Respiratory Syncytial VirusPhase 2NCT07810010
Phase 2b Study of a Respiratory Syncytial Virus and Human Metapneumovirus (RSV+HMPV) Protein Vaccine Candidate in Adults 60 Years of Age and Older
A Phase 2 study testing Bivalent RSV+HMPV protein vaccine in people with Respiratory Syncytial Virus and Human Metapneumovirus, run by Sanofi at 21 sites in 2 countries.
Trial summary
Study VCA25397 is a Phase 2b, observer-blind, randomized, placebo-controlled, parallel, case-driven proof of concept study that will enroll approximately 8000 adults aged 60 years and older to assess the clinical efficacy, safety, and immunogenicity of a single IM (intramuscular) injection of the bivalent RSV+HMPV… 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, Human Metapneumovirus, Healthy Volunteers
- What is being tested?
- Bivalent RSV+HMPV protein vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8,000 participants
- Where
- 21 sitesin 2 countries
- Study dates
- 9 Sep 2026to 5 Jul 2028
- Phase
- Phase 2
- 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
- Aged 60 years or older on the day of inclusion
- Participants who, as determined by medical evaluation including medical history, physical examination, and clinical judgment of the Investigator are eligible for inclusion
Who cannot join
- Known/suspected immunodeficiency; immunosuppressive therapy/immunomodulators in past 6 months; long-term systemic corticosteroids (eg, prednisone for more than 2 weeks in past 3 months); history of immune-mediated neurological disease. Of note, persons living with stable HIV are not excluded
- Known systemic hypersensitivity to any of the study intervention components or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
- Previous history of Guillain-Barré Syndrome (GBS)
- Previous vaccination against RSV and/or HMPV (with a licensed or investigational vaccine either as a monovalent vaccine or any combination of the antigens) or previous receipt of RSV and/or HMPV monoclonal antibody
- The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Trial locations and contacts
21 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Trial Transparency email recommended (Toll free for US & Canada) contact
21 sites in 2 countries
United Kingdom15 sites, 15 recruiting
- Recruiting
Investigational Site Number : 8260002
Blackpool, Lancashire, FY3 7EN
- Recruiting
Investigational Site Number : 8261010
Bournemouth, Dorset, BH7 7DW
- Recruiting
Investigational Site Number : 8260003
Bradford, BD9 6DA
- Recruiting
Investigational Site Number : 8260009
Bromborough, Wirral, CH62 6EE
- Recruiting
Investigational Site Number : 8260012
Cardiff, Cardiff [Caerdydd Gb-crd], CF15 9SS
- Recruiting
Investigational Site Number : 8260001
Corby, Northamptonshire, NN17 2UN
- Recruiting
Investigational Site Number : 8263010
Dorchester, Dorset, DT1 2JY
- Recruiting
Investigational Site Number : 8260013
London, England, E1 2AX
- Recruiting
Investigational Site Number : 8260011
London, England, SW10 9NH
- Recruiting
Investigational Site Number : 8260007
London, London, City of, NW10 2PB
- Recruiting
Investigational Site Number : 8260004
London, SW10 0LR
- Recruiting
Investigational Site Number : 8262010
Portsmouth, Hampshire, PO6 3LY
- Recruiting
Investigational Site Number : 8260008
Stockton-on-Tees, TS19 8PE
- Recruiting
Investigational Site Number : 8260006
West Kirby, Wirral, CH48 5AA
- Recruiting
Investigational Site Number : 8260005
Witney, Oxfordshire, OX28 6JS
Australia6 sites, 6 recruiting
- Recruiting
Investigational Site Number : 0360002
Albion, Queensland, 4010
- Recruiting
Investigational Site Number : 0360006
Blacktown, New South Wales, 2148
- Recruiting
Investigational Site Number : 0360008
Bruse, Australian Capital Territory, 2617
- Recruiting
Investigational Site Number : 0360007
Maroubra, New South Wales, 2035
- Recruiting
Investigational Site Number : 0360009
Melbourne, Victoria, 3124
- Recruiting
Investigational Site Number : 0360003
Sippy Downs, Queensland, 4556
About this study
Official title: A Phase 2b, Randomized, Placebo-controlled, Observer-blind Study in Adults 60 Years of Age and Older to Evaluate the Efficacy, Safety, and Immunogenicity of a Bivalent Protein Vaccine Candidate Against Respiratory Syncytial Virus (RSV) and Human Metapneumovirus (HMPV)
Study VCA25397 is a Phase 2b, observer-blind, randomized, placebo-controlled, parallel, case-driven proof of concept study that will enroll approximately 8000 adults aged 60 years and older to assess the clinical efficacy, safety, and immunogenicity of a single IM (intramuscular) injection of the bivalent RSV+HMPV protein vaccine candidate.
