Respiratory Syncytial Virus InfectionPhase 1/2NCT06134648
Study of a Respiratory Syncytial Virus/Human Metapneumovirus Vaccine Candidate
A Phase 1/2 study testing RSV/hMPV vaccine candidate Dose L, RSV/hMPV vaccine candidate Dose A and RSV/hMPV vaccine candidate Dose B in people with Respiratory Syncytial Virus Infection and Healthy Volunteers, run by Sanofi Pasteur, a Sanofi Company at 13 sites in 2 countries.
Trial summary
The purpose of this study is to assess the safety and immunogenicity of a single intramuscular (IM) injection of different doses of an respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) vaccine candidate, in adult participants aged 60 years and older. 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 Infection, Healthy Volunteers, Human Metapneumovirus
- What is being tested?
- RSV/hMPV vaccine candidate Dose L, RSV/hMPV vaccine candidate Dose A and RSV/hMPV vaccine candidate Dose B
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 646 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 1 Nov 2023to 27 Feb 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- Participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion Note: Participants with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included.
Who cannot join
- Participants are excluded from the study if any of the following criteria apply:
- Any screening laboratory parameter with laboratory abnormalities deemed clinically significant by the investigator
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy. 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 mRNA coronavirus disease 2019 (COVID-19) vaccine
- History of RSV and/or hMPV-associated illness, diagnosed clinically, serologically, or microbiologically in the last 12 months
- Previous history of myocarditis, pericarditis, and/or myopericarditis
Show all 17Show fewer
- 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
- Thrombocytopenia or bleeding disorder, contraindicating intramuscular (IM) injection based on investigator's judgment
- Receipt of anticoagulants in the 3 weeks preceding inclusion
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
- Alcohol, prescription drug, or substance abuse that, in the opinion of the investigator, might interfere with the study conduct or completion
- History of acute infection symptoms or a positive severe acute respiratory syndrome coronavirus reverse transcription polymerase chain reaction (SARS-CoV-2 RT-PCR) or antigen test in the 10 days prior to the visit. A prospective participant should not be included in the study until the condition has resolved
- Receipt of any vaccine other than mRNA vaccine in the 4 weeks preceding any study intervention administration or planned receipt of any vaccine other than mRNA vaccine in the 4 weeks 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
- Participation at the time of study enrollment (or in the 4 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States10 sites
AMR Kansas City Site Number : 8400014
Kansas City, Missouri, 64114
AMR Knoxville Site Number : 8400010
Knoxville, Tennessee, 37919
AMR Lexington Site Number : 8400008
Lexington, Kentucky, 40509
Collaborative Neuroscience Research Site Number : 8400017
Los Alamitos, California, 90720
Matrix Clinical Research Site Number : 8400011
Los Angeles, California, 90057
Suncoast Research Associates, LLC Site Number : 8400002
Miami, Florida, 33173
AMR Chicago, Oakbrook Terrace Site Number : 8400019
Oakbrook Terrace, Illinois, 60181
Peninsula Research Associates Site Number : 8400001
Rolling Hills Estates, California, 90274
Velocity Clinical Research, Sioux City Site Number : 8400012
Sioux City, Iowa, 51106
DM Clinical Research - Tomball Site Number : 8400004
Tomball, Texas, 77375
Puerto Rico3 sites
Investigational Site Number : 6300002
Guayama, 000784
Investigational Site Number : 6300001
San Juan, 00909
Investigational Site Number : 6300003
San Juan, 00918
About this study
Official title: A Phase I/IIa, Randomized, Observer-blind Placebo-controlled Multi-arm Study to Evaluate the Safety and Immunogenicity of an RSV/hMPV Vaccine, in Adult Participants Aged 60 Years and Older
The purpose of this study is to assess the safety and immunogenicity of a single intramuscular (IM) injection of different doses of an respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) vaccine candidate, in adult participants aged 60 years and older. In addition, the study will evaluate the safety and immunogenicity of a booster vaccination administered 12 months after the primary vaccination in a subset of the study population.
Read the detailed description
Study duration per participant:
12 months for the Sentinel and Main Cohorts and 24 months overall for the subset of participants enrolled in the Booster Cohort.
Treatment Duration:
Sentinel Cohort: 1 IM injection. Participants will be followed for 12 months post-vaccination.
