Immunogenicity, Safety, Reactogenicity and Persistence of an Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above
RSVPreF3 OA investigational vaccine: RSVPreF3 OA investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm.
Study summary
The purpose of this study is to assess the safety, reactogenicity, immunogenicity and long-term persistence of immune response up to 5 years following a single dose vaccination of GSK's investigational vaccine RSVPreF3 OA, in adults aged 60 years and above. The study will also evaluate the immunogenicity, safety and reactogenicity of additional vaccine doses given according to different revaccination schedules.
Eligibility
Sex
ALL
Min age
60 Years
Max age
—
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Humoral Immune Response in Terms of Respiratory Syncytial Virus (RSV)-A Neutralizing Antibody Geometric Mean Titers (GMTs) at Day 1 — At Day 1 RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).
Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Day 31 — At Day 31 RSV-A neutralizing antibodies were given as GMTs and expressed as ED60.
Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 6 — At Month 6 RSV-A neutralizing antibodies were given as GMTs and expressed as ED60.
Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 12 — At Month 12 RSV-A neutralizing antibodies were given as GMTs and expressed as ED60.
Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Day 1 — At Day 1 RSV-B neutralizing antibodies measured as GMTs and expressed as ED60.
Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Day 31 — At Day 31 RSV-B neutralizing antibodies measured as GMTs and expressed as ED60.
Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 6 — At Month 6 RSV-B neutralizing antibodies measured as GMTs and expressed as ED60.
Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 12 — At Month 12 RSV-B neutralizing antibodies measured as GMTs and expressed as ED60.
Trial sites (46)
Facility
City
Region
Status
GSK Investigational Site
Mobile
Alabama
GSK Investigational Site
Phoenix
Arizona
GSK Investigational Site
Riverside
California
GSK Investigational Site
San Diego
California
GSK Investigational Site
Coral Gables
Florida
GSK Investigational Site
Fort Myers
Florida
GSK Investigational Site
Sarasota
Florida
GSK Investigational Site
The Villages
Florida
GSK Investigational Site
Evansville
Indiana
GSK Investigational Site
Wichita
Kansas
GSK Investigational Site
Richfield
Minnesota
GSK Investigational Site
Kansas City
Missouri
GSK Investigational Site
Rochester
New York
GSK Investigational Site
Mt. Pleasant
South Carolina
GSK Investigational Site
Spartanburg
South Carolina
GSK Investigational Site
San Antonio
Texas
GSK Investigational Site
Norfolk
Virginia
GSK Investigational Site
Wenatchee
Washington
GSK Investigational Site
Espoo
Finland
GSK Investigational Site
Helsinki
Finland
GSK Investigational Site
Helsinki
Finland
GSK Investigational Site
Jarvenpaa
Finland
GSK Investigational Site
Kokkola
Finland
GSK Investigational Site
Oulu
Finland
GSK Investigational Site
Pori
Finland
GSK Investigational Site
Seinäjoki
Finland
GSK Investigational Site
Tampere
Finland
GSK Investigational Site
Turku
Finland
GSK Investigational Site
Essen
Germany
GSK Investigational Site
Essen
Germany
GSK Investigational Site
Goch
Germany
GSK Investigational Site
Hamburg
Germany
GSK Investigational Site
Mainz
Germany
GSK Investigational Site
München
Germany
GSK Investigational Site
Wallerfing
Germany
GSK Investigational Site
Würzburg
Germany
GSK Investigational Site
Fukuoka
Japan
GSK Investigational Site
Kumamoto
Japan
GSK Investigational Site
Tokyo
Japan
GSK Investigational Site
Changhua
Taiwan
+ 6 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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