Respiratory Syncytial Virus (RSV)Phase 1NCT07764237
A Study to Investigate Safety, Reactogenicity, and Immunogenicity of mRNA-1365 (Profile 2) in Older Healthy Adults
A Phase 1 study testing mRNA-1365 (Profile 2), mRNA-1345 (Profile 1) and mRNA-1345 (Profile 3) in people with Respiratory Syncytial Virus (RSV) and Human Metapneuomovirus (hMPV), run by ModernaTX, Inc. at 10 sites in 2 countries.
Trial summary
The main objective of this trial is to evaluate the safety, reactogenicity, and immunogenicity of study interventions across intervention groups 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 (RSV), Human Metapneuomovirus (hMPV)
- What is being tested?
- mRNA-1365 (Profile 2), mRNA-1345 (Profile 1) and mRNA-1345 (Profile 3)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 375 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 11 Aug 2026to 20 Jul 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- In good general health or with stable chronic medical conditions, as determined by medical evaluation including medical history and physical examination.
- Body mass index within the range 18.5 to 35 kg/m2 (inclusive).
Who cannot join
- History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any mRNA vaccine or therapeutic, or any components of an mRNA vaccine or therapeutic.
- Abnormal screening clinical laboratory values for total white blood cell count, hemoglobin, hematocrit, alanine aminotransferase, aspartate aminotransferase, creatinine, alkaline phosphatase, or total bilirubin >Grade 1, or platelets ≥Grade 1.
- History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable, potentially affects participant safety, the assessment of study endpoints, the assessment of immune response, or adherence to study procedures.
- History of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infectious disease.
- Participants with immune-mediated (autoimmune) conditions are generally excluded.
- Received a licensed RSV vaccine or participated in a study in which vaccines against RSV and/or hMPV were administered to participants alone, or as part of a combination vaccine, at any time in the past.
- Note: Other inclusion and exclusion criteria may apply.
Trial locations and contacts
10 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
10 sites in 2 countries
United Kingdom8 sites, 8 recruiting
- Not yet recruiting
University Hospital Birmingham, NHS
Birmingham, West Midlands, B15 2TH
- Not yet recruiting
Royal Free Hospital, NHS
London, NW3 2QG
- Not yet recruiting
Guys and St. Thomas Hospital, NHS
London, SE1 7EH
- Not yet recruiting
St. George University Hospital, NHS
London, SW17 0RE
- Not yet recruiting
MAC Clinical Research
Manchester, Greater Manchester, M13 9NQ
- Not yet recruiting
Royal Victoria Infirmary, NHS
Newcastle, NE1 4LP
- Not yet recruiting
Norfolk and Norwich University Hospital, NHS
Norwich, Norfolk, NR4 7UQ
- Not yet recruiting
Southampton General Hospital, NHS
Southampton, Hampshire, SO16 6YD
Canada2 sites, 2 recruiting
- Recruiting
Diex Recherche Quebec
Québec, Quebec, G1V 4T3
- Recruiting
Diex Recherche Victoraville
Victoriaville, Quebec, G6P 3Z8
About this study
Official title: A Phase 1, Randomized, Open-label Staggered Dose-escalation and Observer-blind Expansion Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of the Multicomponent Vaccine mRNA-1365 (Profile 2 [RSV and hMPV]) in Healthy Adults ≥60 Years of Age
The main objective of this trial is to evaluate the safety, reactogenicity, and immunogenicity of study interventions across intervention groups
- Being tested
- mRNA-1365 (Profile 2), mRNA-1345 (Profile 1), mRNA-1345 (Profile 3)
- Keywords
- Respiratory Syncytial Virus (RSV), Human Metapneuomovirus (hMPV), Vaccine, Moderna, Respiratory Viral Infection, mRNA-1365 (Profile 2), Older Adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA-1365 (Profile 2)Biological
Sterile liquid for injection
mRNA-1345 (Profile 1)Biological
Sterile liquid for injection
mRNA-1345 (Profile 3)Biological
Sterile liquid for injection
| Study group | Role | What they receive |
|---|---|---|
| mRNA-1365 (Profile 2) Dose Level 1 | Experimental | Participants will receive 1 injection of mRNA-1365 (Profile 2) at Dose Level 1 on Day 1. Receives: Biological: mRNA-1365 (Profile 2) |
| mRNA-1365 (Profile 2) Dose Level 2 | Experimental | Participants will receive 1 injection of mRNA-1365 (Profile 2) at Dose Level 2 on Day 1. Receives: Biological: mRNA-1365 (Profile 2) |
| mRNA-1365 (Profile 2) Dose Level 3 | Experimental | Participants will receive 1 injection of mRNA-1365 (Profile 2) at Dose Level 3 on Day 1. Receives: Biological: mRNA-1365 (Profile 2) |
| mRNA-1345 (Profile 1) | Active comparator | Participants will receive 1 injection of mRNA-1345 (Profile 1) on Day 1. Receives: Biological: mRNA-1345 (Profile 1) |
| mRNA-1345 (Profile 3) | Active comparator | Participants will receive 1 injection of mRNA-1345 (Profile 3) on Day 1. Receives: Biological: mRNA-1345 (Profile 3) |
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: Up to Day 7 (the day of study intervention and 6 subsequent days)
Number of Participants with Unsolicited Adverse Events (AEs)
Measured: Up to Day 28 (the day of study intervention and 27 subsequent days)
Number of Participants with Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), Any AEs Leading to Study Discontinuation, and AEs of Special Interest (AESIs)
Measured: Up to End of Study (EOS) (Day 181)
Secondary outcomes (3)
Geometric Mean Level of Serum Neutralizing Antibodies (nAbs)
Measured: Day 29
Geometric Mean Fold Rise (GMFR) of Serum Neutralizing Antibodies (nAbs)
Measured: Day 29
