Human Metapneumovirus ImmunizationPhase 1/2NCT06686654
Study of a Human Metapneumovirus/Respiratory Syncytial Virus mRNA Vaccine Candidate Encapsulated in a Lipid Nanoparticle-based Formulation in Adults Aged 60 Years and Older
A Phase 1/2 study testing Investigational hMPV/RSV vaccine, Investigational hMPV vaccine (monovalent) and Investigational RSV vaccine (monovalent) in people with Human Metapneumovirus Immunization and Respiratory Syncytial Virus Immunization, run by Sanofi Pasteur, a Sanofi Company at 24 sites in United States.
Trial summary
The aim of this study is to evaluate the safety and immunogenicity of a human metapneumovirus (hMPV) / respiratory syncytial virus (RSV) mRNA vaccine candidate encapsulated in a lipid nanoparticle (LNP) based formulation (hereafter referred to as hMPV/RSV vaccine) for the prevention of lower respiratory tract disease… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Human Metapneumovirus Immunization, Respiratory Syncytial Virus Immunization
- What is being tested?
- Investigational hMPV/RSV vaccine, Investigational hMPV vaccine (monovalent) and Investigational RSV vaccine (monovalent)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,530 participants
- Where
- 24 sitesUnited States
- Study dates
- 11 Nov 2024to 18 Jan 2027
- 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
- A female participant is eligible to participate if she is not pregnant or breastfeeding and is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year or surgically sterile
Who cannot join
- Any screening laboratory parameter with laboratory abnormality > Grade 1 deemed clinically significant by the investigator
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months). Of note, persons living with stable human immunodeficiency virus (HIV) are not excluded
- Known systemic hypersensitivity to any of the study intervention components (eg, polyethylene glycol, polysorbate); history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances; any allergic reaction (eg, anaphylaxis) after administration of an mRNA vaccine
- History of RSV and/or hMPV-associated illness, diagnosed serologically or microbiologically in the last 12 months
- Previous history of myocarditis, pericarditis, and/or myopericarditis
- Screening electrocardiogram 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
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- Laboratory-confirmed thrombocytopenia, contraindicating IM injection, based on investigator's judgment
- Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM injection, based on investigator's judgment
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
- Receipt of any vaccine other than mRNA vaccine in the 28 days preceding any study intervention administration or planned receipt of any vaccine other than mRNA vaccine in the 28 days following any study intervention administration
- Receipt of any mRNA vaccine in the 60 days preceding any study intervention administration or planned receipt of any mRNA vaccine in the 60 days following any study intervention administration
- Previous vaccination against RSV and/or hMPV (with a licensed or investigational vaccine either as a monovalent vaccine or any combination of the antigens)
- Receipt of immune globulins, blood, or blood-derived products in the past 3 months
- Note: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
Velocity Clinical Research - Austin- Site Number : 8400020
Cedar Park, Texas, 78613
Velocity Clinical Research - Springdale- Site Number : 8400004
Cincinnati, Ohio, 45246
Velocity Clinical Research - Denver- Site Number : 8400016
Englewood, Colorado, 80110
CenExel CNS-Garden Grove- Site Number : 8400017
Garden Grove, California, 92845
National Research Institute - Gardena- Site Number : 8400005
Gardena, California, 90247
Velocity Clinical Research - Hallandale Beach- Site Number : 8400022
Hallandale, Florida, 33009
Velocity Clinical Research - Hampton- Site Number : 8400026
Hampton, Virginia, 23666
National Research Institute - Huntington Park- Site Number : 8400014
