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New RSV vaccine shows promise for seniors in major trial

NCT ID NCT04732871

Vaccine Sponsor: GlaxoSmithKline 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 15, 2026 · Updated 2 times

Summary

This study tests an experimental RSV vaccine in adults aged 60 and older. The goal is to see how well the vaccine triggers the immune system, how safe it is, and how long protection lasts—up to 5 years. About 1,720 participants will receive one or more doses of the vaccine at different schedules.

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

1,720 people

The number who actually took part.

Started

Feb 2021

Expected to finish

Feb 2027

An estimate. End dates often move.

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: * Male or female participants ≥60 YOA at first vaccination, who live in the community (CD participants) or in a Long-term care facility (LTCF participants). * Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol. * Written or witnessed informed consent obtained from the participant prior to performance of any study specific procedure. * Participants who are medically stable in the opinion of the investigator at the time of first vaccination. Patients 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 by the investigator as medically stable. Exclusion Criteria: Medical conditions * Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine. * Hypersensitivity to latex. * Serious or unstable chronic illness. * Recurrent or un-controlled 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. * Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study. * Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe. * Any history of dementia or any medical condition that moderately or severely impairs cognition. Prior/Concomitant therapy * Use of any investigational or non-registered product other than the study vaccine during the period beginning 30 days before the first dose of study vaccine, or planned use during the study period. * Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before each dose and ending 30 days after each dose of study vaccine administration, with the exception of inactivated, split virion and subunit influenza vaccines which can be administered up to 14 days before or from 14 days after each study vaccination. * Previous vaccination with an RSV vaccine. * Administration of long-acting immune-modifying drugs or planned administration at any time during the study period. * Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the first dose of study vaccine or planned administration during the study period. * Chronic administration (defined as more than 14 consecutive days in total) of immunosuppressants or other immune-modifying drugs during the period starting 90 days prior to the first vaccine dose or planned administration during the study period. For corticosteroids, this will mean prednisone \>=20 mg/day, or equivalent. Inhaled and topical steroids are allowed. 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. Other exclusions * 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 participation in the trial until the study end. This includes: * Planned move during the study period to another LTCF that will prohibit participation in the trial until study end. * Planned move from the community to a LTCF that will prohibit participation in the trial until study end. * Participation of any study personnel or their immediate dependants, family, or household members.

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Conditions

The condition(s) this trial relates to.

respiratory syncytial virus infectious disease prevention target

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

    Mobile, Alabama, 36608, United States

  • GSK Investigational Site

    Phoenix, Arizona, 85020, United States

  • GSK Investigational Site

    Riverside, California, 92503, United States

  • GSK Investigational Site

    San Diego, California, 92103, United States

  • GSK Investigational Site

    Coral Gables, Florida, 33134, United States

  • GSK Investigational Site

    Fort Myers, Florida, 33912, United States

  • GSK Investigational Site

    Sarasota, Florida, 34243, United States

  • GSK Investigational Site

    The Villages, Florida, 32162, United States

  • GSK Investigational Site

    Evansville, Indiana, 47714, United States

  • GSK Investigational Site

    Wichita, Kansas, 67226, United States

  • GSK Investigational Site

    Richfield, Minnesota, 55423, United States

  • GSK Investigational Site

    Kansas City, Missouri, 64114, United States

  • GSK Investigational Site

    Rochester, New York, 14609, United States

  • GSK Investigational Site

    Mt. Pleasant, South Carolina, 29464, United States

  • GSK Investigational Site

    Spartanburg, South Carolina, 29303, United States

  • GSK Investigational Site

    San Antonio, Texas, 78229, United States

  • GSK Investigational Site

    Norfolk, Virginia, 23502, United States

  • GSK Investigational Site

    Wenatchee, Washington, 98801, United States

  • GSK Investigational Site

    Espoo, 02230, Finland

  • GSK Investigational Site

    Helsinki, 00100, Finland

  • GSK Investigational Site

    Helsinki, 00930, Finland

  • GSK Investigational Site

    Jarvenpaa, 04400, Finland

  • GSK Investigational Site

    Kokkola, 67100, Finland

  • GSK Investigational Site

    Oulu, 90220, Finland

  • GSK Investigational Site

    Pori, 28100, Finland

  • GSK Investigational Site

    Seinäjoki, 60100, Finland

  • GSK Investigational Site

    Tampere, 33100, Finland

  • GSK Investigational Site

    Turku, 20520, Finland

  • GSK Investigational Site

    Essen, 45355, Germany

  • GSK Investigational Site

    Essen, 45359, Germany

  • GSK Investigational Site

    Goch, 47574, Germany

  • GSK Investigational Site

    Hamburg, 20095, Germany

  • GSK Investigational Site

    Mainz, 55116, Germany

  • GSK Investigational Site

    München, 80339, Germany

  • GSK Investigational Site

    Wallerfing, 94574, Germany

  • GSK Investigational Site

    Würzburg, 97074, Germany

  • GSK Investigational Site

    Fukuoka, 812-0025, Japan

  • GSK Investigational Site

    Kumamoto, 861-4157, Japan

  • GSK Investigational Site

    Tokyo, 160-0017, Japan

  • GSK Investigational Site

    Changhua, 500, Taiwan

  • GSK Investigational Site

    Taichung, 40447, Taiwan

  • GSK Investigational Site

    Taichung, 407, Taiwan

  • GSK Investigational Site

    Taipei, 100, Taiwan

  • GSK Investigational Site

    Taipei, 104, Taiwan

  • GSK Investigational Site

    Taipei, 112, Taiwan

  • GSK Investigational Site

    Taoyuan, 333, Taiwan

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