New combo vaccine aims to shield seniors from two dangerous respiratory viruses
NCT ID NCT05903183
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new vaccine called IVX-A12 that targets two respiratory viruses: RSV and hMPV. It involved 264 healthy adults aged 60 to 85. The goal was to see if the vaccine is safe and boosts the immune system to fight these viruses.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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264 people
The number who actually took part.
- Started
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May 2023
- Finished
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Oct 2024
- 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 to 85 years
- 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: 1. Male or female participants, who must be in stable health based on medical history, vital signs, physical examination, and laboratory evaluation prior to vaccination, in the investigator's clinical judgment 2. Participants may have ongoing chronic conditions (comorbidities such as hypertension, congestive heart failure, chronic obstructive pulmonary disease, type 2 diabetes mellitus, hyperlipoproteinemia, or hypothyroidism) who are, in the investigator's opinion, medically compensated and without recent exacerbation within the prior 3 months 3. Participants able to voluntarily give written informed consent and can comply with trial procedures including follow-up for approximately 12 months after vaccination 4. Body mass index 17 to less than (\<) 40 kilograms per square meter (kg/m\^2) at screening 5. Before randomization, female participants must be unable to conceive (example, menopausal, that is, 12 consecutive months without menstruation, hysterectomy, oophorectomy, etc.) and not intending to conceive by any method 6. Participants must agree not to donate blood from the time of vaccination through 3 months after vaccination 7. Participants must be willing to provide verifiable identification and have the means to be contacted and to contact the investigator or the site's staff during the entire clinical trial Exclusion Criteria: 1. Participants with moderate or severe liver disease, metastatic solid tumor, and acquired immunodeficiency syndrome (AIDS) are to be excluded. In addition, participants with underlying significant illness or condition(s) or ongoing treatment that, in the opinion of the investigator, could (i) interfere with the conduct of the trial, (ii) pose an unacceptable risk to the participant in this trial, (iii) interfere with the participant's ability to comply with the trial procedures or abide by the procedures 2. Older adults who meet frail elderly criteria (older persons with medical, nutritional, cognitive, emotional, or activity impairments, as defined by the Dalhousie Clinical Frailty Score greater than or equal to \[\>=\]4) 3. Prior receipt of any licensed or investigational RSV or hMPV vaccine within the past 12 months 4. Prior receipt of another investigational medicinal product (IMP; trial drug, biologic, or device) not authorized for use in the United States of America (USA) and European Union within the past 3 months 5. Laboratory-confirmed RSV or hMPV infection within 12 months prior to enrollment 6. Currently enrolled or plan to participate in another clinical trial with an investigational agent (including licensed or unlicensed vaccine, drug, biologic, device, blood product, or medication) to be received during the trial period 7. History of malignancy within 5 years before screening not in the following categories: (i) participants with squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix may be enrolled at the discretion of the investigator, (ii) participants with a history of malignancy within 5 years before screening, with minimal risk of recurrence per investigator's judgment, can be enrolled 8. Acute illness, with or without fever at the time of planned vaccination 9. History of hypersensitivity or serious adverse reactions to vaccines, such as anaphylaxis or angioedema, or any known allergies to any component of the IVX-121 and/or IVX-241 vaccine, or hypersensitivity to latex 10. Abnormal function of the immune system resulting from clinical conditions including chronic administration of systemic corticosteroids (oral/intravenous/IM at a daily dose equivalent of greater than (\>) 20 milligram (mg) prednisone in a period of more than 14 days), or administration of immunosuppressive chemotherapy, biologics, or radiotherapy within the past 3 months prior to planned vaccination 11. Participants who have received treatment with immunoglobulins or other biologics, such as immunosuppressive therapies expected to modify immune response to vaccination (including monoclonal antibodies \[MAbs\] for chronic underlying conditions) within the past 3 months prior to planned vaccination 12. Trial personnel as an immediate family or household member 13. For licensed vaccines: 1. Receipt of licensed inactivated vaccines (including seasonal influenza vaccine) within 14 days prior to trial vaccine administration on Day 0, or licensed replicating vaccines such as ribonucleic acid (RNA) or live-attenuated virus vaccines within 30 days prior to Day 0 2. Receipt of licensed vaccines is permitted after completion of the Day 28 visit 3. Receipt of any licensed Coronavirus Disease-2019 (COVID-19) vaccines is permitted if dosing regimen completed within 21 days prior to Day 0 or after completion of the Day 28 visit.
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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 Lexington
Lexington, Kentucky, 40509, United States
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AMR Phoenix
Tempe, Arizona, 85281, United States
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ASR, LLC
Nampa, Idaho, 83587, United States
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Cenexel RCA
Hollywood, Florida, 33024, United States
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Clinical Research Atlanta
Stockbridge, Georgia, 30281, United States
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Johnson City Clin-Trials (JCCT)
Lenexa, Kansas, 66219, United States
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PanAmerican Clinical Research
Brownsville, Texas, 78520, United States
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Rochester Clinical Research, Inc
Rochester, New York, 14609, United States
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Velocity Clinical Research
Omaha, Nebraska, 68134, United States
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Velocity Clinical Research-Boise
Meridian, Idaho, 83642, United States
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