RSV vaccine shows promise for High-Risk younger adults

NCT ID NCT06389487

Vaccine Sponsor: GlaxoSmithKline Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an experimental RSV vaccine in about 1,500 adults. It compared the immune response and safety in younger adults (18-49 years) who are at increased risk for RSV disease to older adults (60 years and older). The goal was to see if the vaccine works as well in the younger high-risk group.

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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

1,459 people

The number who actually took part.

Started

Apr 2024

Finished

Mar 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

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: * Participants and/or participant's parent(s)/ Legally acceptable representative (LAR) who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiary, attend study site visits, ability to access and utilize a phone or other electronic communications). * Written or witnessed informed consent obtained from the participant/participant's parent(s)/LAR(s) (participant must be able to understand the informed consent) prior to performance of any study-specific procedure. Written informed assent obtained from the participant (participant must be able to understand the informed assent) if he/she is less than the legal age prior to performance of any study-specific procedure. Specific inclusion criteria for all participants in Cohort 1 and Cohort 3 (RSV-A-AIR Group) • A male or female participant 18-49 YOA at the time of the study intervention administration. * Participants should be diagnosed with at least 1 of the following medical conditions if considered medically stable by the investigator: * Chronic cardiopulmonary disease resulting in activity restricting symptoms or use of long term medication: o Chronic obstructive pulmonary disease (COPD) o Asthma o Cystic fibrosis o Other chronic respiratory diseases: lung fibrosis, restrictive lung disease, interstitial lung disease, emphysema or bronchiectasis o Chronic heart failure: o Pre-existing Coronary Artery Disease (CAD) (CAD not otherwise specified) * Cardiac arrhythmia * Diabetes mellitus: types 1 or 2 with active treatment for the past 6 months * Other diseases at increased risk for RSV disease: * Chronic kidney disease * Chronic moderate to severe liver disease * Neurologic or neuromuscular conditions * Female participants of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as premenarche, hysterectomy, bilateral oophorectomy, bilateral salpingectomy or post-menopause. * Female participants of childbearing potential may be enrolled in the study, if the participant: * has practiced adequate contraception from 1 month prior to study intervention administration, and * has a negative pregnancy test on the day of study prior to intervention administration, and * has agreed to continue adequate contraception for at least 1 month after completion of the study intervention administration. Specific inclusion criteria for all participants in Cohort 2 (RSV-OA Group): • A male or female participant \>=60 YOA at the time of the study intervention administration. Participants with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease are allowed to participate in this study if considered medically stable by the investigator. • Participants living in the general community or in an assisted-living facility that provides minimal assistance, such that the participant is primarily responsible for self-care and activities of daily living. Exclusion Criteria: Medical conditions * Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., current malignancy, human immunodeficiency virus) or immunosuppressive/cytotoxic therapy (e.g., medication used during cancer chemotherapy, organ transplantation, or to treat autoimmune disorders), based on medical history and physical examination (no laboratory testing required). * History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention. * Unstable chronic illness. * Any history of dementia or any medical condition that moderately or severely impairs cognition. * Recurrent or uncontrolled neurological disorders or seizures. Participants with medically controlled active or chronic neurological diseases can be enrolled in the study as per investigator assessment, provided that their condition will allow them to comply with the requirements of the protocol (e.g., completion of the diary cards, attend study site visits). Study participants may decide to assign a caregiver to help them complete the study procedures. * Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study (e.g., life-threatening disease). * Any 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. Prior/Concomitant therapy * Use of any investigational or non-registered product (drug, vaccine, or medical device) other than the study intervention during the period beginning 30 days before the dose of study intervention (Day -29 to Day 1), or planned use during the study period (up to Visit 3, Month 6). * Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after the dose of study intervention administration, with the exception of inactivated, subunit and split influenza vaccines or COVID-19 vaccines which can be administered up to 14 days before or from 14 days after the study intervention administration. * Previous vaccination with any RSV vaccine, including investigational RSV vaccines. * Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or administration of long-acting immune-modifying treatments or planned administration at any time up to the End-of-study (EOS). * Up to 3 months prior to the study intervention administration: * For corticosteroids, this will mean prednisone \>=20 mg/day, or equivalent. Inhaled, topical and intra-articular steroids are allowed * Administration of immunoglobulins and/or any blood products or plasma derivatives * Up to 6 months prior to study intervention administration: long-acting immune-modifying drugs including among others immunotherapy (e.g., Tumor Necrosis Factor (TNF)-inhibitors), monoclonal antibodies, antitumoral medication. Prior/Concurrent clinical study experience • Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product (drug or invasive medical device). Other exclusions: Other exclusions for all participants: * 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. * Bedridden participants. * 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. Other exclusions for Cohort 1 and Cohort 3: * Pregnant or lactating female participant. * Female planning to become pregnant or planning to discontinue contraceptive precautions within 1 month after study intervention administration.

