New RSV vaccine study targets those over 80
NCT ID NCT07203365
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at how well the approved RSV vaccine Arexvy works in people aged 80 and older compared to those aged 60-65. Researchers will measure immune responses and side effects. The goal is to see if the vaccine protects the oldest and frailest adults as effectively as younger seniors.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 65 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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May 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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: * Male or female individuals who were born between 1965 and 1960 or 1945 and before, at the time of the first vaccination, who live in the community or in a long-term care facility. * Individuals who can understand and read Swedish. * Individuals who can provide written consent and agree (by written consent) to receive the Arexvy vaccine. * Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * Participants who are medically stable in the opinion of the investigator at the time of first vaccination. * Participants with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease, are allowed to participate if considered by the investigator as medically stable. Exclusion Criteria: * Individuals who are medically immunocompromised, less than 2 years since hematopoietic stem cell transplantation (HSCT) or graft-versus-host disease (GVHD), solid-organ transplanted, using immunosuppressive drugs for treatment of cancer and who have inflammatory mediated or autoimmune conditions, as judged by the Investigator. * Individuals who have already received an RSV vaccine dose at any time in the past. * Any known or suspected reaction, hypersensitivity or allergies to be exacerbated by any product or component included in the vaccine and trial. * Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of participation in the trial. * Treatment or disease which, according to the investigator, can affect treatment or trial results. * Any of the following medical conditions: Unstable chronic illness, Recurrent or un-controlled neurological disorders or seizures, Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study, Any other medical condition that in the judgment of the investigator would make intramuscular injection unsafe, Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study, Any history of dementia or any medical condition that moderately or severely impairs cognition and understanding of the informed consent form and/or study procedures, History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures. * Participation in another clinical trial during the study period, or any previous clinical trials with RSV- or hMPV-vaccine or other prophylaxis. * Planned move during the study period that will prohibit participating in the study until study end. * Participation of any study personnel or their immediate dependents, family or household members as well as any family relations to Sponsor or PI. * Co-administration of other vaccines less than 14 days before or after study vaccination. A period of less than 30 days before or after study vaccination applies in the case of Shingrix.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Akademiskt specialistcentrum Studieenheten
RECRUITINGStockholm, 113 61, Sweden
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Familjeläkarna SÄBO
RECRUITINGSaltsjöbaden, 13334, Sweden
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