Main Cohort: 1 IM injection. Participants will be followed for 12 months post-vaccination.
Booster Cohort: 1 IM injection 12 months after the primary vaccination (Main Cohort). Participants will be followed for 12 months after administration of the booster dose.
- Being tested
- RSV/hMPV vaccine candidate Dose L, RSV/hMPV vaccine candidate Dose A, RSV/hMPV vaccine candidate Dose B, Placebo
- 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.
RSV/hMPV vaccine candidate Dose LBiological
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
RSV/hMPV vaccine candidate Dose ABiological
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
RSV/hMPV vaccine candidate Dose BBiological
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
PlaceboBiological
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
| Study group | Role | What they receive |
|---|---|---|
| Sentinel Cohort: RSV/hMPV Group 0 (Dose L) | Experimental | Participants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate Receives: Biological: RSV/hMPV vaccine candidate Dose L |
| Sentinel Cohort: RSV/hMPV Group 1 (Dose A) | Experimental | Participants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate Receives: Biological: RSV/hMPV vaccine candidate Dose A |
| Sentinel Cohort: RSV/hMPV Group 2 (Dose B) | Experimental | Participants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate Receives: Biological: RSV/hMPV vaccine candidate Dose B |
| Sentinel Cohort: Placebo-Group 3 | Placebo comparator | Participants will be randomized to receive a single IM injection of placebo Receives: Biological: Placebo |
| Main Cohort: RSV/hMPV Group 1 (Dose A) | Experimental | Participants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate Receives: Biological: RSV/hMPV vaccine candidate Dose A |
| Main Cohort: RSV/hMPV Group 2 (Dose B) | Experimental | Participants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate Receives: Biological: RSV/hMPV vaccine candidate Dose B |
| Main Cohort: Placebo-Group 3 | Placebo comparator | Participants will be randomized to receive a single IM injection of placebo Receives: Biological: Placebo |
| Booster Cohort-RSV/hMPV | Experimental | Participants will be randomized to receive a determined dose of single IM injection of RSV/hMPV vaccine candidate from a subset of Main cohort Receives: Biological: RSV/hMPV vaccine candidate Dose A; Biological: RSV/hMPV vaccine candidate Dose B |
| Booster Cohort-Placebo | Placebo comparator | Participants will be randomized to receive of single IM injection of placebo from a subset of Main cohort Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of unsolicited systemic immediate adverse events (AEs)
Number of participants experiencing immediate an immediate unsolicited systemic adverse event
Measured: Within 30 minutes after primary vaccination
Presence of solicited injection site or systemic reactions
Number of participants reporting:
- injection site reactions: pain, erythema and swelling
- systemic reactions: fever, headache, fatigue, myalgia, arthralgia and chills
Measured: Within 7 days after primary vaccination
Presence of unsolicited AEs
Number of participants experiencing unsolicited AEs
Measured: Within 28 days after vaccination
Presence of medically attended adverse events (MAAEs)
Number of participants experiencing MAAEs
Measured: Up to 6 months after primary injection
Presence of serious adverse events (SAEs)
Number of participants experiencing SAEs
Measured: Up to 6 months after primary injection
Presence of adverse events of special interest (AESIs)
Number of participants experiencing AESIs
Measured: Up to 6 months after primary injection
Presence of related SAEs
Number of participants experiencing related SAEs
Measured: Throughout study (approximately 24 months)
Presence of related AESIs
Number of participants experiencing related AESIs
Measured: Throughout study (approximately 24 months)
Presence of fatal SAEs
Number of participants experiencing fatal SAEs
Measured: Throughout study (approximately 24 months)
Presence of out-of-range biological test results
Number of participants with biological safety assessment values out of normal range (as per the laboratory performing the test, including shift from baseline values)
Measured: Within 7 days after vaccination
RSV-A serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post- primary vaccination (D29) in Phase IIa (Main/Booster Cohort)
RSV-A serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post- primary vaccination (D29)
Measured: Day 1 and Day 29
hMPV serum nAb titers at pre-vaccination (D01), 28 days post-primary vaccination (D29) in Phase IIa (Main/Booster Cohort)
hMPV serum nAb titers at pre-vaccination (D01), 28 days post-primary vaccination (D29)
Measured: Day 1 and Day 29
Secondary outcomes (13)
RSV-A serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post-primary vaccination (D29)
RSV-A serum nAb titers at pre-vaccination (D01), 28 days (D29) post-primary vaccination
Measured: Day 1 and Day 29
RSV-B serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post-primary vaccination (D29)