Huntington Park, California, 90255
Velocity Clinical Research - San Diego- Site Number : 8400008
La Mesa, California, 91942
Velocity Clinical Research - Lincoln - Valley Road- Site Number : 8400023
Lincoln, Nebraska, 68510
Velocity Clinical Research Los Angeles- Site Number : 8400013
Los Angeles, California, 90017
National Research Institute - Panorama City- Site Number : 8400012
Los Angeles, California, 91402
Velocity Clinical Research - Medford- Site Number : 8400024
Medford, Oregon, 97504
Velocity Clinical Research - Meridian- Site Number : 8400003
Meridian, Idaho, 83642
Suncoast Research Associates - Miami - Sunset Drive- Site Number : 8400001
Miami, Florida, 33173
Providence Clinical Research - North Hollywood- Site Number : 8400018
North Hollywood, California, 91606
Velocity Clinical Research - Omaha- Site Number : 8400006
Omaha, Nebraska, 68134
Velocity Clinical Research - Kansas City- Site Number : 8400015
Overland Park, Kansas, 66210
Velocity Clinical Research, Phoenix- Site Number : 8400025
Phoenix, Arizona, 85006
Velocity Clinical Research - Rockville- Site Number : 8400011
Rockville, Maryland, 20854
Peninsula Research Associates- Site Number : 8400002
Rolling Hills Estates, California, 90274
Velocity Clinical Research - Seattle- Site Number : 8400019
Seattle, Washington, 98105
Velocity Clinical Research - Washington DC- Site Number : 8400007
Washington D.C., District of Columbia, 20016
Velocity Clinical Research - Salt Lake City- Site Number : 8400010
West Jordan, Utah, 84088
About this study
Official title: A Phase 1/2, Randomized, Observer-blind, Placebo-controlled Multi-arm Study to Evaluate the Safety and Immunogenicity of an hMPV/RSV mRNA Vaccine Candidate in Adult Participants Aged 60 Years and Older
The aim of this study is to evaluate the safety and immunogenicity of a human metapneumovirus (hMPV) / respiratory syncytial virus (RSV) mRNA vaccine candidate encapsulated in a lipid nanoparticle (LNP) based formulation (hereafter referred to as hMPV/RSV vaccine) for the prevention of lower respiratory tract disease (LRTD) caused by hMPV and/or RSV among adults aged 60 years and older.
The study will also evaluate the safety and immunogenicity of a booster vaccination using a bivalent hMPV/RSV mRNA vaccine candidate (hereafter referred to as RSV+hMPV mRNA vaccine candidate).
Read more
Overall, the study is designed to address the following goals:
- Assess the safety profile of the candidate formulations.
- Describe the immunogenicity profile of the candidate formulations.
- Select the vaccine formulations (dose) for future development.
- Assess the safety and immunogenicity of a booster vaccination with the RSV + hMPV mRNA vaccine candidate administered 12 months after primary vaccination with a licensed RSV vaccine.
The study duration is as follows:
-Six months each for the Sentinel and Main Cohorts; up to 12 months for the Expansion Cohort, and 6 additional months for the Booster Cohort
Treatment duration:
- Stage 1 Sentinel Cohort: 1 intra-muscular (IM) injection. Participants will be followed for 6 months post vaccination
- Stage 1 Main Cohort: 1 IM injection. Participants will be followed for 6 months post vaccination
- Stage 2 Expansion Cohort: 1 IM injection. Participants in the licensed RSV vaccine arm will be followed for 12 months post-vaccination; the remainder of the participants will be followed up to 8 months post-vaccination
- Stage 2 Booster Cohort: 1 IM injection 12 months post-primary vaccination. Participants will be followed for 6 months post-booster vaccination
- Being tested
- Investigational hMPV/RSV vaccine, Investigational hMPV vaccine (monovalent), Investigational RSV vaccine (monovalent), Licensed RSV Vaccine, Placebo
- Keywords
- hMPV, RSV, respiratory syncytial virus infection, human metapneumovirus infection
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational hMPV/RSV vaccineBiological
Investigational hMPV/RSV vaccine administered intramuscularly
Investigational hMPV vaccine (monovalent)Biological
