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RSV booster study aims to keep seniors safe for five seasons

NCT ID NCT06534892

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 30, 2026 · Updated 2 times

Summary

This study looks at the best timing for a booster shot of the RSV vaccine in adults aged 60 and older. It will follow over 10,000 participants for up to 5 years to see how long protection lasts and whether a second dose is needed. The goal is to help prevent serious RSV infections in older adults.

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

10,212 people

The number who actually took part.

Started

Aug 2024

Expected to finish

Sep 2026

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 who were previously enrolled in the RSV OA=ADJ-006 study and received placebo (Placebo group) or a single dose of the RSVPreF3 OA vaccine (RSV\_1dose group). * Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, attend regular phone calls/study site visits, ability to access and utilize a phone or other electronic communications). * 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 study entry. 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. 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 study intervention. * Hypersensitivity to latex. * Serious or unstable chronic illness. * Recurrent or un-controlled neurological disorders or seizures. * Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study. * Any other 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. * Any history of dementia or any medical condition that moderately or severely impairs cognition and understanding of the informed consent form and/or study procedures. * Participants who experienced an SAE or pIMD from first study intervention administration in the RSV OA=ADJ-006 study until enrollment in this study that was considered to be possibly or probably related to the study vaccine or non-study concomitant vaccines, either by the investigator or the sponsor, including hypersensitivity reactions. * Participants with a new onset of a pIMD or exacerbation of a pIMD from first study intervention administration in the RSV OA=ADJ-006 study until enrollment in this study, that, in the opinion of the investigator, exposes the participant to unacceptable risk from subsequent vaccination. 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. • Previous vaccination with an RSV vaccine (investigational or licensed vaccine) and/or planned administration of an RSV vaccine during the study period other than the RSVPreF3 OA vaccine administered during the RSV OA=ADJ-006 study. 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 Exclusion Criteria: * 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. * Participation of any study personnel or their immediate dependents, family, or household members. * Bedridden participants. Specific exclusion criteria for Crossover group: • Planned or administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after study intervention administration, with the exception of COVID vaccines which can be administered up to 14 days before or from 14 days after study vaccination. Inactivated seasonal influenza vaccines can be co-administered or administered at any time. Specific exclusion criteria for RSV\_PreS4, RSV\_PreS5 and RSV\_1Dose groups: * Planned or administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after study intervention administration, with the exception of COVID vaccines and inactivated seasonal influenza vaccines which can be administered up to 14 days before or from 14 days after study intervention administration. * 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 study visit or planned administration during the study period. * Chronic administration of immunosuppressants or other immunemodifying drugs during the period starting 90 days prior to the first study visit or planned administration during the study period. For corticosteroids, this will mean prednisone \>= 20 mg/day, or equivalent. Inhaled and topical steroids are allowed.

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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

