New RSV vaccine shows promise for seniors in korea
NCT ID NCT06593587
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.
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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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378 people
The number who actually took part.
- Started
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Oct 2024
- Finished
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Feb 2025
- 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 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: 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
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Ajou University Hospital
Suwon, Kyǒnggi-do, 16499, South Korea
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Chonnam National University Hospital
Gwangju, Kwangju-kwangyǒkshi, 61469, South Korea
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Dong-A University Hospital
Busan, Pusan-kwangyǒkshi, 49201, South Korea
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Ewha Womans University Mokdong Hospital
Seoul, Seoul-teukbyeolsi [seoul], 07985, South Korea
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Hallym University Kangdong Sacred Heart Hospital
Seoul, Seoul-teukbyeolsi [seoul], 05355, South Korea
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Hallym University Kangnam Sacred Heart Hospital
Seoul, Seoul-teukbyeolsi [seoul], 07441, South Korea
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Inha University Hospital
Incheon, Incheon-gwangyeoksi [incheon], 22332, South Korea
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Jeonbuk National University Hospital
Jeonju, Jeonrabugdo, 54907, South Korea
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Korea University Ansan Hospital
Ansan-si, Kyǒnggi-do, 15355, South Korea
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Korea University Guro Hospital
Seoul, Seoul-teukbyeolsi [seoul], 08308, South Korea
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Kyungpook National University Hospital
Daegu, Taegu-kwangyǒkshi, 41944, South Korea
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Samsung Medical Center
Seoul, Seoul-teukbyeolsi [seoul], 06351, South Korea
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Severance Hospital, Yonsei University Health System
Seoul, Seoul-teukbyeolsi [seoul], 03722, South Korea
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Soon Chun Hyang University Bucheon Hospital
Bucheon-si, Kyǒnggi-do, 14584, South Korea
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The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, Seoul-teukbyeolsi [seoul], 06591, South Korea
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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.
- One shot, two viruses: vaccine aims to shield older adults from RSV and HMPV
- Can an mRNA vaccine shield the most vulnerable from RSV?
- Can an mRNA vaccine shield vulnerable children from RSV?
- Could a vaccine given during pregnancy shield infants from a deadly virus?
- Moderna's mRNA vaccine cocktail passes early safety check
- Could a shot during pregnancy shield babies from RSV?