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An Extension and Crossover Vaccination Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 60 Years of Age and Above Who Participated in RSV OA=ADJ-006 Study

NCT ID: NCT06534892

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

10356 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2026-09-30

Brief Summary

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The purpose of this study is:

* To investigate the optimal timing for revaccination after the initial RSVPreF3 OA vaccine dose,
* To evaluate the long-term immune persistence and safety up to 5 consecutive RSV seasons (approximately 60 months) of a single dose of RSVPreF3 OA vaccine,
* To give the opportunity to participants who received only placebo in the RSVOA=ADJ- 006 study, to receive a dose of the RSVPreF3 OA vaccine and collect additional safety information.

Detailed Description

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Conditions

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Respiratory Syncytial Virus Infections

Keywords

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Respiratory syncytial virus (RSV) Older adults RSVPreF3 OA vaccine Immunogenicity Safety RSV Season

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is an extension and crossover study.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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RSV_PreS4

Participants in this group will receive 1 dose of RSVPreF3 OA vaccine before RSV Season 4.

Group Type EXPERIMENTAL

RSVPreF3 OA vaccine

Intervention Type BIOLOGICAL

RSVPreF3 OA vaccine administered at different timepoints (revaccination groups) or for the first time (crossover group)

RSV_PreS5

Participants in this group will receive 1 dose of RSVPreF3 OA vaccine before RSV Season 5.

Group Type EXPERIMENTAL

RSVPreF3 OA vaccine

Intervention Type BIOLOGICAL

RSVPreF3 OA vaccine administered at different timepoints (revaccination groups) or for the first time (crossover group)

RSV_1Dose

Participants in this group will not receive any additional dose of RSV PreF3 OA vaccine.

Group Type NO_INTERVENTION

No interventions assigned to this group

Crossover

Participants in this group will receive a single dose of RSVPreF3 OA vaccine.

Group Type EXPERIMENTAL

RSVPreF3 OA vaccine

Intervention Type BIOLOGICAL

RSVPreF3 OA vaccine administered at different timepoints (revaccination groups) or for the first time (crossover group)

Interventions

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RSVPreF3 OA vaccine

RSVPreF3 OA vaccine administered at different timepoints (revaccination groups) or for the first time (crossover group)

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.


* 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.


• 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.


* 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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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GSK Investigational Site