Investigational hMPV vaccine (monovalent) administered intramuscularly
Investigational RSV vaccine (monovalent)Biological
Investigational RSV vaccine (monovalent) administered intramuscularly
Licensed RSV VaccineBiological
Licensed RSV vaccine administered intramuscularly
PlaceboBiological
Placebo administered intramuscularly
Investigational RSV+hMPV vaccineBiological
Investigational RSV+hMPV vaccine administered intramuscularly
| Study group | Role | What they receive |
|---|---|---|
| Group A Stage 1 Sentinel Cohort | Experimental | 1 IM injection of investigational hMPV/RSV vaccine formulation A Receives: Biological: Investigational hMPV/RSV vaccine |
| Group B Stage 1 Sentinel Cohort | Experimental | 1 IM injection of investigational hMPV/RSV vaccine formulation B Receives: Biological: Investigational hMPV/RSV vaccine |
| Group C Stage 1 Sentinel Cohort | Placebo comparator | 1 IM injection of placebo Receives: Biological: Placebo |
| Group 1 Stage 1 Main Cohort | Experimental | 1 IM injection of investigational hMPV/RSV vaccine formulation C Receives: Biological: Investigational hMPV/RSV vaccine |
| Group 2 Stage 1 Main Cohort | Experimental | 1 IM injection of investigational hMPV/RSV vaccine formulation D Receives: Biological: Investigational hMPV/RSV vaccine |
| Group 3 Stage 1 Main Cohort | Experimental | 1 IM injection of investigational hMPV/RSV vaccine formulation E Receives: Biological: Investigational hMPV/RSV vaccine |
| Group 4 Stage 1 Main Cohort | Experimental | 1 IM injection of investigational hMPV/RSV vaccine formulation F Receives: Biological: Investigational hMPV/RSV vaccine |
| Group 5 Stage 1 Main Cohort | Experimental | 1 IM injection of investigational hMPV/RSV vaccine formulation G Receives: Biological: Investigational hMPV/RSV vaccine |
| Group 6 Stage 1 Main Cohort | Experimental | 1 IM injection of investigational hMPV/RSV vaccine formulation A Receives: Biological: Investigational hMPV/RSV vaccine |
| Group 7 Stage 1 Main Cohort | Experimental | 1 IM injection of investigational hMPV/RSV vaccine formulation B Receives: Biological: Investigational hMPV/RSV vaccine |
| Group 8 Stage 1 Main Cohort | Experimental | 1 IM injection of investigational hMPV/RSV vaccine formulation H Receives: Biological: Investigational hMPV/RSV vaccine |
| Group 9 Stage 1 Main Cohort | Experimental | 1 IM injection of investigational hMPV/RSV vaccine formulation I Receives: Biological: Investigational hMPV/RSV vaccine |
| Group 10 Stage 1 Main Cohort | Experimental | 1 IM injection of investigational hMPV/RSV vaccine formulation J Receives: Biological: Investigational hMPV/RSV vaccine |
| Group 11 Stage 1 Main Cohort | Placebo comparator | 1 IM injection of placebo Receives: Biological: Placebo |
| Group X Stage 2 Expansion Cohort | Experimental | 1 IM injection of selected investigational hMPV/RSV vaccine formulation from Group 1-9 of Stage 1 Main Cohort Receives: Biological: Investigational hMPV/RSV vaccine |
| Group 12 Stage 2 Expansion Cohort | Experimental | 1 IM injection of investigational RSV monovalent vaccine Receives: Biological: Investigational RSV vaccine (monovalent) |
| Group 13 Stage 2 Expansion Cohort | Experimental | 1 IM injection of investigational hMPV monovalent vaccine Receives: Biological: Investigational hMPV vaccine (monovalent) |
| Group 14 Stage 2 Expansion Cohort | Experimental | 1 IM injection of licensed RSV vaccine Receives: Biological: Licensed RSV Vaccine |
| Group 15 Stage 2 Booster Cohort | Experimental | 1 IM injection of investigational RSV + hMPV vaccine formulation administered to participants from Group 14 of Expansion Cohort Receives: Biological: Investigational hMPV/RSV vaccine; Biological: Investigational RSV+hMPV vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of unsolicited immediate systemic adverse events (AEs) (Stage 1 and Stage 2 Expansion and Booster Cohorts)
Number of participants reporting immediate unsolicited systemic AEs
Measured: Within 30 minutes after primary and booster vaccinations
Presence of solicited injection site and systemic reactions (Stage 1 and Stage 2 Expansion and Booster Cohorts)