    Birmingham, Alabama, 35205, United States

  • GSK Investigational Site

    Birmingham, Alabama, 35211, United States

  • GSK Investigational Site

    Huntsville, Alabama, 35802, United States

  • GSK Investigational Site

    Phoenix, Arizona, 85020, United States

  • GSK Investigational Site

    Tucson, Arizona, 85741, United States

  • GSK Investigational Site

    Cerritos, California, 90703, United States

  • GSK Investigational Site

    Doral, Florida, 33172, United States

  • GSK Investigational Site

    Fort Myers, Florida, 33912, United States

  • GSK Investigational Site

    Jacksonville, Florida, 32205, United States

  • GSK Investigational Site

    Lake City, Florida, 32055, United States

  • GSK Investigational Site

    Melbourne, Florida, 32934, United States

  • GSK Investigational Site

    Miami, Florida, 33174, United States

  • GSK Investigational Site

    Orlando, Florida, 32806, United States

  • GSK Investigational Site

    Pinellas Park, Florida, 33781, United States

  • GSK Investigational Site

    The Villages, Florida, 32162, United States

  • GSK Investigational Site

    West Palm Beach, Florida, 33409, United States

  • GSK Investigational Site

    Atlanta, Georgia, 30328, United States

  • GSK Investigational Site

    Savannah, Georgia, 31406, United States

  • GSK Investigational Site

    Chicago, Illinois, 60602, United States

  • GSK Investigational Site

    Evansville, Indiana, 47714, United States

  • GSK Investigational Site

    Mishawaka, Indiana, 46544, United States

  • GSK Investigational Site

    El Dorado, Kansas, 67042, United States

  • GSK Investigational Site

    Newton, Kansas, 67114, United States

  • GSK Investigational Site

    Wichita, Kansas, 67205, United States

  • GSK Investigational Site

    Wichita, Kansas, 67226, United States

  • GSK Investigational Site

    Lexington, Kentucky, 40509, United States

  • GSK Investigational Site

    Rockville, Maryland, 20854, United States

  • GSK Investigational Site

    Richfield, Minnesota, 55423, United States

  • GSK Investigational Site

    Kansas City, Missouri, 64114, United States

  • GSK Investigational Site

    St Louis, Missouri, 63141, United States

  • GSK Investigational Site

    Omaha, Nebraska, 68134, United States

  • GSK Investigational Site

    Las Vegas, Nevada, 89113, United States

  • GSK Investigational Site

    New York, New York, 10017, United States

  • GSK Investigational Site

    Rochester, New York, 14609, United States

  • GSK Investigational Site

    Hickory, North Carolina, 28601, United States

  • GSK Investigational Site

    Mooresville, North Carolina, 28117, United States

  • GSK Investigational Site

    Rocky Mount, North Carolina, 27804, United States

  • GSK Investigational Site

    Salisbury, North Carolina, 28144, United States

  • GSK Investigational Site

    Winston-Salem, North Carolina, 27103, United States

  • GSK Investigational Site

    Centerville, Ohio, 45459, United States

  • GSK Investigational Site

    Cincinnati, Ohio, 45236, United States

  • GSK Investigational Site

    Columbus, Ohio, 43212, United States

  • GSK Investigational Site

    Erie, Pennsylvania, 16508, United States

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15236, United States

  • GSK Investigational Site

    Anderson, South Carolina, 29621, United States

  • GSK Investigational Site

    Mt. Pleasant, South Carolina, 29405, United States

  • GSK Investigational Site

    Knoxville, Tennessee, 37938, United States

  • GSK Investigational Site

    Memphis, Tennessee, 38119, United States

  • GSK Investigational Site

    Dallas, Texas, 75234, United States

  • GSK Investigational Site

    Fort Worth, Texas, 76104, United States

  • GSK Investigational Site

    Houston, Texas, 77008, United States

  • GSK Investigational Site

    Keller, Texas, 76248, United States

  • GSK Investigational Site

    San Antonio, Texas, 78229, United States

  • GSK Investigational Site