The study will include a Safety Lead-in Cohort that will be enrolled first and will comprise 200 participants aged 60 years and older randomized in a 1:1 ratio to receive either RSV+HMPV protein vaccine or placebo (100 participants per arm).
The enrollment of the Main Cohort will start after the completion of the ESDR (Early Safety Data Review), pending a positive outcome. For the Main Cohort, 7800 participants (3900 participants per arm) will be randomized in a 1:1 ratio to receive either RSV+HMPV protein vaccine or placebo.
- Being tested
- Bivalent RSV+HMPV protein vaccine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bivalent RSV+HMPV protein vaccineBiological
Also called RPF08203
IM injection
PlaceboBiological
IM injection
| Study group | Role | What they receive |
|---|---|---|
| Safety Lead-in Cohort - Experimental | Experimental | Single administration of IM (intramuscular) injection of the bivalent RSV+HMPV protein vaccine candidate Receives: Biological: Bivalent RSV+HMPV protein vaccine |
| Safety Lead-in Cohort - Placebo | Placebo comparator | Single administration of matching placebo Receives: Biological: Placebo |
| Main Cohort - Experimental | Experimental | Single administration of IM (intramuscular) injection of the bivalent RSV+HMPV protein vaccine candidate Receives: Biological: Bivalent RSV+HMPV protein vaccine |
| Main Cohort - Placebo | Placebo comparator | Single administration of matching placebo Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of the first episode of RSV-LRTD (Lower Respiratory Tract Disease)
Measured: From 14 days to 12 months after vaccination
Occurrence of the first episode of HMPV-LRTD
Measured: From 14 days to 12 months after vaccination
Secondary outcomes (12)
Occurrence of the first episode of RSV-LRTD and/or HMPV-LRTD
Measured: From 14 days to 12 months after vaccination
Occurrence of the first episode of RSV-ARD (Acute Respiratory Disease) and/or HMPV-ARD
Measured: From 14 days to 12 months after vaccination
Occurrence of the first episode of severe RSV-LRTD and/or severe HMPV-LRTD
Measured: From 14 days to 12 months after vaccination
Occurrence of the first episode of RSV-URTD and/or HMPV-URTD
Measured: From 14 days to 12 months after vaccination
RSV A, RSV B, and HMPV A, HMPV B serum nAb titers in a subset of participants
Measured: At pre-vaccination and 8 days, 28 days, 6 months and 12 months post- vaccination
Presence of immediate unsolicited systemic AEs (Adverse Events)
Measured: Within 30 minutes after vaccination
Presence of solicited injection site and systemic reactions in a subset of participants
Measured: Up to 7 days after vaccination
Presence of unsolicited AEs reported
Measured: Up to 27 days after vaccination
Presence of MAAEs (Medically Attended Adverse Events)
Measured: Within 6 months after vaccination
Presence of SAEs (Serious Adverse Events) and AESIs (Adverse Event of Special Interest)
Measured: Within 6 months after vaccination
Presence of related SAEs, related AESIs, and fatal SAEs
Measured: Up to 12 months post-vaccination
Presence of out-of-range biological test results in a subset of participants
Measured: 7 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start9 Sep 2026
- Primary completion3 Jul 2028 (estimated)
- Study completion5 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial VirusStudies of the same condition, open and under way.
- More trials run by SanofiThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07810010
- Sponsor's protocol ID
- VCA25397
- Other IDs
- 2026-526177-42, U1111-1337-5133
- Status last verified
- Oct 2026
- First submitted
- 3 Sep 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Randomized, Placebo-controlled, Observer-blind Study in Adults 60 Years of Age and Older to Evaluate the Efficacy, Safety, and Immunogenicity of a Bivalent Protein Vaccine Candidate Against Respiratory Syncytial Virus (RSV) and Human Metapneumovirus (HMPV)
- ClinicalTrials.gov ID
- NCT07810010
- Acronym / sponsor ID
- VCA25397
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 9 Sep 2026 (actual)
- Primary completion
- 3 Jul 2028 (estimated)
- Study completion
- 5 Jul 2028 (estimated)
- First posted
- 9 Sep 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.
Study VCA25397 is a Phase 2b, observer-blind, randomized, placebo-controlled, parallel, case-driven proof of concept study that will enroll approximately 8000 adults aged 60 years and older to assess the clinical efficacy, safety, and immunogenicity of a single IM (intramuscular) injection of the bivalent RSV+HMPV protein vaccine candidate.
The study will include a Safety Lead-in Cohort that will be enrolled first and will comprise 200 participants aged 60 years and older randomized in a 1:1 ratio to receive either RSV+HMPV protein vaccine or placebo (100 participants per arm).
