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Clinical Trials in the USA / NCT04732871
Active, not recruiting Phase 3

Immunogenicity, Safety, Reactogenicity and Persistence of an Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above

NCT04732871 · tracked via the Priya Life Science USA tracker
Sponsor
GlaxoSmithKline
Phase
Phase 3
Started
2021-02-15
Last updated
2026-07-14

Condition(s) studied

Respiratory Syncytial Virus Infections

Investigational drug(s) / intervention(s)

RSVPreF3 OA investigational vaccine

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)

Trial sites (46)

FacilityCityRegionStatus
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.

More GlaxoSmithKline trials in the USA

Other trials for the same condition

Official registry record

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.

View NCT04732871 on ClinicalTrials.gov ↗ ← All trials in the USA