RSV-B serum nAb titers at pre-vaccination (D01), 28 days (D29) post-primary vaccination
Measured: Day 1 and Day 29
hMPV serum nAb titers at pre vaccination (D01), 28 days post-primary vaccination (D29)
hMPV serum nAb titers at pre-vaccination (D01), 28 days (D29) post-primary vaccination
Measured: Day 1 and Day 29
RSV A serum nAb titers at pre-vaccination (D01), 28 days (D29), 3, 6, 9 and 12 months post-primary vaccination
RSV A serum nAb titers at pre-vaccination (D01), 28 days (D29), 3, 6, 9 and 12 months post-primary vaccination
Measured: Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12
RSV B serum nAb titers at pre-vaccination (D01), 28 days (D29), 3, 6, 9 and 12 months post-primary vaccination
RSV B serum nAb titers at pre-vaccination (D01), 28 days (D29), 3, 6, 9 and 12 months post-primary vaccination
Measured: Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12
RSV A serum anti-F immunoglobulin G (IgG) antibody (Ab) titers at pre-vaccination (D01), 28 days (D29), 3, 6, 9 and 12 months post-primary vaccination
RSV A serum anti-F immunoglobulin G (IgG) antibody (Ab) titers at pre-vaccination (D01), 28 days (D29), 3, 6, 9 and 12 months post-primary vaccination
Measured: Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12
hMPV A serum nAb titers at pre vaccination (D01), 28 days (D29), 3, 6, 9 and 12 months post-primary vaccination
hMPV A serum nAb titers at pre vaccination (D01), 28 days (D29), 3, 6, 9 and 12 months post-primary vaccination
Measured: Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12
hMPV A serum anti-F IgG Ab titers at pre vaccination (D01), 28 days (D29), 3, 6, 9 and 12 months post-primary vaccination
hMPV A serum anti-F IgG Ab titers at pre vaccination (D01), 28 days (D29), 3 months (D91), and 6 months (D181) post vaccination
Measured: Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12
RSV A serum nAb titers at pre booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post-booster vaccination
RSV A serum nAb titers at pre booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post-booster vaccination
Measured: Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12
RSV B serum nAb titers at pre booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post-booster vaccination
RSV B serum nAb titers at pre booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post-booster vaccination
Measured: Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12
RSV A serum anti-F IgG Ab titers at pre-booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post- booster vaccination
RSV A serum anti-F IgG Ab titers at pre-booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post- booster vaccination
Measured: Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12
hMPV A serum nAb titers at pre booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post booster vaccination
hMPV A serum nAb titers at pre booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post-booster vaccination
Measured: Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12
hMPV serum anti-F IgG Ab titers at pre booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post booster vaccination
hMPV serum anti-F IgG Ab titers at pre booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post- booster vaccination
Measured: Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Nov 2023
- Primary completion27 Feb 2026
- Study completion27 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus InfectionStudies 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
- Sequential
- Model description
- Dose-escalation (Phase I, sentinel cohort), parallel (Phase IIa, main cohort), multi-center
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 646 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
- NCT06134648
- Sponsor's protocol ID
- VBD00003
- Other IDs
- U1111-1287-8547
- Status last verified
- Mar 2026
- First submitted
- 7 Nov 2023
- Last updated
- 12 Mar 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa, Randomized, Observer-blind Placebo-controlled Multi-arm Study to Evaluate the Safety and Immunogenicity of an RSV/hMPV Vaccine, in Adult Participants Aged 60 Years and Older
- ClinicalTrials.gov ID
- NCT06134648
- Acronym / sponsor ID
- VBD00003
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 646 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 27 Feb 2026 (actual)
- Study completion
- 27 Feb 2026 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and immunogenicity of a single intramuscular (IM) injection of different doses of an respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) vaccine candidate, in adult participants aged 60 years and older. In addition, the study will evaluate the safety and immunogenicity of a booster vaccination administered 12 months after the primary vaccination in a subset of the study population.
Detailed description
Study duration per participant:
12 months for the Sentinel and Main Cohorts and 24 months overall for the subset of participants enrolled in the Booster Cohort.