    Salt Lake City, Utah, 84106, United States

  • GSK Investigational Site

    Norfolk, Virginia, 23502, United States

  • GSK Investigational Site

    Botany, New South Wales, 2019, Australia

  • GSK Investigational Site

    Coffs Harbour, New South Wales, 2450, Australia

  • GSK Investigational Site

    Sydney, New South Wales, 2010, Australia

  • GSK Investigational Site

    Taringa, Queensland, 4068, Australia

  • GSK Investigational Site

    Tarragindi, Queensland, 4121, Australia

  • GSK Investigational Site

    Camberwell, Victoria, 3124, Australia

  • GSK Investigational Site

    Geelong, Victoria, 3220, Australia

  • GSK Investigational Site

    Spearwood, Western Australia, 6163, Australia

  • GSK Investigational Site

    Diepenbeek, 3590, Belgium

  • GSK Investigational Site

    Edegem, 2650, Belgium

  • GSK Investigational Site

    Erpent, 5101, Belgium

  • GSK Investigational Site

    Genk, 3600, Belgium

  • GSK Investigational Site

    Ghent, 9000, Belgium

  • GSK Investigational Site

    Ieper, 8900, Belgium

  • GSK Investigational Site

    Kluisbergen, 9690, Belgium

  • GSK Investigational Site

    Linkebeek, 3545, Belgium

  • GSK Investigational Site

    Linkebeek, 6534, Belgium

  • GSK Investigational Site

    Mechelen, 2800, Belgium

  • GSK Investigational Site

    Tremelo, 3120, Belgium

  • GSK Investigational Site

    Edmonton, Alberta, T5A 4L8, Canada

  • GSK Investigational Site

    New Westminster, British Columbia, V3L 3W4, Canada

  • GSK Investigational Site

    Surrey, British Columbia, V3S 2N6, Canada

  • GSK Investigational Site

    Vancouver, British Columbia, V6Z 2T1, Canada

  • GSK Investigational Site

    Victoria, British Columbia, V8V 3M9, Canada

  • GSK Investigational Site

    Victoria, British Columbia, V8V 4A1, Canada

  • GSK Investigational Site

    Halifax, Nova Scotia, B3J 3G9, Canada

  • GSK Investigational Site

    Truro, Nova Scotia, B2N 1L2, Canada

  • GSK Investigational Site

    Greater Sudbury, Ontario, P3C 1X3, Canada

  • GSK Investigational Site

    London-Ontario, Ontario, N5W 6A2, Canada

  • GSK Investigational Site

    Ottawa, Ontario, K1H 8L6, Canada

  • GSK Investigational Site

    Sarnia, Ontario, N7T 4X3, Canada

  • GSK Investigational Site

    Toronto, Ontario, M9W 4L6, Canada

  • GSK Investigational Site

    Chicoutimi, Quebec, G7H 7Y8, Canada

  • GSK Investigational Site

    Mirabel, Quebec, J7J 2K8, Canada

  • GSK Investigational Site

    Pointe-Claire, Quebec, H9R4S3, Canada

  • GSK Investigational Site

    Québec, Quebec, G1W 4R4, Canada

  • GSK Investigational Site

    Saint-Charles-Borromée, Quebec, J6E 2B4, Canada

  • GSK Investigational Site

    Sainte-Foy, Quebec, G1E 7G9, Canada

  • GSK Investigational Site

    Sherbrooke, Quebec, J1J 2G2, Canada

  • GSK Investigational Site

    Paide, 72713, Estonia

  • GSK Investigational Site

    Tallinn, 10117, Estonia

  • GSK Investigational Site

    Tallinn, 10128, Estonia

  • GSK Investigational Site

    Tallinn, 10617, Estonia

  • GSK Investigational Site

    Tallinn, 13619, Estonia

  • GSK Investigational Site

    Tartu, 50411, Estonia

  • 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

    Seinäjoki, 60100, Finland

  • GSK Investigational Site

    Tampere, 33100, Finland

  • GSK Investigational Site

    Turku, 20520, Finland

  • GSK Investigational Site

    Weinheim, Baden-Wurttemberg, 69469, Germany

  • GSK Investigational Site

    Munich, Bavaria, 80339, Germany

  • GSK Investigational Site

    Freiberg, Saxony, 09599, Germany

  • GSK Investigational Site

    Berlin, 10117, Germany

  • GSK Investigational Site

    Berlin, 12627, Germany

  • GSK Investigational Site

    Berlin, 13347, Germany

  • GSK Investigational Site

    Cologne, 51069, Germany

  • GSK Investigational Site

    Dachau, 85221, Germany

  • GSK Investigational Site

    Dippoldiswalde, 01744, Germany

  • GSK Investigational Site

    Dresden, 01279, Germany

  • GSK Investigational Site

    Essen, 45355, Germany