The enrollment of the Main Cohort will start after the completion of the ESDR (Early Safety Data Review), pending a positive outcome. For the Main Cohort, 7800 participants (3900 participants per arm) will be randomized in a 1:1 ratio to receive either RSV+HMPV protein vaccine or placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Safety Lead-in Cohort - Experimental | Experimental | Biological: Bivalent RSV+HMPV protein vaccineSingle administration of IM (intramuscular) injection of the bivalent RSV+HMPV protein vaccine candidate |
| Safety Lead-in Cohort - Placebo | Placebo comparator | Biological: PlaceboSingle administration of matching placebo |
| Main Cohort - Experimental | Experimental | Biological: Bivalent RSV+HMPV protein vaccineSingle administration of IM (intramuscular) injection of the bivalent RSV+HMPV protein vaccine candidate |
| Main Cohort - Placebo | Placebo comparator | Biological: PlaceboSingle administration of matching placebo |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 60 years or older on the day of inclusion
- Participants who, as determined by medical evaluation including medical history, physical examination, and clinical judgment of the Investigator are eligible for inclusion
Key exclusion criteria (6 listed)
- Known/suspected immunodeficiency; immunosuppressive therapy/immunomodulators in past 6 months; long-term systemic corticosteroids (eg, prednisone for more than 2 weeks in past 3 months); history of immune-mediated neurological disease. Of note, persons living with stable HIV are not excluded
- Known systemic hypersensitivity to any of the study intervention components or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
- Previous history of Guillain-Barré Syndrome (GBS)
- Previous vaccination against RSV and/or HMPV (with a licensed or investigational vaccine either as a monovalent vaccine or any combination of the antigens) or previous receipt of RSV and/or HMPV monoclonal antibody
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 |
|---|---|---|
| Bivalent RSV+HMPV protein vaccineAlso: RPF08203IM injection | Biological | Main Cohort - Experimental, Safety Lead-in Cohort - Experimental |
| PlaceboIM injection | Biological | Main Cohort - Placebo, Safety Lead-in Cohort - Placebo |
Primary outcome
Occurrence of the first episode of RSV-LRTD (Lower Respiratory Tract Disease)
Time frame: From 14 days to 12 months after vaccination
Occurrence of the first episode of HMPV-LRTD
Time frame: From 14 days to 12 months after vaccination
12 secondary outcomes
Occurrence of the first episode of RSV-LRTD and/or HMPV-LRTD
Time frame: From 14 days to 12 months after vaccination
Occurrence of the first episode of RSV-ARD (Acute Respiratory Disease) and/or HMPV-ARD
Time frame: From 14 days to 12 months after vaccination
Occurrence of the first episode of severe RSV-LRTD and/or severe HMPV-LRTD
Time frame: From 14 days to 12 months after vaccination
Occurrence of the first episode of RSV-URTD and/or HMPV-URTD
Time frame: From 14 days to 12 months after vaccination
RSV A, RSV B, and HMPV A, HMPV B serum nAb titers in a subset of participants
Time frame: At pre-vaccination and 8 days, 28 days, 6 months and 12 months post- vaccination
Presence of immediate unsolicited systemic AEs (Adverse Events)
Time frame: Within 30 minutes after vaccination
Presence of solicited injection site and systemic reactions in a subset of participants
Time frame: Up to 7 days after vaccination
Presence of unsolicited AEs reported
Time frame: Up to 27 days after vaccination
Presence of MAAEs (Medically Attended Adverse Events)
Time frame: Within 6 months after vaccination
Presence of SAEs (Serious Adverse Events) and AESIs (Adverse Event of Special Interest)
Time frame: Within 6 months after vaccination
Presence of related SAEs, related AESIs, and fatal SAEs
Time frame: Up to 12 months post-vaccination
Presence of out-of-range biological test results in a subset of participants
Time frame: 7 days after vaccination
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 Oct 2026.
- VCA25397 Plain Language Results SummaryLink provided by the sponsor.
- For EU sites click here and navigate to 'Locations and contact points'.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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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.
Trial Transparency email recommended (Toll free for US & Canada) contact
21 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bivalent RSV+HMPV protein vaccine in people with Respiratory Syncytial Virus and Human Metapneumovirus, run by Sanofi at 21 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 6 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 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United Kingdom, Australia. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Trial Transparency email recommended (Toll free for US & Canada) (800-633-1610 ext. option 6, Contact-US@sanofi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of the first episode of RSV-LRTD (Lower Respiratory Tract Disease) (time frame: From 14 days to 12 months after vaccination). The study lists 2 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 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.