Number of participants reporting solicited injection site and systemic reactions
Measured: Up to 7 days after primary and booster vaccinations
Presence of unsolicited AEs (Stage 1 and Stage 2 Expansion and Booster Cohorts)
Number of participants reporting unsolicited AEs
Measured: Up to 28 days after primary and booster vaccinations
Presence of medically attended AEs (MAAEs) (Stage 1 and Stage 2 Expansion and Booster Cohorts)
Number of participants reporting MAAEs
Measured: Up to 6 months after primary and booster vaccinations
Presence of serious AEs (SAEs) and AEs of special interest (AESIs) (Stage 1 and Stage 2 Expansion and Booster Cohorts)
Number of participants reporting SAEs and AESIs
Measured: Up to 6 months after primary and booster vaccinations
Presence of related SAEs, related AESIs, and fatal SAEs (regardless of causality) (Stage 1 and Stage 2 Expansion and Booster Cohorts)
Number of participants reporting related SAEs, related AESIs, and fatal SAEs
Measured: Throughout the duration of the study (up to approximately 24 months)
Presence of out-of-range biological test results (Stage 1)
Number of participants with out-of-range biological tests
Measured: Up to 7 days after primary vaccination
Presence of out-of-range biological test results (Stage 2 Booster Cohort)
Number of participants with out-of-range biological tests
Measured: Up to 7 days after booster vaccination
hMPV A serum neutralizing antibodies (nAb) titers in Stage 1 Sentinel and Main Cohorts
nAb titers expressed as geometric mean titers (GMTs)
Measured: At pre-vaccination (Day 01) and 28 days post-primary vaccination (Day 29)
hMPV B serum neutralizing antibodies (nAb) titers in Stage 1 Sentinel and Main Cohorts
nAb titers expressed as geometric mean titers (GMTs)
Measured: At pre-vaccination (Day 01) and 28 days post-primary vaccination (Day 29)
RSV A serum nAb titers in Stage 1 Sentinel and Main Cohorts
nAb titers expressed as geometric mean titers (GMTs)
Measured: At pre vaccination (D01) and 28 days post-primary vaccination (D29)
RSV B serum nAb titers in Stage 1 Sentinel and Main Cohorts
nAb titers expressed as geometric mean titers (GMTs)
Measured: At pre vaccination (D01) and 28 days post-primary vaccination (D29)
hMPV A serum neutralizing antibodies (nAb) titers in Stage 2 Expansion Chort
nAb titers expressed as geometric mean titers (GMTs)
Measured: At (Day 01) pre-vaccination and 28 days after the injection of the hMPV/RSV vaccine candidate (Day 29)
hMPV B serum neutralizing antibodies (nAb) titers in Stage 2 Expansion Chort
nAb titers expressed as geometric mean titers (GMTs)
Measured: At (Day 01) pre-vaccination and 28 days after the injection of the hMPV/RSV vaccine candidate (Day 29)
RSV A serum neutralizing antibodies (nAb) titers in Stage 2 Expansion Chort
nAb titers expressed as geometric mean titers (GMTs)
Measured: At (Day 01) pre-vaccination and 28 days after the injection of the hMPV/RSV vaccine candidate (Day 29)
RSV B serum neutralizing antibodies (nAb) titers in Stage 2 Expansion Chort
nAb titers expressed as geometric mean titers (GMTs)
Measured: At (Day 01) pre-vaccination and 28 days after the injection of the hMPV/RSV vaccine candidate (Day 29)
hMPV A serum neutralizing antibodies (nAb) titers in Stage 2 Expansion Chort
nAb titers expressed as geometric mean titers (GMTs)
Measured: At (Day 01) pre-vaccination and 28 days after the injection of the hMPV standalone vaccine (Day 29)
hMPV B serum neutralizing antibodies (nAb) titers in Stage 2 Expansion Chort
nAb titers expressed as geometric mean titers (GMTs)
Measured: At (Day 01) pre-vaccination and 28 days after the injection of the hMPV standalone vaccine (Day 29)
RSV A serum neutralizing antibodies (nAb) titers in Stage 2 Expansion Chort
nAb titers expressed as geometric mean titers (GMTs)
Measured: At (Day 01) pre-vaccination and 28 days after the injection of the RSV standalone vaccine (Day 29)
RSV B serum neutralizing antibodies (nAb) titers in Stage 2 Expansion Chort
