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New RSV vaccine shows promise for seniors in korea

NCT ID NCT06593587

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested an RSV vaccine in 378 older adults (60+) in Korea to see if it is safe and helps the body fight the virus. Participants received either the vaccine or a placebo and were monitored for side effects and immune response. The results showed the vaccine was well tolerated and boosted antibody levels against RSV.

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

378 people

The number who actually took part.

Started

Oct 2024

Finished

Feb 2025

Lead sponsor

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

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: 1. Participants 60 years of age or older at Visit 1 * Male participants able to father children must agree to use a highly effective method of contraception from the time of informed consent through at least 28 days after study intervention administration * Female participants must not be of childbearing potential 2. Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study. Healthy participants with preexisting 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. 3. Participants who are willing and able to comply with all scheduled visits, investigational plan, laboratory tests, frequent symptom assessment by mobile device application (e-diary), and other study procedures. 4. Participants who are ambulatory and live in the community, or in assisted-living or long-term care residential facilities that provide minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living (ADL). 5. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent document (ICD) and the protocol. Exclusion Criteria: 1. A confirmed diagnosis of RSV infection ≤180 days before study intervention administration. 2. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular (IM) injection. 3. Prior history of any subtype of Guillain-Barré syndrome (GBS) of any etiology. 4. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s) or any related vaccine. 5. Serious chronic disorder, including metastatic malignancy, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the participant from participating in the study. 6. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination. 7. Any medical or psychiatric condition, including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality, that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. 8. Individuals who receive chronic systemic treatment with immunosuppressive therapy (other than systemic corticosteroids meeting the criteria noted below), including cytotoxic agents, immunosuppressive monoclonal antibodies, or radiotherapy, eg, for cancer or an autoimmune disease, from 60 days before study intervention administration or planned receipt throughout the study. * Receipt of systemic corticosteroids (≥20 mg/day of prednisone or equivalent) for ≥14 days from 28 days before study intervention. * Inhaled/nebulized, intra articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted. 9. Receipt of blood/plasma products or immunoglobulin within 60 days before study intervention administration. 10. Previous vaccination with any licensed or investigational RSV vaccine, or planned receipt throughout the study. 11. Previous administration with an investigational product (drug or vaccine) within 6 months prior to study intervention administration. Participation in other studies involving an investigational product (drug or vaccine) at any time during participation in this study. 12. Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members. \-

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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

  • Ajou University Hospital

    Suwon, Kyǒnggi-do, 16499, South Korea

  • Chonnam National University Hospital

    Gwangju, Kwangju-kwangyǒkshi, 61469, South Korea

  • Dong-A University Hospital

    Busan, Pusan-kwangyǒkshi, 49201, South Korea

  • Ewha Womans University Mokdong Hospital

    Seoul, Seoul-teukbyeolsi [seoul], 07985, South Korea

  • Hallym University Kangdong Sacred Heart Hospital

    Seoul, Seoul-teukbyeolsi [seoul], 05355, South Korea

  • Hallym University Kangnam Sacred Heart Hospital

    Seoul, Seoul-teukbyeolsi [seoul], 07441, South Korea

  • Inha University Hospital

    Incheon, Incheon-gwangyeoksi [incheon], 22332, South Korea

  • Jeonbuk National University Hospital

    Jeonju, Jeonrabugdo, 54907, South Korea

  • Korea University Ansan Hospital

    Ansan-si, Kyǒnggi-do, 15355, South Korea

  • Korea University Guro Hospital

    Seoul, Seoul-teukbyeolsi [seoul], 08308, South Korea

  • Kyungpook National University Hospital

    Daegu, Taegu-kwangyǒkshi, 41944, South Korea

  • Samsung Medical Center

    Seoul, Seoul-teukbyeolsi [seoul], 06351, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul-teukbyeolsi [seoul], 03722, South Korea

  • Soon Chun Hyang University Bucheon Hospital

    Bucheon-si, Kyǒnggi-do, 14584, South Korea

  • The Catholic Univ. of Korea Seoul St. Mary's Hospital

    Seoul, Seoul-teukbyeolsi [seoul], 06591, South Korea

  • The Catholic University Of Korea St. Vincent's Hospital

    Suwon, Kyǒnggi-do, 16247, South Korea

More trials for these conditions

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