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Respiratory Syncytial Virus ImmunizationPhase 1/2NCT07734649

Phase 1/2 Study of Respiratory Syncytial Virus and Human Metapneumovirus (RSV+HMPV) Vaccine Candidate in Adults 60 Years of Age and Older

A Phase 1/2 study testing RSV+HMPV vaccine in people with Respiratory Syncytial Virus Immunization and Human Metapneumovirus Immunization, run by Sanofi at 50 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study is a Phase 1/2, randomized, observer-blind, active and placebo-controlled, multi-center study to be conducted in approximately 2400 adults 60 years of age and older. The aim of the study is to evaluate the immunogenicity and safety of an RSV+HMPV vaccine candidate for the prevention of RSV and HMPV disease… Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
What is being tested?
RSV+HMPV vaccine
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,400 participants
Where
50 sitesUnited States
Study dates
22 Jul 2026to 3 May 2028
Phase
Phase 1/2
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
  • Non-childbearing potential (ie, post-menopausal for at least 1 year or surgically sterile)

Who cannot join

  • History of laboratory-confirmed RSV and/or laboratory-confirmed HMPV infection affecting the participant and/or the participant's household in the previous 12 months
  • Previous history of myocarditis, pericarditis, and/or myopericarditis
  • Screening electrocardiogram (ECG) that is consistent with possible myocarditis, pericarditis, and/or myopericarditis or, in the opinion of the investigator, demonstrates clinically relevant abnormalities that may affect participant safety or study results
  • 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
  • Any vaccine given 4 weeks before or 4 weeks after study intervention
Show all 11Show fewer
  • Previous vaccination against RSV and/or HMPV with an investigational or marketed vaccine
  • Receipt of any mRNA vaccine/product in the 2 months preceding study intervention administration
  • Has received a blood transfusion or blood-derived products, including immunoglobulins, in the past 3 months
  • Any screening laboratory parameter with laboratory abnormality > Grade 1 or deemed clinically significant by the investigator; if deemed appropriate, investigator may repeat these assessments
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial locations and contacts

50 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Trial Transparency email recommended (Toll free for US & Canada) contact

800-633-1610 ext. option 6

Contact-US@sanofi.com

50 sites in 1 country

United States50 sites, 50 recruiting

  • DM Clinical Research - Albuquerque- Site Number : 8400051

    Albuquerque, New Mexico, 87106

    Recruiting

  • Velocity Clinical Research - Austin- Site Number : 8400013

    Austin, Texas, 78759

    Recruiting

  • Velocity Clinical Research - Cleveland- Site Number : 8400024

    Beachwood, Ohio, 44122

    Recruiting

  • Boston Clinical Trials- Site Number : 8400070

    Boston, Massachusetts, 02131

    Recruiting

  • DM Clinical Research - Brookline- Site Number : 8400055

    Brookline, Massachusetts, 02446

    Recruiting

  • Charlottesville Medical Research- Site Number : 8400062

    Charlottesville, Virginia, 22911

    Recruiting

  • Velocity Clinical Research - Springdale- Site Number : 8400014

    Cincinnati, Ohio, 45246

    Recruiting

  • Zenos Clinical Research- Site Number : 8400032

    Dallas, Texas, 75230

    Recruiting

  • Accel Research Sites - NeuroStudies- Site Number : 8400063

    Decatur, Georgia, 30030

    Recruiting

  • Accel Research Sites Network - DeLand Clinical Research Unit- Site Number : 8400064