nAb titers expressed as geometric mean titers (GMTs)
Measured: At (Day 01) pre-vaccination and 28 days after the injection of the RSV standalone vaccine (Day 29)
Secondary outcomes (8)
hMPV serum anti-F immunoglobulin G (IgG) antibody (Ab) titers (Stage 1)
Ab titers expressed as geometric mean titers (GMTs)
Measured: At pre-vaccination (Day 01) and 28 days (D29) post-primary vaccination
RSV serum anti-F IgG Ab titers (Stage 1)
Ab titers expressed as geometric mean titers (GMTs)
Measured: At pre-vaccination (Day 01) and 28 days (D29) post-primary vaccination
hMPV A serum nAb titers (Stage 2 Expansion Cohort)
Ab titers expressed as geometric mean titers (GMTs)
Measured: At pre-vaccination (Day 01), 28 days (D29), and 3 and 6 months post-primary vaccination
hMPV B serum nAb titers (Stage 2 Expansion Cohort)
Ab titers expressed as geometric mean titers (GMTs)
Measured: At pre-vaccination (Day 01), 28 days (D29), and 3 and 6 months post-primary vaccination
hMPV A serum anti-F IgG Ab titers (Stage 2 Expansion Cohort)
Ab titers expressed as geometric mean titers (GMTs)
Measured: At pre-vaccination (Day 01), 28 days (D29), and 3 and 6 months post-primary vaccination
RSV A serum nAb titers (Stage 2 Expansion Cohort)
Ab titers expressed as geometric mean titers (GMTs)
Measured: At pre-vaccination (Day 01), 28 days (D29), and 3 and 6 months post-primary vaccination
RSV B serum nAb titers (Stage 2 Expansion Cohort)
Ab titers expressed as geometric mean titers (GMTs)
Measured: At pre-vaccination (Day 01), 28 days (D29), and 3 and 6 months post-primary vaccination
RSV serum anti-F IgG Ab titers (Stage 2 Expansion Cohort)
Ab titers expressed as geometric mean titers (GMTs)
Measured: At pre-vaccination (Day 01), 28 days (D29), and 3 and 6 months post-primary vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start11 Nov 2024
- Primary completion18 Jan 2027 (estimated)
- Study completion18 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Metapneumovirus ImmunizationStudies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Dose-ranging, parallel, multi-center, placebo-controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,530 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06686654
- Sponsor's protocol ID
- VBD00009
- Other IDs
- U1111-1310-4940
- Status last verified
- Dec 2025
- First submitted
- 11 Nov 2024
- Last updated
- 11 Dec 2025
- 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Randomized, Observer-blind, Placebo-controlled Multi-arm Study to Evaluate the Safety and Immunogenicity of an hMPV/RSV mRNA Vaccine Candidate in Adult Participants Aged 60 Years and Older
- ClinicalTrials.gov ID
- NCT06686654
- Acronym / sponsor ID
- VBD00009
- Keywords
- hMPV, RSV, respiratory syncytial virus infection, human metapneumovirus infection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,530 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 18 Jan 2027 (estimated)
- Study completion
- 18 Jan 2027 (estimated)
- First posted
- 13 Nov 2024 (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 aim of this study is to evaluate the safety and immunogenicity of a human metapneumovirus (hMPV) / respiratory syncytial virus (RSV) mRNA vaccine candidate encapsulated in a lipid nanoparticle (LNP) based formulation (hereafter referred to as hMPV/RSV vaccine) for the prevention of lower respiratory tract disease (LRTD) caused by hMPV and/or RSV among adults aged 60 years and older.
The study will also evaluate the safety and immunogenicity of a booster vaccination using a bivalent hMPV/RSV mRNA vaccine candidate (hereafter referred to as RSV+hMPV mRNA vaccine candidate).
Overall, the study is designed to address the following goals:
- Assess the safety profile of the candidate formulations.
- Describe the immunogenicity profile of the candidate formulations.
- Select the vaccine formulations (dose) for future development.
- Assess the safety and immunogenicity of a booster vaccination with the RSV + hMPV mRNA vaccine candidate administered 12 months after primary vaccination with a licensed RSV vaccine.