Treatment Duration:
Sentinel Cohort: 1 IM injection. Participants will be followed for 12 months post-vaccination.
Main Cohort: 1 IM injection. Participants will be followed for 12 months post-vaccination.
Booster Cohort: 1 IM injection 12 months after the primary vaccination (Main Cohort). Participants will be followed for 12 months after administration of the booster dose.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 9
- Model description
- Dose-escalation (Phase I, sentinel cohort), parallel (Phase IIa, main cohort), multi-center
| Arm | Type | Receives |
|---|---|---|
| Sentinel Cohort: RSV/hMPV Group 0 (Dose L) | Experimental | Biological: RSV/hMPV vaccine candidate Dose LParticipants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate |
| Sentinel Cohort: RSV/hMPV Group 1 (Dose A) | Experimental | Biological: RSV/hMPV vaccine candidate Dose AParticipants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate |
| Sentinel Cohort: RSV/hMPV Group 2 (Dose B) | Experimental | Biological: RSV/hMPV vaccine candidate Dose BParticipants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate |
| Sentinel Cohort: Placebo-Group 3 | Placebo comparator | Biological: PlaceboParticipants will be randomized to receive a single IM injection of placebo |
| Main Cohort: RSV/hMPV Group 1 (Dose A) | Experimental | Biological: RSV/hMPV vaccine candidate Dose AParticipants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate |
| Main Cohort: RSV/hMPV Group 2 (Dose B) | Experimental | Biological: RSV/hMPV vaccine candidate Dose BParticipants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate |
| Main Cohort: Placebo-Group 3 | Placebo comparator | Biological: PlaceboParticipants will be randomized to receive a single IM injection of placebo |
| Booster Cohort-RSV/hMPV | Experimental | Biological: RSV/hMPV vaccine candidate Dose A, Biological: RSV/hMPV vaccine candidate Dose BParticipants will be randomized to receive a determined dose of single IM injection of RSV/hMPV vaccine candidate from a subset of Main cohort |
| Booster Cohort-Placebo | Placebo comparator | Biological: PlaceboParticipants will be randomized to receive of single IM injection of placebo from a subset of Main cohort |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 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.
- Participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion Note: Participants with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included.
Key exclusion criteria (17 listed)
- Any screening laboratory parameter with laboratory abnormalities deemed clinically significant by the investigator
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy. 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 mRNA coronavirus disease 2019 (COVID-19) vaccine
- History of RSV and/or hMPV-associated illness, diagnosed clinically, 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 |
|---|---|---|
| RSV/hMPV vaccine candidate Dose LPharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection | Biological | Sentinel Cohort: RSV/hMPV Group 0 (Dose L) |
| RSV/hMPV vaccine candidate Dose APharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection | Biological | Booster Cohort-RSV/hMPV, Main Cohort: RSV/hMPV Group 1 (Dose A), Sentinel Cohort: RSV/hMPV Group 1 (Dose A) |
| RSV/hMPV vaccine candidate Dose BPharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection | Biological | Booster Cohort-RSV/hMPV, Main Cohort: RSV/hMPV Group 2 (Dose B), Sentinel Cohort: RSV/hMPV Group 2 (Dose B) |
| PlaceboPharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection | Biological | Booster Cohort-Placebo, Main Cohort: Placebo-Group 3, Sentinel Cohort: Placebo-Group 3 |
Primary outcome
Presence of unsolicited systemic immediate adverse events (AEs)
Time frame: Within 30 minutes after primary vaccination
Number of participants experiencing immediate an immediate unsolicited systemic adverse event
Presence of solicited injection site or systemic reactions
Time frame: Within 7 days after primary vaccination
Number of participants reporting: * injection site reactions: pain, erythema and swelling * systemic reactions: fever, headache, fatigue, myalgia, arthralgia and chills
Presence of unsolicited AEs
Time frame: Within 28 days after vaccination
Number of participants experiencing unsolicited AEs
Presence of medically attended adverse events (MAAEs)
Time frame: Up to 6 months after primary injection
Number of participants experiencing MAAEs
Presence of serious adverse events (SAEs)
Time frame: Up to 6 months after primary injection
Number of participants experiencing SAEs
Presence of adverse events of special interest (AESIs)
Time frame: Up to 6 months after primary injection
Number of participants experiencing AESIs
Presence of related SAEs
Time frame: Throughout study (approximately 24 months)
