Study of a Respiratory Syncytial Virus/Human Metapneumovirus Vaccine Candidate
NCT ID: NCT06134648
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
646 participants
INTERVENTIONAL
2023-11-01
2026-03-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
QUADRUPLE
* Investigators, laboratory personnel, and participants will be blinded
* Sponsor study staff and study staff preparing/administering the study interventions will be unblinded
Study Groups
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Sentinel Cohort: RSV/hMPV Group 0 (Dose L)
Participants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate
RSV/hMPV vaccine candidate Dose L
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
Sentinel Cohort: RSV/hMPV Group 1 (Dose A)
Participants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate
RSV/hMPV vaccine candidate Dose A
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
Sentinel Cohort: RSV/hMPV Group 2 (Dose B)
Participants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate
RSV/hMPV vaccine candidate Dose B
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
Sentinel Cohort: Placebo-Group 3
Participants will be randomized to receive a single IM injection of placebo
Placebo
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
Main Cohort: RSV/hMPV Group 1 (Dose A)
Participants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate
RSV/hMPV vaccine candidate Dose A
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
Main Cohort: RSV/hMPV Group 2 (Dose B)
Participants will be randomized to receive a single IM injection of RSV/hMPV vaccine candidate
RSV/hMPV vaccine candidate Dose B
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
Main Cohort: Placebo-Group 3
Participants will be randomized to receive a single IM injection of placebo
Placebo
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
Booster Cohort-RSV/hMPV
Participants will be randomized to receive a determined dose of single IM injection of RSV/hMPV vaccine candidate from a subset of Main cohort
RSV/hMPV vaccine candidate Dose A
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
RSV/hMPV vaccine candidate Dose B
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
Booster Cohort-Placebo
Participants will be randomized to receive of single IM injection of placebo from a subset of Main cohort
Placebo
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
Interventions
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RSV/hMPV vaccine candidate Dose L
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
RSV/hMPV vaccine candidate Dose A
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
RSV/hMPV vaccine candidate Dose B
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
Placebo
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular Injection
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
* 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.
60 Years
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Locations
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Collaborative Neuroscience Research Site Number : 8400017
Los Alamitos, California, United States
Matrix Clinical Research Site Number : 8400011
Los Angeles, California, United States
Peninsula Research Associates Site Number : 8400001
Rolling Hills Estates, California, United States
Suncoast Research Associates, LLC Site Number : 8400002
Miami, Florida, United States
AMR Chicago, Oakbrook Terrace Site Number : 8400019
Oakbrook Terrace, Illinois, United States
Velocity Clinical Research, Sioux City Site Number : 8400012
Sioux City, Iowa, United States
AMR Lexington Site Number : 8400008
Lexington, Kentucky, United States
AMR Kansas City Site Number : 8400014
Kansas City, Missouri, United States
AMR Knoxville Site Number : 8400010
Knoxville, Tennessee, United States
DM Clinical Research - Tomball Site Number : 8400004
Tomball, Texas, United States
Investigational Site Number : 6300002
Guayama, , Puerto Rico
Investigational Site Number : 6300001
San Juan, , Puerto Rico
Investigational Site Number : 6300003
San Juan, , Puerto Rico
Countries
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Related Links
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VBD00003 Plain Language Results Summaries
Other Identifiers
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U1111-1287-8547
Identifier Type: REGISTRY
Identifier Source: secondary_id
VBD00003
Identifier Type: -
Identifier Source: org_study_id
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