New combo vaccine targets two respiratory viruses in seniors
NCT ID NCT06134648
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new vaccine designed to protect against two respiratory viruses: RSV and hMPV. It involved 646 healthy adults aged 60 and older who received either the vaccine or a placebo. The goal was to see if the vaccine is safe and triggers a strong immune response, with some participants getting a booster shot after 12 months.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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646 people
The number who actually took part.
- Started
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Nov 2023
- Finished
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Feb 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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60 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: 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 * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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AMR Chicago, Oakbrook Terrace Site Number : 8400019
Oakbrook Terrace, Illinois, 60181, United States
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AMR Kansas City Site Number : 8400014
Kansas City, Missouri, 64114, United States
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AMR Knoxville Site Number : 8400010
Knoxville, Tennessee, 37919, United States
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AMR Lexington Site Number : 8400008
Lexington, Kentucky, 40509, United States
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Collaborative Neuroscience Research Site Number : 8400017
Los Alamitos, California, 90720, United States
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DM Clinical Research - Tomball Site Number : 8400004
Tomball, Texas, 77375, United States
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Investigational Site Number : 6300001
San Juan, 00909, Puerto Rico
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Investigational Site Number : 6300002
Guayama, 000784, Puerto Rico
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Investigational Site Number : 6300003
San Juan, 00918, Puerto Rico
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Matrix Clinical Research Site Number : 8400011
Los Angeles, California, 90057, United States
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Peninsula Research Associates Site Number : 8400001
Rolling Hills Estates, California, 90274, United States
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Suncoast Research Associates, LLC Site Number : 8400002
Miami, Florida, 33173, United States
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Velocity Clinical Research, Sioux City Site Number : 8400012
Sioux City, Iowa, 51106, United States
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