Birmingham, Alabama, United States

Site Status RECRUITING

GSK Investigational Site

Birmingham, Alabama, United States

Site Status RECRUITING

GSK Investigational Site

Huntsville, Alabama, United States

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GSK Investigational Site

Phoenix, Arizona, United States

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GSK Investigational Site

Tucson, Arizona, United States

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GSK Investigational Site

Cerritos, California, United States

Site Status COMPLETED

GSK Investigational Site

Doral, Florida, United States

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GSK Investigational Site

Fort Myers, Florida, United States

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GSK Investigational Site

Jacksonville, Florida, United States

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GSK Investigational Site

Lake City, Florida, United States

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GSK Investigational Site

Melbourne, Florida, United States

Site Status RECRUITING

GSK Investigational Site

Miami, Florida, United States

Site Status RECRUITING

GSK Investigational Site

Orlando, Florida, United States

Site Status COMPLETED

GSK Investigational Site

Pinellas Park, Florida, United States

Site Status COMPLETED

GSK Investigational Site

The Villages, Florida, United States

Site Status RECRUITING

GSK Investigational Site

West Palm Beach, Florida, United States

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GSK Investigational Site

Atlanta, Georgia, United States

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GSK Investigational Site

Savannah, Georgia, United States

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GSK Investigational Site

Chicago, Illinois, United States

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GSK Investigational Site

Evansville, Indiana, United States

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GSK Investigational Site

Mishawaka, Indiana, United States

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GSK Investigational Site

El Dorado, Kansas, United States

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GSK Investigational Site

Newton, Kansas, United States

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GSK Investigational Site

Wichita, Kansas, United States

Site Status COMPLETED

GSK Investigational Site

Wichita, Kansas, United States

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GSK Investigational Site

Lexington, Kentucky, United States

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GSK Investigational Site

Rockville, Maryland, United States

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GSK Investigational Site

Richfield, Minnesota, United States

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GSK Investigational Site

Kansas City, Missouri, United States

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GSK Investigational Site

St Louis, Missouri, United States

Site Status COMPLETED

GSK Investigational Site

Omaha, Nebraska, United States

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GSK Investigational Site

Las Vegas, Nevada, United States

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GSK Investigational Site

New York, New York, United States

Site Status COMPLETED

GSK Investigational Site

Rochester, New York, United States

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GSK Investigational Site

Hickory, North Carolina, United States

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GSK Investigational Site

Mooresville, North Carolina, United States

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GSK Investigational Site

Rocky Mount, North Carolina, United States

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GSK Investigational Site

Salisbury, North Carolina, United States

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GSK Investigational Site

Winston-Salem, North Carolina, United States

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GSK Investigational Site

Centerville, Ohio, United States

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GSK Investigational Site

Cincinnati, Ohio, United States

Site Status COMPLETED

GSK Investigational Site

Columbus, Ohio, United States

Site Status COMPLETED

GSK Investigational Site

Erie, Pennsylvania, United States

Site Status RECRUITING

GSK Investigational Site

Pittsburgh, Pennsylvania, United States

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GSK Investigational Site

Anderson, South Carolina, United States

Site Status COMPLETED

GSK Investigational Site

Mt. Pleasant, South Carolina, United States

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GSK Investigational Site

Knoxville, Tennessee, United States

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GSK Investigational Site

Memphis, Tennessee, United States

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GSK Investigational Site

Dallas, Texas, United States

Site Status COMPLETED

GSK Investigational Site

Fort Worth, Texas, United States

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GSK Investigational Site

Houston, Texas, United States

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GSK Investigational Site

Keller, Texas, United States

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GSK Investigational Site

San Antonio, Texas, United States

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GSK Investigational Site

San Antonio, Texas, United States

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GSK Investigational Site

Salt Lake City, Utah, United States

Site Status COMPLETED

GSK Investigational Site

Norfolk, Virginia, United States

Site Status RECRUITING

GSK Investigational Site

Botany, New South Wales, Australia

Site Status COMPLETED

GSK Investigational Site

Coffs Harbour, New South Wales, Australia

Site Status COMPLETED

GSK Investigational Site

Darlinghurst, New South Wales, Australia

Site Status COMPLETED

GSK Investigational Site

Taringa, Queensland, Australia

Site Status COMPLETED

GSK Investigational Site

Tarragindi, Queensland, Australia

Site Status COMPLETED

GSK Investigational Site

Camberwell, Victoria, Australia

Site Status COMPLETED

GSK Investigational Site

Geelong, Victoria, Australia

Site Status RECRUITING

GSK Investigational Site

Spearwood, Western Australia, Australia

Site Status COMPLETED

GSK Investigational Site

Diepenbeek, , Belgium

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GSK Investigational Site

Edegem, , Belgium

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GSK Investigational Site

Erpent, , Belgium

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GSK Investigational Site

Genk, , Belgium

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GSK Investigational Site

Ghent, , Belgium

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GSK Investigational Site

Ieper, , Belgium

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GSK Investigational Site

Kluisbergen, , Belgium

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GSK Investigational Site

Linkebeek, , Belgium

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GSK Investigational Site

Linkebeek, , Belgium

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GSK Investigational Site

Mechelen, , Belgium

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GSK Investigational Site

Tremelo, , Belgium

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GSK Investigational Site

Edmonton, Alberta, Canada

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GSK Investigational Site

New Westminster, British Columbia, Canada

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GSK Investigational Site

Surrey, British Columbia, Canada

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GSK Investigational Site

Vancouver, British Columbia, Canada

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GSK Investigational Site

Victoria, British Columbia, Canada

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GSK Investigational Site

Victoria, British Columbia, Canada

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GSK Investigational Site

Halifax, Nova Scotia, Canada

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GSK Investigational Site

Truro, Nova Scotia, Canada

