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Can a new RSV vaccine keep adults out of the hospital? 690,000 join trial

NCT ID NCT06684743

Vaccine Sponsor: Tor Biering-Sørensen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This massive study is testing whether the Abrysvo RSV vaccine can prevent hospitalizations due to RSV in adults aged 18 and older. Half of the 690,000 participants will receive the vaccine, while the other half will not. Researchers will track how many in each group end up hospitalized for RSV-related illness.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Abrysvo (RSV prefusion F protein-based vaccine)
What this could lead to
If successful, this could show that the Abrysvo vaccine effectively reduces RSV-related hospitalizations in a broad adult population, including younger adults.
What could go wrong
This is a pragmatic trial with no blinding, so results may be influenced by participant behavior. The vaccine's effectiveness may vary by age and health status, and rare side effects may only emerge in such a large study.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 690,000 people

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

Started

Nov 2024

Expected to finish

Aug 2028

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

18 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 * Age 18 years and above * Informed consent form has been signed and dated Exclusion Criteria: * There are no specific exclusion criteria for this study

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Conditions

The condition(s) this trial relates to.

respiratory system disorder respiratory syncytial virus infectious disease prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

RSV

Contacts and locations

Locations

  • Center for Translational Cardiology and Pragmatic Randomized Trials Department of Cardiology Copenhagen University Hospital - Herlev and Gentofte

    Copenhagen, 2900, Denmark

  • Danske Lægers Vaccinations Service

    Søborg, 2860, Denmark

  • General Public Health Directorate of Galician Health Service

    Santiago de Compostela, A Coruña, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.