    DeLand, Florida, 32720

    Recruiting

  • Velocity Clinical Research - Providence- Site Number : 8400018

    East Greenwich, Rhode Island, 02818

    Recruiting

  • Velocity Clinical Research - New Smyrna Beach- Site Number : 8400017

    Edgewater, Florida, 32132

    Recruiting

  • QUEST Research Institute- Site Number : 8400068

    Farmington Hills, Michigan, 48334

    Recruiting

  • Hawthorne Health - Gadsden- Site Number : 8400025

    Gadsden, Alabama, 35901

    Recruiting

  • Velocity Clinical Research - Hampton- Site Number : 8400015

    Hampton, Virginia, 23666

    Recruiting

  • DM Clinical Research - CyFair Clinical Research Center- Site Number : 8400058

    Houston, Texas, 77065

    Recruiting

  • Texas Center for Drug Development - Houston- Site Number : 8400043

    Houston, Texas, 77081

    Recruiting

  • Marvel Clinical Research- Site Number : 8400006

    Huntington Beach, California, 92647

    Recruiting

  • DM Clinical Research - Indianapolis- Site Number : 8400082

    Indianapolis, Indiana, 46254

    Recruiting

  • DM Clinical Research - Dallas- Site Number : 8400059

    Irving, Texas, 75061

    Recruiting

  • DM Clinical Research - New Jersey- Site Number : 8400044

    Jersey City, New Jersey, 07306

    Recruiting

  • Velocity Clinical Research - San Diego- Site Number : 8400019

    La Mesa, California, 91942

    Recruiting

  • Accel Research Sites - Lakeland Clinical Research Unit- Site Number : 8400073

    Lakeland, Florida, 33803

    Recruiting

  • Accel Research Sites - St. Petersburg - Largo- Site Number : 8400067

    Largo, Florida, 33777

    Recruiting

  • Alliance Clinical - Las Vegas- Site Number : 8400034

    Las Vegas, Nevada, 89109

    Recruiting

  • Velocity Clinical Research - Lincoln - Valley Road- Site Number : 8400016

    Lincoln, Nebraska, 68510

    Recruiting

  • Hawthorne - Bienstar Lindenwold- Site Number : 8400027

    Lindenwold, New Jersey, 08021

    Recruiting

  • Long Beach Research Institute- Site Number : 8400005

    Long Beach, California, 90805

    Recruiting

  • Accel Research Sites - Maitland Clinical Research Unit- Site Number : 8400074

    Maitland, Florida, 32751

    Recruiting

  • DM Clinical Research - Chicago- Site Number : 8400050

    Melrose Park, Illinois, 60160

    Recruiting

  • ActivMed Practices & Research - Methuen- Site Number : 8400066

    Methuen, Massachusetts, 01844

    Recruiting

  • Velocity Clinical Research - New Orleans- Site Number : 8400022

    New Orleans, Louisiana, 70119

    Recruiting

  • Coastal Carolina Research Center - North Charleston- Site Number : 8400061

    North Charleston, South Carolina, 29405

    Recruiting

  • Velocity Clinical Research - Omaha- Site Number : 8400012

    Omaha, Nebraska, 68134

    Recruiting

  • Alcanza - Innovation Medical Research Center - Palmetto- Site Number : 8400069

    Palmetto Bay, Florida, 33157

    Recruiting

  • Enspire Clinical Research- Site Number : 8400077

    Peoria, Illinois, 61614

    Recruiting

  • DM Clinical Research - Philadelphia- Site Number : 8400046

    Philadelphia, Pennsylvania, 19107

    Recruiting

  • DM Clinical Research - San Antonio - North San Saba- Site Number : 8400056

    San Antonio, Texas, 78207

    Recruiting

  • DM Clinical Research - San Antonio - North San Saba- Site Number : 8400057

    San Antonio, Texas, 78207

    Recruiting

  • Acclaim Clinical Research- Site Number : 8400033

    San Diego, California, 92120

    Recruiting

  • Dm Clinical - Seattle- Site Number : 8400047

    Seattle, Washington, 98122

    Recruiting

  • DM Clinical Research - Detroit- Site Number : 8400049

    Southfield, Michigan, 48076

    Recruiting

  • Hawthorne Health - Staten Island- Site Number : 8400026

    Staten Island, New York, 10309

    Recruiting

  • DM Clinical Research - Sugar Land- Site Number : 8400048

    Sugar Land, Texas, 77478

    Recruiting

  • Olympus Clinical Research - Sugar Land- Site Number : 8400071

    Sugar Land, Texas, 77478

    Recruiting

  • DM Clinical Research - Tomball- Site Number : 8400045

    Tomball, Texas, 77375

    Recruiting

  • DM Clinical Research - Tomball- Site Number : 8400081

    Tomball, Texas, 77375

    Recruiting

  • Accel Research Sites Network - Birmingham- Site Number : 8400065

    Vestavia Hills, Alabama, 35216

    Recruiting

  • Velocity Clinical Research - Washington DC- Site Number : 8400021

    Washington D.C., District of Columbia, 20016

    Recruiting

  • North Georgia Clinical Research- Site Number : 8400078

    Woodstock, Georgia, 30189

    Recruiting

Other trials in United States

About this study

Official title: A Phase 1/2, Randomized, Controlled, Observer-Blind Study in Adults 60 Years of Age and Older to Evaluate the Immunogenicity and Safety of Different Dose Levels of a Bivalent Vaccine Candidate Against Respiratory Syncytial Virus (RSV) and Human Metapneumovirus (HMPV)