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GSK Investigational Site

Greater Sudbury, Ontario, Canada

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GSK Investigational Site

London-Ontario, Ontario, Canada

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GSK Investigational Site

Ottawa, Ontario, Canada

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GSK Investigational Site

Sarnia, Ontario, Canada

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GSK Investigational Site

Toronto, Ontario, Canada

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GSK Investigational Site

Chicoutimi, Quebec, Canada

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GSK Investigational Site

Mirabel, Quebec, Canada

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GSK Investigational Site

Pointe-Claire, Quebec, Canada

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GSK Investigational Site

Québec, Quebec, Canada

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GSK Investigational Site

Saint-Charles-Borromée, Quebec, Canada

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GSK Investigational Site

Sainte-Foy, Quebec, Canada

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GSK Investigational Site

Sherbrooke, Quebec, Canada

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GSK Investigational Site

Paide, , Estonia

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GSK Investigational Site

Tallinn, , Estonia

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Tallinn, , Estonia

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GSK Investigational Site

Tallinn, , Estonia

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GSK Investigational Site

Tallinn, , Estonia

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GSK Investigational Site

Tartu, , Estonia

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GSK Investigational Site

Espoo, , Finland

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GSK Investigational Site

Helsinki, , Finland

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GSK Investigational Site

Helsinki, , Finland

Site Status COMPLETED

GSK Investigational Site

Järvenpää, , Finland

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GSK Investigational Site

Kokkola, , Finland

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GSK Investigational Site

Oulu, , Finland

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GSK Investigational Site

Seinäjoki, , Finland

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GSK Investigational Site

Tampere, , Finland

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GSK Investigational Site

Turku, , Finland

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GSK Investigational Site

Weinheim, Baden-Wurttemberg, Germany

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GSK Investigational Site

Munich, Bavaria, Germany

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GSK Investigational Site

Freiberg, Saxony, Germany

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GSK Investigational Site

Berlin, , Germany

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GSK Investigational Site

Berlin, , Germany

Site Status COMPLETED

GSK Investigational Site

Berlin, , Germany

Site Status RECRUITING

GSK Investigational Site

Cologne, , Germany

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GSK Investigational Site

Dachau, , Germany

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GSK Investigational Site

Dippoldiswalde, , Germany

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GSK Investigational Site

Dresden, , Germany

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GSK Investigational Site

Essen, , Germany

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GSK Investigational Site

Essen, , Germany

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GSK Investigational Site

Frankfurt, , Germany

Site Status COMPLETED

GSK Investigational Site

Freital, , Germany

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GSK Investigational Site

Goch, , Germany

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GSK Investigational Site

Hamburg, , Germany

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GSK Investigational Site

Hamburg, , Germany

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GSK Investigational Site

Hanover, , Germany

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GSK Investigational Site

Hochheim am Main, , Germany

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GSK Investigational Site

Leipzig, , Germany

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GSK Investigational Site

Mainz, , Germany

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GSK Investigational Site

Schenefeld, , Germany

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GSK Investigational Site

Wallerfing, , Germany

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GSK Investigational Site

Wangen, , Germany

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GSK Investigational Site

Witten, , Germany

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GSK Investigational Site

Würzburg, , Germany

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GSK Investigational Site

Alessandria, , Italy

Site Status COMPLETED

GSK Investigational Site

Bari, , Italy

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GSK Investigational Site

Belluno, , Italy

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GSK Investigational Site

Ferrara, , Italy

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GSK Investigational Site

Napoli, , Italy

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GSK Investigational Site

Negrar Verona, , Italy

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GSK Investigational Site

Palermo, , Italy

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GSK Investigational Site

Pessione - Chieri to, , Italy

Site Status COMPLETED

GSK Investigational Site

Pisa, , Italy

Site Status RECRUITING

GSK Investigational Site

Roma, , Italy

Site Status RECRUITING

GSK Investigational Site

Roma, , Italy

Site Status WITHDRAWN

GSK Investigational Site

Siena, , Italy

Site Status COMPLETED

GSK Investigational Site

Hiroshima, , Japan

Site Status RECRUITING

GSK Investigational Site

Ibaraki, , Japan

Site Status RECRUITING

GSK Investigational Site

Kumamoto, , Japan

Site Status RECRUITING

GSK Investigational Site

Okinawa, , Japan

Site Status RECRUITING

GSK Investigational Site

Saitama, , Japan

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GSK Investigational Site

Shizuoka, , Japan

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GSK Investigational Site

Tokyo, , Japan

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GSK Investigational Site

Tokyo, , Japan

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GSK Investigational Site

Tokyo, , Japan

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GSK Investigational Site

Tokyo, , Japan

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GSK Investigational Site

Yamagata, , Japan

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GSK Investigational Site

Yamaguchi, , Japan

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GSK Investigational Site

Chihuahua City, , Mexico

Site Status COMPLETED

GSK Investigational Site

León, , Mexico

Site Status RECRUITING

GSK Investigational Site

Mexico City, , Mexico

Site Status RECRUITING

GSK Investigational Site

Mérida, , Mexico

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GSK Investigational Site

Monterrey, , Mexico

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GSK Investigational Site

Oaxaca City, , Mexico

Site Status COMPLETED

GSK Investigational Site

Querétaro, , Mexico

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GSK Investigational Site

RM Pharmamexico CITY, , Mexico

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GSK Investigational Site

San Luis Potosí City, , Mexico

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GSK Investigational Site

Grafton Auckland, , New Zealand

Site Status COMPLETED

GSK Investigational Site

Hawke's Bay, , New Zealand

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GSK Investigational Site

Kapiti, , New Zealand

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GSK Investigational Site

Palmerston North, , New Zealand

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GSK Investigational Site

