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New RSV vaccine study targets those over 80

NCT ID NCT07203365

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 65 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

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

60 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Akademiskt specialistcentrum Studieenheten

    RECRUITING

    Stockholm, 113 61, Sweden

  • Familjeläkarna SÄBO

    RECRUITING

    Saltsjöbaden, 13334, Sweden

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