Number of participants experiencing related SAEs
Presence of related AESIs
Time frame: Throughout study (approximately 24 months)
Number of participants experiencing related AESIs
Presence of fatal SAEs
Time frame: Throughout study (approximately 24 months)
Number of participants experiencing fatal SAEs
Presence of out-of-range biological test results
Time frame: Within 7 days after vaccination
Number of participants with biological safety assessment values out of normal range (as per the laboratory performing the test, including shift from baseline values)
RSV-A serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post- primary vaccination (D29) in Phase IIa (Main/Booster Cohort)
Time frame: Day 1 and Day 29
RSV-A serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post- primary vaccination (D29)
hMPV serum nAb titers at pre-vaccination (D01), 28 days post-primary vaccination (D29) in Phase IIa (Main/Booster Cohort)
Time frame: Day 1 and Day 29
hMPV serum nAb titers at pre-vaccination (D01), 28 days post-primary vaccination (D29)
13 secondary outcomes
RSV-A serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post-primary vaccination (D29)
Time frame: Day 1 and Day 29
RSV-B serum neutralizing antibody (nAb) titers at pre-vaccination (D01) and 28 days post-primary vaccination (D29)
Time frame: Day 1 and Day 29
hMPV serum nAb titers at pre vaccination (D01), 28 days post-primary vaccination (D29)
Time frame: Day 1 and Day 29
RSV A serum nAb titers at pre-vaccination (D01), 28 days (D29), 3, 6, 9 and 12 months post-primary vaccination
Time frame: Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12
RSV B serum nAb titers at pre-vaccination (D01), 28 days (D29), 3, 6, 9 and 12 months post-primary vaccination
Time frame: Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12
RSV A serum anti-F immunoglobulin G (IgG) antibody (Ab) titers at pre-vaccination (D01), 28 days (D29), 3, 6, 9 and 12 months post-primary vaccination
Time frame: Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12
hMPV A serum nAb titers at pre vaccination (D01), 28 days (D29), 3, 6, 9 and 12 months post-primary vaccination
Time frame: Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12
hMPV A serum anti-F IgG Ab titers at pre vaccination (D01), 28 days (D29), 3, 6, 9 and 12 months post-primary vaccination
Time frame: Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12
RSV A serum nAb titers at pre booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post-booster vaccination
Time frame: Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12
RSV B serum nAb titers at pre booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post-booster vaccination
Time frame: Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12
RSV A serum anti-F IgG Ab titers at pre-booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post- booster vaccination
Time frame: Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12
hMPV A serum nAb titers at pre booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post booster vaccination
Time frame: Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12
hMPV serum anti-F IgG Ab titers at pre booster vaccination (D01), 28 days (D29), and 3, 6, 9, and 12 months post booster vaccination
Time frame: Day 1, Day 29, Month 3, Month 6, Month 9 and Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- VBD00003 Plain Language Results SummariesLink 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
Related trials for Respiratory Syncytial Virus Infection
RecruitingPhase 3
Study to Learn About a Respiratory Syncytial Virus Vaccine in Children at High Risk of RSV Disease
Respiratory Syncytial Virus (RSV)
Active, not recruitingPhase 3
A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease
Respiratory Syncytial Virus Infections
Active, not recruitingPhase 1
A Phase 1 Study to Evaluate JCXH-108, an mRNA-based Vaccine Against RSV
Respiratory Syncytial Virus (RSV), Infectious Disease
RecruitingPhase 2
Immunogenicity of RSVPreF3 Vaccine in Immunocompromised Persons
Respiratory Syncytial Virus (RSV)
RecruitingObservational study
TARSILA Real-World Evidence Study
Respiratory Syncytial Virus (RSV), Maternal Immunization
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing RSV/hMPV vaccine candidate Dose L, RSV/hMPV vaccine candidate Dose A and RSV/hMPV vaccine candidate Dose B in people with Respiratory Syncytial Virus Infection and Healthy Volunteers, run by Sanofi Pasteur, a Sanofi Company at 13 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 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Puerto Rico. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of unsolicited systemic immediate adverse events (AEs) (time frame: Within 30 minutes after primary vaccination). The study lists 12 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 12 Mar 2026.