Tauranga, , New Zealand

Site Status COMPLETED

GSK Investigational Site

Wellington, , New Zealand

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GSK Investigational Site

Częstochowa, , Poland

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GSK Investigational Site

Elblag, , Poland

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GSK Investigational Site

Gdansk, , Poland

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GSK Investigational Site

Gdynia, , Poland

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GSK Investigational Site

Katowice, , Poland

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GSK Investigational Site

Katowice, , Poland

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GSK Investigational Site

Katowice, , Poland

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GSK Investigational Site

Krakow, , Poland

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GSK Investigational Site

Lodz, , Poland

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GSK Investigational Site

Lodz, , Poland

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GSK Investigational Site

Poznan, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Wroclaw, , Poland

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Wroclaw, , Poland

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GSK Investigational Site

Gatchina, Leningradskaya Oblast', Russia

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Barnaul, , Russia

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Kemerovo, , Russia

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GSK Investigational Site

Moscow, , Russia

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GSK Investigational Site

Saint Petersburg, , Russia

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GSK Investigational Site

Saint Petersburg, , Russia

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StPetersburg, , Russia

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GSK Investigational Site

StPetersburg, , Russia

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GSK Investigational Site

Yekaterinburg, , Russia

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GSK Investigational Site

Bloemfontein, , South Africa

Site Status COMPLETED

GSK Investigational Site

Cape Town, , South Africa

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GSK Investigational Site

Johannesburg, , South Africa

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GSK Investigational Site

Johannesburg, , South Africa

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GSK Investigational Site

Middelburg, , South Africa

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GSK Investigational Site

Moloto South, , South Africa

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GSK Investigational Site

Reiger Park, , South Africa

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GSK Investigational Site

Tembisa, , South Africa

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GSK Investigational Site

Ansan, , South Korea

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GSK Investigational Site

Bucheon-si Kyunggi-do 14584, , South Korea

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GSK Investigational Site

Daegu, , South Korea

Site Status COMPLETED

GSK Investigational Site

Incheon, , South Korea

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GSK Investigational Site

Jeonju, , South Korea

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Kangwon-do, , South Korea

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GSK Investigational Site

Seoul, , South Korea

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GSK Investigational Site

Seoul, , South Korea

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GSK Investigational Site

Seoul, , South Korea

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GSK Investigational Site

Seoul, , South Korea

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GSK Investigational Site

Seoul, , South Korea

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GSK Investigational Site

Suwon Gyeonggi-do, , South Korea

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GSK Investigational Site

Alcorcón, , Spain

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GSK Investigational Site

Barcelona, , Spain

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GSK Investigational Site

Barcelona, , Spain

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GSK Investigational Site

Barcelona, , Spain

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GSK Investigational Site

Barcelona, , Spain

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GSK Investigational Site

Barcelona, , Spain

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GSK Investigational Site

Barcelona, , Spain

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GSK Investigational Site

Barcelona, , Spain

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GSK Investigational Site

Madrid, , Spain

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GSK Investigational Site

Madrid, , Spain

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GSK Investigational Site

Madrid, , Spain

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GSK Investigational Site

Madrid, , Spain

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GSK Investigational Site

Madrid, , Spain

Site Status COMPLETED

GSK Investigational Site

Santiago de Compostela, , Spain

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GSK Investigational Site

Valencia, , Spain

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GSK Investigational Site

Bebington, , United Kingdom

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GSK Investigational Site

Belfast, , United Kingdom

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GSK Investigational Site

Birmingham, , United Kingdom

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GSK Investigational Site

Bradford on Avon Wiltsh, , United Kingdom

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GSK Investigational Site

Cardiff, , United Kingdom

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GSK Investigational Site

Corby, , United Kingdom

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GSK Investigational Site

Eynsham, , United Kingdom

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GSK Investigational Site

Glasgow, , United Kingdom

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GSK Investigational Site

Hexham, , United Kingdom

Site Status COMPLETED

GSK Investigational Site

Lancashire, , United Kingdom

Site Status COMPLETED

GSK Investigational Site

Liverpool, , United Kingdom

Site Status RECRUITING

GSK Investigational Site

Manchester, , United Kingdom

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GSK Investigational Site

Orpington, , United Kingdom

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GSK Investigational Site

Oxford, , United Kingdom

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GSK Investigational Site

Peterborough, , United Kingdom

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GSK Investigational Site

Royal Leamington Spa, , United Kingdom

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GSK Investigational Site

Thetford, , United Kingdom

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GSK Investigational Site

Witney, , United Kingdom

Site Status RECRUITING

Countries

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United States Australia Belgium Canada Estonia Finland Germany Italy Japan Mexico New Zealand Poland Russia South Africa South Korea Spain United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

US GSK Clinical Trials Call Center

Role: CONTACT

Phone: 877-379-3718

Email: [email protected]

EU GSK Clinical Trials Call Center

Role: CONTACT

Phone: +44 (0) 20 89904466

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

US GSK Clinical Trials Call Center

Role: primary

EU GSK Clinical Trials Call Centre

Role: backup

US GSK Clinical Trials Call Center

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EU GSK Clinical Trials Call Centre

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Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2023-509762-38-00

Identifier Type: OTHER

Identifier Source: secondary_id

222090

Identifier Type: -

Identifier Source: org_study_id