  • GSK Investigational Site

    Essen, 45359, Germany

  • GSK Investigational Site

    Frankfurt, 60313, Germany

  • GSK Investigational Site

    Freital, 01705, Germany

  • GSK Investigational Site

    Goch, 47574, Germany

  • GSK Investigational Site

    Hamburg, 20095, Germany

  • GSK Investigational Site

    Hanover, 30159, Germany

  • GSK Investigational Site

    Hochheim am Main, 65239, Germany

  • GSK Investigational Site

    Leipzig, 04103, Germany

  • GSK Investigational Site

    Mainz, 55116, Germany

  • GSK Investigational Site

    Schenefeld, 22869, Germany

  • GSK Investigational Site

    Wallerfing, 94574, Germany

  • GSK Investigational Site

    Wangen, 88239, Germany

  • GSK Investigational Site

    Witten, 58455, Germany

  • GSK Investigational Site

    Würzburg, 97070, Germany

  • GSK Investigational Site

    Alessandria, 15121, Italy

  • GSK Investigational Site

    Bari, 70124, Italy

  • GSK Investigational Site

    Belluno, 32100, Italy

  • GSK Investigational Site

    Ferrara, 44124, Italy

  • GSK Investigational Site

    Naples, 80131, Italy

  • GSK Investigational Site

    Negrar Verona, 37024, Italy

  • GSK Investigational Site

    Palermo, 90127, Italy

  • GSK Investigational Site

    Pessione - Chieri to, 10023, Italy

  • GSK Investigational Site

    Pisa, 56126, Italy

  • GSK Investigational Site

    Roma, 00128, Italy

  • GSK Investigational Site

    Siena, 53100, Italy

  • GSK Investigational Site

    Hiroshima, 732-0053, Japan

  • GSK Investigational Site

    Ibaraki, 306-0041, Japan

  • GSK Investigational Site

    Kumamoto, 860-0863, Japan

  • GSK Investigational Site

    Okinawa, 901-2393, Japan

  • GSK Investigational Site

    Saitama, 350-1122, Japan

  • GSK Investigational Site

    Shizuoka, 421-0193, Japan

  • GSK Investigational Site

    Tokyo, 121-0815, Japan

  • GSK Investigational Site

    Tokyo, 160-0017, Japan

  • GSK Investigational Site

    Tokyo, 165-0031, Japan

  • GSK Investigational Site

    Tokyo, 169-0072, Japan

  • GSK Investigational Site

    Yamagata, 990-0834, Japan

  • GSK Investigational Site

    Yamaguchi, 750-0061, Japan

  • GSK Investigational Site

    Chihuahua City, 31203, Mexico

  • GSK Investigational Site

    León, 37530, Mexico

  • GSK Investigational Site

    Mexico City, 06760, Mexico

  • GSK Investigational Site

    Mérida, 97070, Mexico

  • GSK Investigational Site

    Monterrey, 64460, Mexico

  • GSK Investigational Site

    Oaxaca City, 68000, Mexico

  • GSK Investigational Site

    Querétaro, 76070, Mexico

  • GSK Investigational Site

    RM Pharmamexico CITY, 03100, Mexico

  • GSK Investigational Site

    San Luis Potosí City, 78209, Mexico

  • GSK Investigational Site

    Grafton Auckland, 1010, New Zealand

  • GSK Investigational Site

    Hawke's Bay, 4122, New Zealand

  • GSK Investigational Site

    Kapiti, 5032, New Zealand

  • GSK Investigational Site

    Palmerston North, 4414, New Zealand

  • GSK Investigational Site

    Tauranga, 3110, New Zealand

  • GSK Investigational Site

    Wellington, 6021, New Zealand

  • GSK Investigational Site

    Częstochowa, 42-202, Poland

  • GSK Investigational Site

    Elblag, 82-300, Poland

  • GSK Investigational Site

    Gdansk, 80-382, Poland

  • GSK Investigational Site

    Gdynia, 81-537, Poland

  • GSK Investigational Site

    Katowice, 40-040, Poland

  • GSK Investigational Site

    Katowice, 40-282, Poland

  • GSK Investigational Site

    Katowice, 40-648, Poland

  • GSK Investigational Site

    Krakow, 31-501, Poland

  • GSK Investigational Site

    Lodz, 90-127, Poland

  • GSK Investigational Site

    Lodz, 91-363, Poland

  • GSK Investigational Site

    Poznan, 60-702, Poland

  • GSK Investigational Site

    Warsaw, 02-672, Poland

  • GSK Investigational Site

    Warsaw, 03-291, Poland

  • GSK Investigational Site

    Wroclaw, 50-088, Poland

  • GSK Investigational Site

    Wroclaw, 53-671, Poland

  • GSK Investigational Site