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Conditions

The condition(s) this trial relates to.

respiratory syncytial virus infectious disease

As listed by the trial registrant

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

Respiratory syncytial virus infections

Contacts and locations

Locations

GSK Investigational Site

Glendale, Arizona, 85308, United States
GSK Investigational Site

Phoenix, Arizona, 85284, United States
GSK Investigational Site

North Hollywood, California, 91606-3287, United States
GSK Investigational Site

Oakland, California, 94610, United States
GSK Investigational Site

Walnut Creek, California, 94598, United States
GSK Investigational Site

Hialeah, Florida, 33012, United States
GSK Investigational Site

North Miami, Florida, 33173, United States
GSK Investigational Site

Orlando, Florida, 32806, United States
GSK Investigational Site

Lexington, Kentucky, 40509, United States
GSK Investigational Site

Silver Spring, Maryland, 20904, United States
GSK Investigational Site

Rochester, New York, 14609, United States
GSK Investigational Site

Oklahoma City, Oklahoma, 73111, United States
GSK Investigational Site

Knoxville, Tennessee, 37909, United States
GSK Investigational Site

DeSoto, Texas, 75115, United States
GSK Investigational Site

Charlottesville, Virginia, 22911, United States
GSK Investigational Site

Wenatchee, Washington, 98801, United States
GSK Investigational Site

Coffs Harbour, New South Wales, 2450, Australia
GSK Investigational Site

Sydney, New South Wales, 2010, Australia
GSK Investigational Site

Sydney, New South Wales, 2065, Australia
GSK Investigational Site

Fortitude Valley, Queensland, 4006, Australia
GSK Investigational Site

Tarragindi, Queensland, 4121, Australia
GSK Investigational Site

Melbourne, Victoria, 3051, Australia
GSK Investigational Site

St Albans, Victoria, 3021, Australia
GSK Investigational Site

New Westminster, British Columbia, V3L 3W4, Canada
GSK Investigational Site

Victoria, British Columbia, V8V 4A1, Canada
GSK Investigational Site

Truro, Nova Scotia, B2N 1L2, Canada
GSK Investigational Site

Greater Sudbury, Ontario, P3C 1X3, Canada
GSK Investigational Site

Guelph, Ontario, N1G 0B4, Canada
GSK Investigational Site

London-Ontario, Ontario, N5W 6A2, Canada
GSK Investigational Site

Toronto, Ontario, M4G 3E8, Canada
GSK Investigational Site

Québec, Quebec, G1N 4V3, Canada
GSK Investigational Site

Québec, Quebec, G1V 4G2, Canada
GSK Investigational Site

Québec, Quebec, G1V 4W2, Canada
GSK Investigational Site

Saint-Charles-Borromée, Quebec, J6E 2B4, Canada
GSK Investigational Site

Sherbrooke, Quebec, J1J 2G2, Canada
GSK Investigational Site

Weinheim, Baden-Wurttemberg, 69469, Germany
GSK Investigational Site

Berlin, 10117, Germany
GSK Investigational Site

Berlin, 10787, Germany
GSK Investigational Site

Berlin, 13347, Germany
GSK Investigational Site

Essen, 45355, Germany
GSK Investigational Site

Mainz, 55116, Germany
GSK Investigational Site

Wallerfing, 94574, Germany
GSK Investigational Site

Witten, 58455, Germany
GSK Investigational Site

Würzburg, 97070, Germany
GSK Investigational Site

Ibaraki, 300-0062, Japan
GSK Investigational Site

Kanagawa, 211-0041, Japan
GSK Investigational Site

Tokyo, 155-0031, Japan
GSK Investigational Site

Tokyo, 180-0022, Japan
GSK Investigational Site

Cape Town, 7530, South Africa
GSK Investigational Site

Cape Town, 7700, South Africa
GSK Investigational Site

Johannesburg, 2113, South Africa
GSK Investigational Site

Reiger Park, 1459, South Africa

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