The study duration is as follows:
-Six months each for the Sentinel and Main Cohorts; up to 12 months for the Expansion Cohort, and 6 additional months for the Booster Cohort
Treatment duration:
- Stage 1 Sentinel Cohort: 1 intra-muscular (IM) injection. Participants will be followed for 6 months post vaccination
- Stage 1 Main Cohort: 1 IM injection. Participants will be followed for 6 months post vaccination
- Stage 2 Expansion Cohort: 1 IM injection. Participants in the licensed RSV vaccine arm will be followed for 12 months post-vaccination; the remainder of the participants will be followed up to 8 months post-vaccination
- Stage 2 Booster Cohort: 1 IM injection 12 months post-primary vaccination. Participants will be followed for 6 months post-booster vaccination
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 19
- Model description
- Dose-ranging, parallel, multi-center, placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| Group A Stage 1 Sentinel Cohort | Experimental | Biological: Investigational hMPV/RSV vaccine1 IM injection of investigational hMPV/RSV vaccine formulation A |
| Group B Stage 1 Sentinel Cohort | Experimental | Biological: Investigational hMPV/RSV vaccine1 IM injection of investigational hMPV/RSV vaccine formulation B |
| Group C Stage 1 Sentinel Cohort | Placebo comparator | Biological: Placebo1 IM injection of placebo |
| Group 1 Stage 1 Main Cohort | Experimental | Biological: Investigational hMPV/RSV vaccine1 IM injection of investigational hMPV/RSV vaccine formulation C |
| Group 2 Stage 1 Main Cohort | Experimental | Biological: Investigational hMPV/RSV vaccine1 IM injection of investigational hMPV/RSV vaccine formulation D |
| Group 3 Stage 1 Main Cohort | Experimental | Biological: Investigational hMPV/RSV vaccine1 IM injection of investigational hMPV/RSV vaccine formulation E |
| Group 4 Stage 1 Main Cohort | Experimental | Biological: Investigational hMPV/RSV vaccine1 IM injection of investigational hMPV/RSV vaccine formulation F |
| Group 5 Stage 1 Main Cohort | Experimental | Biological: Investigational hMPV/RSV vaccine1 IM injection of investigational hMPV/RSV vaccine formulation G |
| Group 6 Stage 1 Main Cohort | Experimental | Biological: Investigational hMPV/RSV vaccine1 IM injection of investigational hMPV/RSV vaccine formulation A |
| Group 7 Stage 1 Main Cohort | Experimental | Biological: Investigational hMPV/RSV vaccine1 IM injection of investigational hMPV/RSV vaccine formulation B |
| Group 8 Stage 1 Main Cohort | Experimental | Biological: Investigational hMPV/RSV vaccine1 IM injection of investigational hMPV/RSV vaccine formulation H |
| Group 9 Stage 1 Main Cohort | Experimental | Biological: Investigational hMPV/RSV vaccine1 IM injection of investigational hMPV/RSV vaccine formulation I |
| Group 10 Stage 1 Main Cohort | Experimental | Biological: Investigational hMPV/RSV vaccine1 IM injection of investigational hMPV/RSV vaccine formulation J |
| Group 11 Stage 1 Main Cohort | Placebo comparator | Biological: Placebo1 IM injection of placebo |
| Group X Stage 2 Expansion Cohort | Experimental | Biological: Investigational hMPV/RSV vaccine1 IM injection of selected investigational hMPV/RSV vaccine formulation from Group 1-9 of Stage 1 Main Cohort |
| Group 12 Stage 2 Expansion Cohort | Experimental | Biological: Investigational RSV vaccine (monovalent)1 IM injection of investigational RSV monovalent vaccine |
| Group 13 Stage 2 Expansion Cohort | Experimental | Biological: Investigational hMPV vaccine (monovalent)1 IM injection of investigational hMPV monovalent vaccine |
| Group 14 Stage 2 Expansion Cohort | Experimental | Biological: Licensed RSV Vaccine1 IM injection of licensed RSV vaccine |
| Group 15 Stage 2 Booster Cohort | Experimental | Biological: Investigational hMPV/RSV vaccine, Biological: Investigational RSV+hMPV vaccine1 IM injection of investigational RSV + hMPV vaccine formulation administered to participants from Group 14 of Expansion Cohort |
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
- A female participant is eligible to participate if she is not pregnant or breastfeeding and is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year or surgically sterile
Key exclusion criteria (14 listed)
- Any screening laboratory parameter with laboratory abnormality > Grade 1 deemed clinically significant by the investigator
