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
NCT ID: NCT06686654
Last Updated: 2025-12-11
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
1530 participants
INTERVENTIONAL
2024-11-11
2027-01-18
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Stage 2 Expansion Cohort: observer-blind until all participants complete the Month 6 visit, then open-label Stage 2 Booster Cohort: open-label
Study Groups
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Group A Stage 1 Sentinel Cohort
1 IM injection of investigational hMPV/RSV vaccine formulation A
Investigational hMPV/RSV vaccine
Investigational hMPV/RSV vaccine administered intramuscularly
Group B Stage 1 Sentinel Cohort
1 IM injection of investigational hMPV/RSV vaccine formulation B
Investigational hMPV/RSV vaccine
Investigational hMPV/RSV vaccine administered intramuscularly
Group C Stage 1 Sentinel Cohort
1 IM injection of placebo
Placebo
Placebo administered intramuscularly
Group 1 Stage 1 Main Cohort
1 IM injection of investigational hMPV/RSV vaccine formulation C
Investigational hMPV/RSV vaccine
Investigational hMPV/RSV vaccine administered intramuscularly
Group 2 Stage 1 Main Cohort
1 IM injection of investigational hMPV/RSV vaccine formulation D
Investigational hMPV/RSV vaccine
Investigational hMPV/RSV vaccine administered intramuscularly
Group 3 Stage 1 Main Cohort
1 IM injection of investigational hMPV/RSV vaccine formulation E
Investigational hMPV/RSV vaccine
Investigational hMPV/RSV vaccine administered intramuscularly
Group 4 Stage 1 Main Cohort
1 IM injection of investigational hMPV/RSV vaccine formulation F
Investigational hMPV/RSV vaccine
Investigational hMPV/RSV vaccine administered intramuscularly
Group 5 Stage 1 Main Cohort
1 IM injection of investigational hMPV/RSV vaccine formulation G
Investigational hMPV/RSV vaccine
Investigational hMPV/RSV vaccine administered intramuscularly
Group 6 Stage 1 Main Cohort
1 IM injection of investigational hMPV/RSV vaccine formulation A
Investigational hMPV/RSV vaccine
Investigational hMPV/RSV vaccine administered intramuscularly
Group 7 Stage 1 Main Cohort
1 IM injection of investigational hMPV/RSV vaccine formulation B
Investigational hMPV/RSV vaccine
Investigational hMPV/RSV vaccine administered intramuscularly
Group 8 Stage 1 Main Cohort
1 IM injection of investigational hMPV/RSV vaccine formulation H
Investigational hMPV/RSV vaccine
Investigational hMPV/RSV vaccine administered intramuscularly
Group 9 Stage 1 Main Cohort
1 IM injection of investigational hMPV/RSV vaccine formulation I
Investigational hMPV/RSV vaccine
Investigational hMPV/RSV vaccine administered intramuscularly
Group 10 Stage 1 Main Cohort
1 IM injection of investigational hMPV/RSV vaccine formulation J
Investigational hMPV/RSV vaccine
Investigational hMPV/RSV vaccine administered intramuscularly
Group 11 Stage 1 Main Cohort
1 IM injection of placebo
Placebo
Placebo administered intramuscularly
Group X Stage 2 Expansion Cohort
1 IM injection of selected investigational hMPV/RSV vaccine formulation from Group 1-9 of Stage 1 Main Cohort
Investigational hMPV/RSV vaccine
Investigational hMPV/RSV vaccine administered intramuscularly
Group 12 Stage 2 Expansion Cohort
1 IM injection of investigational RSV monovalent vaccine
Investigational RSV vaccine (monovalent)
Investigational RSV vaccine (monovalent) administered intramuscularly
Group 13 Stage 2 Expansion Cohort
1 IM injection of investigational hMPV monovalent vaccine
Investigational hMPV vaccine (monovalent)
Investigational hMPV vaccine (monovalent) administered intramuscularly
Group 14 Stage 2 Expansion Cohort
1 IM injection of licensed RSV vaccine
Licensed RSV Vaccine
Licensed RSV vaccine administered intramuscularly
Group 15 Stage 2 Booster Cohort
1 IM injection of investigational RSV + hMPV vaccine formulation administered to participants from Group 14 of Expansion Cohort
Investigational hMPV/RSV vaccine