This study is a Phase 1/2, randomized, observer-blind, active and placebo-controlled, multi-center study to be conducted in approximately 2400 adults 60 years of age and older. The aim of the study is to evaluate the immunogenicity and safety of an RSV+HMPV vaccine candidate for the prevention of RSV and HMPV disease among adults 60 years of age and older. While there are 3 FDA approved/licensed RSV vaccines currently available to the public, no vaccine is available for the prevention of HMPV in older adults. This study is intended to provide data in support of further clinical development of the RSV+HMPV vaccine candidate.

The study will consist of 4 cohorts and 11 vaccine groups (RSV+HMPV [6 dose levels], placebo and 4 control groups).

The duration of the study will be approximately 12 months for each participant.

Being tested
RSV+HMPV vaccine, Control Vaccine 3, Control Vaccine 4, Control Vaccine 2, Placebo
Keywords
RSV, HMPV

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RSV+HMPV vaccineBiological

    RSV + HMPV Candidate Vaccine

  • Control Vaccine 3Biological

    Control Vaccine 3

  • Control Vaccine 4Biological

    Control Vaccine 4

  • Control Vaccine 2Biological

    Control Vaccine 2

  • PlaceboOther

    Placebo

  • Control Vaccine 1Biological

    Control Vaccine 1

Study groups in NCT07734649
Study groupRoleWhat they receive
Group 1: RSV + HMPV Vaccine-Dose 1ExperimentalParticipants will receive RSV + HMPV vaccine corresponding to Dose 1 with a predefined antigen ratio
Receives: Biological: RSV+HMPV vaccine
Group 2: RSV + HMPV Vaccine-Dose 2ExperimentalParticipants will receive RSV + HMPV vaccine corresponding to Dose 2 with a predefined antigen ratio
Receives: Biological: RSV+HMPV vaccine
Group 3: RSV + HMPV Vaccine-Dose 3ExperimentalParticipants will receive RSV + HMPV vaccine corresponding to Dose 3 with a predefined antigen ratio
Receives: Biological: RSV+HMPV vaccine
Group 4: RSV + HMPV Vaccine-Dose 4ExperimentalParticipants will receive RSV + HMPV vaccine corresponding to Dose 4 with a predefined antigen ratio
Receives: Biological: RSV+HMPV vaccine
Group 5: RSV + HMPV Vaccine-Dose 5ExperimentalParticipants will receive RSV + HMPV vaccine corresponding to Dose 5 with a predefined antigen ratio
Receives: Biological: RSV+HMPV vaccine
Group 6: RSV + HMPV Vaccine-Dose 6ExperimentalParticipants will receive RSV + HMPV vaccine corresponding to Dose 6 with a predefined antigen ratio
Receives: Biological: RSV+HMPV vaccine
Group 7: Control Vaccine 1Active comparatorParticipants will receive control vaccine 1
Receives: Biological: Control Vaccine 1
Group 8: PlaceboPlacebo comparatorParticipants will receive Placebo
Receives: Other: Placebo
Group 9: Control Vaccine 2OtherParticipants will receive control vaccine 2 at a predefined dose and antigen ratio
Receives: Biological: Control Vaccine 2
Group 10: Control Vaccine 3OtherParticipants will receive control vaccine 3 at a predefined dose
Receives: Biological: Control Vaccine 3
Group 11: Control Vaccine 4OtherParticipants will receive control vaccine 4 at a predefined dose
Receives: Biological: Control Vaccine 4

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. RSV A serum nAb (neutralizing antibodies) titers

    nAb titers expressed as geometric mean titers (GMTs)