Percentage of Particpants with Seroresponse Based on Serum Neutralizing Antibodies (nAbs) Level
Measured: Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start11 Aug 2026
- Primary completion20 Jul 2027 (estimated)
- Study completion20 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus (RSV)Studies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 375 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ModernaTX, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07764237
- Sponsor's protocol ID
- mRNA-1365P2-P101
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open-label Staggered Dose-escalation and Observer-blind Expansion Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of the Multicomponent Vaccine mRNA-1365 (Profile 2 [RSV and hMPV]) in Healthy Adults ≥60 Years of Age
- ClinicalTrials.gov ID
- NCT07764237
- Acronym / sponsor ID
- mRNA-1365P2-P101
- Keywords
- Respiratory Syncytial Virus (RSV), Human Metapneuomovirus (hMPV), Vaccine, Moderna, Respiratory Viral Infection, mRNA-1365 (Profile 2), Older Adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 375 participants (estimated)
- Lead sponsor
- ModernaTX, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Aug 2026 (actual)
- Primary completion
- 20 Jul 2027 (estimated)
- Study completion
- 20 Jul 2027 (estimated)
- First posted
- 13 Aug 2026 (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 main objective of this trial is to evaluate the safety, reactogenicity, and immunogenicity of study interventions across intervention groups
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| mRNA-1365 (Profile 2) Dose Level 1 | Experimental | Biological: mRNA-1365 (Profile 2)Participants will receive 1 injection of mRNA-1365 (Profile 2) at Dose Level 1 on Day 1. |
| mRNA-1365 (Profile 2) Dose Level 2 | Experimental | Biological: mRNA-1365 (Profile 2)Participants will receive 1 injection of mRNA-1365 (Profile 2) at Dose Level 2 on Day 1. |
| mRNA-1365 (Profile 2) Dose Level 3 | Experimental | Biological: mRNA-1365 (Profile 2)Participants will receive 1 injection of mRNA-1365 (Profile 2) at Dose Level 3 on Day 1. |
| mRNA-1345 (Profile 1) | Active comparator | Biological: mRNA-1345 (Profile 1)Participants will receive 1 injection of mRNA-1345 (Profile 1) on Day 1. |
| mRNA-1345 (Profile 3) | Active comparator | Biological: mRNA-1345 (Profile 3)Participants will receive 1 injection of mRNA-1345 (Profile 3) on Day 1. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- In good general health or with stable chronic medical conditions, as determined by medical evaluation including medical history and physical examination.
- Body mass index within the range 18.5 to 35 kg/m2 (inclusive).
Key exclusion criteria (7 listed)
- History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any mRNA vaccine or therapeutic, or any components of an mRNA vaccine or therapeutic.
- Abnormal screening clinical laboratory values for total white blood cell count, hemoglobin, hematocrit, alanine aminotransferase, aspartate aminotransferase, creatinine, alkaline phosphatase, or total bilirubin >Grade 1, or platelets ≥Grade 1.
- History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable, potentially affects participant safety, the assessment of study endpoints, the assessment of immune response, or adherence to study procedures.
- History of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infectious disease.
- Participants with immune-mediated (autoimmune) conditions are generally excluded.
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-1365 (Profile 2)Sterile liquid for injection | Biological | mRNA-1365 (Profile 2) Dose Level 1, mRNA-1365 (Profile 2) Dose Level 2, mRNA-1365 (Profile 2) Dose Level 3 |
| mRNA-1345 (Profile 1)Sterile liquid for injection | Biological | mRNA-1345 (Profile 1) |
| mRNA-1345 (Profile 3)Sterile liquid for injection | Biological | mRNA-1345 (Profile 3) |
Primary outcome
Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)
Time frame: Up to Day 7 (the day of study intervention and 6 subsequent days)
Number of Participants with Unsolicited Adverse Events (AEs)
Time frame: Up to Day 28 (the day of study intervention and 27 subsequent days)
Number of Participants with Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), Any AEs Leading to Study Discontinuation, and AEs of Special Interest (AESIs)
Time frame: Up to End of Study (EOS) (Day 181)
3 secondary outcomes
Geometric Mean Level of Serum Neutralizing Antibodies (nAbs)
Time frame: Day 29
Geometric Mean Fold Rise (GMFR) of Serum Neutralizing Antibodies (nAbs)
Time frame: Day 29
Percentage of Particpants with Seroresponse Based on Serum Neutralizing Antibodies (nAbs) Level
Time frame: Day 29
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
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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.
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing mRNA-1365 (Profile 2), mRNA-1345 (Profile 1) and mRNA-1345 (Profile 3) in people with Respiratory Syncytial Virus (RSV) and Human Metapneuomovirus (hMPV), run by ModernaTX, Inc. at 10 sites in 2 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 2 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 19 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 10 sites in United Kingdom, Canada. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Moderna WeCareTeam (1-866-663-3762, WeCareClinicalTrials@modernatx.com), or a site near the patient. 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: Up to Day 7 (the day of study intervention and 6 subsequent days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2026.