Investigational hMPV/RSV vaccine administered intramuscularly
Investigational RSV+hMPV vaccine
Investigational RSV+hMPV vaccine administered intramuscularly
Interventions
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Investigational hMPV/RSV vaccine
Investigational hMPV/RSV vaccine administered intramuscularly
Investigational hMPV vaccine (monovalent)
Investigational hMPV vaccine (monovalent) administered intramuscularly
Investigational RSV vaccine (monovalent)
Investigational RSV vaccine (monovalent) administered intramuscularly
Licensed RSV Vaccine
Licensed RSV vaccine administered intramuscularly
Placebo
Placebo administered intramuscularly
Investigational RSV+hMPV vaccine
Investigational RSV+hMPV vaccine administered intramuscularly
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. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year or surgically sterile
Exclusion Criteria
* 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
* 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.
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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Velocity Clinical Research, Phoenix- Site Number : 8400025
Phoenix, Arizona, United States
CenExel CNS-Garden Grove- Site Number : 8400017
Garden Grove, California, United States
National Research Institute - Gardena- Site Number : 8400005
Gardena, California, United States
National Research Institute - Huntington Park- Site Number : 8400014
Huntington Park, California, United States
Velocity Clinical Research - San Diego- Site Number : 8400008
La Mesa, California, United States
Velocity Clinical Research Los Angeles- Site Number : 8400013
Los Angeles, California, United States
National Research Institute - Panorama City- Site Number : 8400012
Los Angeles, California, United States
Providence Clinical Research - North Hollywood- Site Number : 8400018
North Hollywood, California, United States
Peninsula Research Associates- Site Number : 8400002
Rolling Hills Estates, California, United States
Velocity Clinical Research - Denver- Site Number : 8400016
Englewood, Colorado, United States
Velocity Clinical Research - Washington DC- Site Number : 8400007
Washington D.C., District of Columbia, United States
Velocity Clinical Research - Hallandale Beach- Site Number : 8400022
Hallandale, Florida, United States
Suncoast Research Associates - Miami - Sunset Drive- Site Number : 8400001
Miami, Florida, United States
Velocity Clinical Research - Meridian- Site Number : 8400003
Meridian, Idaho, United States
Velocity Clinical Research - Kansas City- Site Number : 8400015
Overland Park, Kansas, United States
Velocity Clinical Research - Rockville- Site Number : 8400011
Rockville, Maryland, United States
Velocity Clinical Research - Lincoln - Valley Road- Site Number : 8400023
Lincoln, Nebraska, United States
Velocity Clinical Research - Omaha- Site Number : 8400006
Omaha, Nebraska, United States
Velocity Clinical Research - Springdale- Site Number : 8400004
Cincinnati, Ohio, United States
Velocity Clinical Research - Medford- Site Number : 8400024
Medford, Oregon, United States
Velocity Clinical Research - Austin- Site Number : 8400020
Cedar Park, Texas, United States
Velocity Clinical Research - Salt Lake City- Site Number : 8400010
West Jordan, Utah, United States
Velocity Clinical Research - Hampton- Site Number : 8400026
Hampton, Virginia, United States
Velocity Clinical Research - Seattle- Site Number : 8400019
Seattle, Washington, United States
Countries
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Related Links
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VBD00009 Plain Language Results Summary
Other Identifiers
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U1111-1310-4940
Identifier Type: OTHER
Identifier Source: secondary_id
VBD00009
Identifier Type: -
Identifier Source: org_study_id
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