    Gatchina, Leningradskaya Oblast', 188300, Russia

  • GSK Investigational Site

    Barnaul, 656043, Russia

  • GSK Investigational Site

    Kemerovo, 650066, Russia

  • GSK Investigational Site

    Moscow, 115478, Russia

  • GSK Investigational Site

    Saint Petersburg, 196158, Russia

  • GSK Investigational Site

    Saint Petersburg, 197022, Russia

  • GSK Investigational Site

    StPetersburg, 191119, Russia

  • GSK Investigational Site

    StPetersburg, 196143, Russia

  • GSK Investigational Site

    Yekaterinburg, 620137, Russia

  • GSK Investigational Site

    Bloemfontein, 9300, South Africa

  • GSK Investigational Site

    Cape Town, 7700, South Africa

  • GSK Investigational Site

    Ekurhuleni, 1459, South Africa

  • GSK Investigational Site

    Johannesburg, 1818, South Africa

  • GSK Investigational Site

    Johannesburg, 2113, South Africa

  • GSK Investigational Site

    Middelburg, 1050, South Africa

  • GSK Investigational Site

    Moloto South, 1022, South Africa

  • GSK Investigational Site

    Tembisa, 1632, South Africa

  • GSK Investigational Site

    Seoul, Seoul Teugbyeolsi, 06351, South Korea

  • GSK Investigational Site

    Ansan, 15355, South Korea

  • GSK Investigational Site

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

  • GSK Investigational Site

    Daegu, 41944, South Korea

  • GSK Investigational Site

    Incheon, 400-711, South Korea

  • GSK Investigational Site

    Jeonju, 54907, South Korea

  • GSK Investigational Site

    Kangwon-do, 26426, South Korea

  • GSK Investigational Site

    Seoul, 07441, South Korea

  • GSK Investigational Site

    Seoul, 08308, South Korea

  • GSK Investigational Site

    Seoul, 135-720, South Korea

  • GSK Investigational Site

    Seoul, 137-701, South Korea

  • GSK Investigational Site

    Suwon Gyeonggi-do, 442-723, South Korea

  • GSK Investigational Site

    Alcorcón, 28922, Spain

  • GSK Investigational Site

    Barcelona, 08023, Spain

  • GSK Investigational Site

    Barcelona, 08036, Spain

  • GSK Investigational Site

    Barcelona, 08430, Spain

  • GSK Investigational Site

    Barcelona, 08500, Spain

  • GSK Investigational Site

    Barcelona, 08540, Spain

  • GSK Investigational Site

    Barcelona, 08907, Spain

  • GSK Investigational Site

    Barcelona, 8025, Spain

  • GSK Investigational Site

    Madrid, 28006, Spain

  • GSK Investigational Site

    Madrid, 28007, Spain

  • GSK Investigational Site

    Madrid, 28041, Spain

  • GSK Investigational Site

    Madrid, 28046, Spain

  • GSK Investigational Site

    Madrid, 28222, Spain

  • GSK Investigational Site

    Santiago de Compostela, 15706, Spain

  • GSK Investigational Site

    Valencia, 46020, Spain

  • GSK Investigational Site

    Bebington, CH63 9JP, United Kingdom

  • GSK Investigational Site

    Belfast, BT2 8BG, United Kingdom

  • GSK Investigational Site

    Birmingham, B15 2SQ, United Kingdom

  • GSK Investigational Site

    Bradford on Avon Wiltsh, BA15 1DQ, United Kingdom

  • GSK Investigational Site

    Cardiff, CF15 9SS, United Kingdom

  • GSK Investigational Site

    Corby, NN17 2UR, United Kingdom

  • GSK Investigational Site

    Eynsham, OX29 4QB, United Kingdom

  • GSK Investigational Site

    Glasgow, ML4 3NJ, United Kingdom

  • GSK Investigational Site

    Hexham, NE46 1QJ, United Kingdom

  • GSK Investigational Site

    Lancashire, PR7 7NA, United Kingdom

  • GSK Investigational Site

    Liverpool, L22 0LG, United Kingdom

  • GSK Investigational Site

    Manchester, M15 6SE, United Kingdom

  • GSK Investigational Site

    Orpington, BR5 3QG, United Kingdom

  • GSK Investigational Site

    Oxford, OX4 1XB, United Kingdom

  • GSK Investigational Site

    Peterborough, PE8 6PL, United Kingdom

  • GSK Investigational Site

    Royal Leamington Spa, CV32 4RA, United Kingdom

  • GSK Investigational Site

    Thetford, IP24 1JD, United Kingdom

  • GSK Investigational Site

    Witney, OX28 6JS, United Kingdom

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