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months). Of note, persons living with stable human immunodeficiency virus (HIV) are not excluded
- Known systemic hypersensitivity to any of the study intervention components (eg, polyethylene glycol, polysorbate); history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances; any allergic reaction (eg, anaphylaxis) after administration of an mRNA vaccine
- History of RSV and/or hMPV-associated illness, diagnosed serologically or microbiologically in the last 12 months
- Previous history of myocarditis, pericarditis, and/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 |
|---|---|---|
| Investigational hMPV/RSV vaccineInvestigational hMPV/RSV vaccine administered intramuscularly | Biological | Group 1 Stage 1 Main Cohort, Group 10 Stage 1 Main Cohort, Group 15 Stage 2 Booster Cohort, Group 2 Stage 1 Main Cohort, Group 3 Stage 1 Main Cohort, Group 4 Stage 1 Main Cohort, Group 5 Stage 1 Main Cohort, Group 6 Stage 1 Main Cohort, Group 7 Stage 1 Main Cohort, Group 8 Stage 1 Main Cohort, Group 9 Stage 1 Main Cohort, Group A Stage 1 Sentinel Cohort, Group B Stage 1 Sentinel Cohort, Group X Stage 2 Expansion Cohort |
| Investigational hMPV vaccine (monovalent)Investigational hMPV vaccine (monovalent) administered intramuscularly | Biological | Group 13 Stage 2 Expansion Cohort |
| Investigational RSV vaccine (monovalent)Investigational RSV vaccine (monovalent) administered intramuscularly | Biological | Group 12 Stage 2 Expansion Cohort |
| Licensed RSV VaccineLicensed RSV vaccine administered intramuscularly | Biological | Group 14 Stage 2 Expansion Cohort |
| PlaceboPlacebo administered intramuscularly | Biological | Group 11 Stage 1 Main Cohort, Group C Stage 1 Sentinel Cohort |
| Investigational RSV+hMPV vaccineInvestigational RSV+hMPV vaccine administered intramuscularly | Biological | Group 15 Stage 2 Booster Cohort |
Primary outcome
Presence of unsolicited immediate systemic adverse events (AEs) (Stage 1 and Stage 2 Expansion and Booster Cohorts)
Time frame: Within 30 minutes after primary and booster vaccinations
Number of participants reporting immediate unsolicited systemic AEs
Presence of solicited injection site and systemic reactions (Stage 1 and Stage 2 Expansion and Booster Cohorts)
Time frame: Up to 7 days after primary and booster vaccinations
Number of participants reporting solicited injection site and systemic reactions
Presence of unsolicited AEs (Stage 1 and Stage 2 Expansion and Booster Cohorts)
Time frame: Up to 28 days after primary and booster vaccinations
Number of participants reporting unsolicited AEs
Presence of medically attended AEs (MAAEs) (Stage 1 and Stage 2 Expansion and Booster Cohorts)
Time frame: Up to 6 months after primary and booster vaccinations
Number of participants reporting MAAEs
Presence of serious AEs (SAEs) and AEs of special interest (AESIs) (Stage 1 and Stage 2 Expansion and Booster Cohorts)
Time frame: Up to 6 months after primary and booster vaccinations
Number of participants reporting SAEs and AESIs
Presence of related SAEs, related AESIs, and fatal SAEs (regardless of causality) (Stage 1 and Stage 2 Expansion and Booster Cohorts)
Time frame: Throughout the duration of the study (up to approximately 24 months)
Number of participants reporting related SAEs, related AESIs, and fatal SAEs
Presence of out-of-range biological test results (Stage 1)
Time frame: Up to 7 days after primary vaccination
Number of participants with out-of-range biological tests
Presence of out-of-range biological test results (Stage 2 Booster Cohort)
Time frame: Up to 7 days after booster vaccination
Number of participants with out-of-range biological tests
hMPV A serum neutralizing antibodies (nAb) titers in Stage 1 Sentinel and Main Cohorts
Time frame: At pre-vaccination (Day 01) and 28 days post-primary vaccination (Day 29)
nAb titers expressed as geometric mean titers (GMTs)
hMPV B serum neutralizing antibodies (nAb) titers in Stage 1 Sentinel and Main Cohorts
Time frame: At pre-vaccination (Day 01) and 28 days post-primary vaccination (Day 29)
nAb titers expressed as geometric mean titers (GMTs)
RSV A serum nAb titers in Stage 1 Sentinel and Main Cohorts
Time frame: At pre vaccination (D01) and 28 days post-primary vaccination (D29)
nAb titers expressed as geometric mean titers (GMTs)