    Measured: At Day 1 and Day 29

  2. RSV B serum nAb titers

    nAb titers expressed as GMTs

    Measured: At Day 1 and Day 29

  3. HMPV A serum nAb titers

    nAb titers expressed as GMTs

    Measured: At Day 1 and Day 29

  4. HMPV B serum nAb titers

    nAb titers expressed as GMTs

    Measured: At Day 1 and Day 29

  5. Unsolicited systemic Adverse Events (AEs) that occur within 30 minutes after vaccination

    Number of participants reporting immediate unsolicited systemic AEs

    Measured: Within 30 minutes after vaccination

  6. Presence of solicited injection site and systemic reactions

    Number of participants reporting:

    • injection site reactions: pain, erythema and swelling
    • systemic reactions: fever, headache, fatigue and myalgia

    Measured: For 8 days, including the day of vaccination

  7. Presence of Unsolicited AEs

    Number of participants reporting unsolicited AEs

    Measured: For 28 days, including day of vaccination

  8. Presence of medically attended AEs (MAAEs)

    Number of participants reporting MAAEs

    Measured: Within 6 months after vaccination

  9. Presence of Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)

    Number of participants reporting SAEs and AESIs

    Measured: Throughout the study (approximately 12 months)

  10. Presence of out-of-range biological test results

    Number of participants with biological safety assessment values out of normal range (including shift from baseline values)

    Measured: At Day 09

Secondary outcomes (8)

  1. RSV A serum nAb titers at 3, 6, 9, and 12 months post-vaccination

    nAb titers expressed as geometric mean titers (GMTs)

    Measured: 3, 6, 9, and 12-months post-vaccination

  2. RSV B serum nAb titers at 3, 6, 9, and 12 months post-vaccination

    nAb titers expressed as GMTs

    Measured: 3, 6, 9, and 12 months post-vaccination

  3. HMPV A serum nAb titers at 3, 6, 9, and 12 months post-vaccination

    nAb titers expressed as GMTs

    Measured: 3, 6, 9, and 12 months post-vaccination

  4. HMPV B serum nAb titers at 3, 6, 9, and 12 months post-vaccination

    nAb titers expressed as GMTs

    Measured: 3, 6, 9, and 12 months post-vaccination

  5. Serum RSV preF immunoglobulin G (IgG) Ab concentrations at pre-vaccination (Day 01), and at 28 days (Day 29), 3, 6, 9, and 12 months post-vaccination

    Ab concentration expressed as geometric mean concentrations (GMCs)

    Measured: pre-vaccination (Day 01), and at 28 days (Day 29), 3, 6, 9, and 12 months post-vaccination

  6. Serum HMPV preF immunoglobulin G (IgG) Ab concentrations at pre-vaccination (Day 01), and at 28 days (Day 29), 3, 6, 9, and 12 months post-vaccination

    Ab concentration expressed as GMCs

    Measured: pre-vaccination (Day 01), and at 28 days (Day 29), 3, 6, 9, and 12 months post-vaccination

  7. Ratio of RSV A and RSV B serum nAb titer fold-rise over anti-preF IgG Ab concentration fold-rise at Day 29, 3, 6, 9, and 12 months post-vaccination, from pre vaccination (Day 01)

    Measured: Day 29, 3, 6, 9, and 12 months post-vaccination, from pre-vaccination (Day 01)

  8. Ratio of HMPV A and HMPV B serum nAb titer fold-rise over anti-preF IgG Ab concentration fold-rise at Day 29, 3, 6, 9, and 12 months post-vaccination, from pre vaccination (Day 01)

    Measured: Day 29, 3, 6, 9, and 12 months post-vaccination, from pre-vaccination (Day 01)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2026
  2. Study start22 Jul 2026
  3. Primary completion3 May 2028 (estimated)
  4. Study completion3 May 2028 (estimated)

Resources

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 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
2,400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07734649
Sponsor's protocol ID
VCA23395
Other IDs
U1111-1337-4718
Status last verified
Oct 2026
First submitted
21 Jul 2026
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing RSV+HMPV vaccine in people with Respiratory Syncytial Virus Immunization and Human Metapneumovirus Immunization, run by Sanofi at 50 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 2 inclusion and 11 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 14 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 50 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. 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 combined 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.

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?

RSV A serum nAb (neutralizing antibodies) titers (time frame: At Day 1 and Day 29). The study lists 10 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 NCT07734649.

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 14 Oct 2026.

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