Syncytial Virus
- Keywords
- Viral Diseases, Messenger RNA, Moderna, mRNA-1345, Respiratory syncytial virus, Safety, Vaccines
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 507 participants (actual)
- Lead sponsor
- ModernaTX, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Aug 2025 (actual)
- Primary completion
- 27 Mar 2026 (actual)
- Study completion
- 27 Mar 2026 (actual)
- First posted
- 12 Aug 2025 (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 purpose of this study is to evaluate safety, tolerability and immunogenicity of mRNA-1345 in participants who have been previously vaccinated with either Arexvy or Abrysvo at least 12 months prior to enrollment, are medically stable and aged ≥60 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mRNA-1345 | Experimental | Biological: mRNA-1345Participants will receive a single dose of mRNA-1345 injection administered intramuscularly on Day 1. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants may have one or more chronic medical diagnoses, but should be medically stable as assessed by:
- Participant has received a single dose of Arexvy or Abrysvo at least 12 months prior to Visit 1. Participants must provide proof of RSV vaccination status (including brand and date received) prior to enrollment.
Key exclusion criteria (4 listed)
- Participant has received or plans to receive any vaccine authorized or approved by a local health agency ≤14 days prior to study injection (Day 1) or plans to receive a vaccine authorized or approved by a local health agency within 14 days after the study injection. Nonstudy vaccination(s) should not be delayed.
- Prior participation in research involving receipt of any investigational RSV product (drug/biologic).
- Has received systemic immunoglobulins, long-acting biological therapies that affect immune responses (for example, infliximab) or blood products within 90 days prior to Visit 1 or plans to receive them during the study.
- Other protocol-specified inclusion and/or exclusion criteria may apply.
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-1345Suspension for injection | Biological | mRNA-1345 |
Primary outcome
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Time frame: Day 1 up to Day 7 (7 days post-injection)
Number of Participants with Unsolicited Adverse Events (AEs)
Time frame: Day 1 up to Day 28 (28 days post-injection)
Number of Participants with Medically Attended AEs (MAAEs), Serious AEs (SAEs), AEs of Special Interest (AESIs), and AEs Leading to Discontinuation
Time frame: Day 1 up to Day 181 (End of study)
Geometric Mean Titer (GMT) of Serum RSV-A Neutralizing Antibodies (Abs) at Day 29
Time frame: Day 29
GMT of Serum RSV-B Neutralizing Abs at Day 29
Time frame: Day 29
8 secondary outcomes
GMT of Serum RSV-A Neutralizing Abs
Time frame: Day 1 up to Day 181 (End of study)
Geometric Mean Fold Rise (GMFR) of Serum RSV-A Neutralizing Abs
Time frame: Day 181
GMT of Serum RSV-B Neutralizing Abs
Time frame: Day 1 up to Day 181 (End of study)
GMFR of Serum RSV-B Neutralizing Abs
Time frame: Day 181
Percentage of Participants With Seroresponse in RSV-A Neutralizing Abs
Time frame: Day 181
Percentage of Participants With Seroresponse in RSV-B Neutralizing Abs
Time frame: Day 181
Percentage of Participants With ≥2-fold Increase From Baseline in RSV-A Neutralizing Ab Titers
Time frame: Day 181
Percentage of Participants With ≥2-fold Increase From Baseline in RSV-B Neutralizing Ab Titers
Time frame: Day 181
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 4 May 2026.
- Derived from this study: PubMed 42710149Desai M, Cardona J, Khetan S, Mehta S, Kapoor A, Okparavero A, Lin Z, Priddy F. Safety and immunogenicity of mRNA-1345 revaccination at least 12 months following primary vaccination with a licensed protein subunit RSV vaccine. Vaccine. 2026 Sep 8;92:129068. doi: 10.1016/j.vaccine.2026.129068. Online ahead of print.
Related trials for Respiratory Syncytial Virus
RecruitingPhase 3
Study to Learn About a Respiratory Syncytial Virus Vaccine in Children at High Risk of RSV Disease
Respiratory Syncytial Virus (RSV)
Active, not recruitingPhase 3
A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease
Respiratory Syncytial Virus Infections
Active, not recruitingPhase 1
A Phase 1 Study to Evaluate JCXH-108, an mRNA-based Vaccine Against RSV
Respiratory Syncytial Virus (RSV), Infectious Disease
RecruitingPhase 2
Immunogenicity of RSVPreF3 Vaccine in Immunocompromised Persons
Respiratory Syncytial Virus (RSV)
RecruitingObservational study
TARSILA Real-World Evidence Study
Respiratory Syncytial Virus (RSV), Maternal Immunization
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.
11 sites in 1 country: 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 11 sites in United States.
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 5 inclusion and 4 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 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. 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 up to Day 7 (7 days post-injection)). The study lists 5 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 NCT07117487, which also lists 1 linked publication.
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 4 May 2026.