RSV B serum nAb titers in Stage 1 Sentinel and Main Cohorts
Time frame: At pre vaccination (D01) and 28 days post-primary vaccination (D29)
nAb titers expressed as geometric mean titers (GMTs)
hMPV A serum neutralizing antibodies (nAb) titers in Stage 2 Expansion Chort
Time frame: At (Day 01) pre-vaccination and 28 days after the injection of the hMPV/RSV vaccine candidate (Day 29)
nAb titers expressed as geometric mean titers (GMTs)
hMPV B serum neutralizing antibodies (nAb) titers in Stage 2 Expansion Chort
Time frame: At (Day 01) pre-vaccination and 28 days after the injection of the hMPV/RSV vaccine candidate (Day 29)
nAb titers expressed as geometric mean titers (GMTs)
RSV A serum neutralizing antibodies (nAb) titers in Stage 2 Expansion Chort
Time frame: At (Day 01) pre-vaccination and 28 days after the injection of the hMPV/RSV vaccine candidate (Day 29)
nAb titers expressed as geometric mean titers (GMTs)
RSV B serum neutralizing antibodies (nAb) titers in Stage 2 Expansion Chort
Time frame: At (Day 01) pre-vaccination and 28 days after the injection of the hMPV/RSV vaccine candidate (Day 29)
nAb titers expressed as geometric mean titers (GMTs)
hMPV A serum neutralizing antibodies (nAb) titers in Stage 2 Expansion Chort
Time frame: At (Day 01) pre-vaccination and 28 days after the injection of the hMPV standalone vaccine (Day 29)
nAb titers expressed as geometric mean titers (GMTs)
hMPV B serum neutralizing antibodies (nAb) titers in Stage 2 Expansion Chort
Time frame: At (Day 01) pre-vaccination and 28 days after the injection of the hMPV standalone vaccine (Day 29)
nAb titers expressed as geometric mean titers (GMTs)
RSV A serum neutralizing antibodies (nAb) titers in Stage 2 Expansion Chort
Time frame: At (Day 01) pre-vaccination and 28 days after the injection of the RSV standalone vaccine (Day 29)
nAb titers expressed as geometric mean titers (GMTs)
RSV B serum neutralizing antibodies (nAb) titers in Stage 2 Expansion Chort
Time frame: At (Day 01) pre-vaccination and 28 days after the injection of the RSV standalone vaccine (Day 29)
nAb titers expressed as geometric mean titers (GMTs)
8 secondary outcomes
hMPV serum anti-F immunoglobulin G (IgG) antibody (Ab) titers (Stage 1)
Time frame: At pre-vaccination (Day 01) and 28 days (D29) post-primary vaccination
RSV serum anti-F IgG Ab titers (Stage 1)
Time frame: At pre-vaccination (Day 01) and 28 days (D29) post-primary vaccination
hMPV A serum nAb titers (Stage 2 Expansion Cohort)
Time frame: At pre-vaccination (Day 01), 28 days (D29), and 3 and 6 months post-primary vaccination
hMPV B serum nAb titers (Stage 2 Expansion Cohort)
Time frame: At pre-vaccination (Day 01), 28 days (D29), and 3 and 6 months post-primary vaccination
hMPV A serum anti-F IgG Ab titers (Stage 2 Expansion Cohort)
Time frame: At pre-vaccination (Day 01), 28 days (D29), and 3 and 6 months post-primary vaccination
RSV A serum nAb titers (Stage 2 Expansion Cohort)
Time frame: At pre-vaccination (Day 01), 28 days (D29), and 3 and 6 months post-primary vaccination
RSV B serum nAb titers (Stage 2 Expansion Cohort)
Time frame: At pre-vaccination (Day 01), 28 days (D29), and 3 and 6 months post-primary vaccination
RSV serum anti-F IgG Ab titers (Stage 2 Expansion Cohort)
Time frame: At pre-vaccination (Day 01), 28 days (D29), and 3 and 6 months post-primary 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 11 Dec 2025.
- VBD00009 Plain Language Results SummaryLink 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Investigational hMPV/RSV vaccine, Investigational hMPV vaccine (monovalent) and Investigational RSV vaccine (monovalent) in people with Human Metapneumovirus Immunization and Respiratory Syncytial Virus Immunization, run by Sanofi Pasteur, a Sanofi Company at 24 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 14 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: under way, not looking for participants, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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?
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?
Presence of unsolicited immediate systemic adverse events (AEs) (Stage 1 and Stage 2 Expansion and Booster Cohorts) (time frame: Within 30 minutes after primary and booster vaccinations). The study lists 20 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 11 Dec 2025.