Vaccine for Respiratory Syncytial Virus
Recruiting in Palo Alto (17 mi)
+57 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: GlaxoSmithKline
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
The aim of this study is to demonstrate the immune response and to evaluate safety of the RSVPreF3 OA investigational vaccine in non-immunocompromised adults 18-49 years of age (YOA), who are at increased risk (AIR) for respiratory syncytial virus (RSV) disease, compared to older adults (OA) (\>=) 60 YOA and above
Research Team
Eligibility Criteria
This trial is for non-immunocompromised adults aged 18-49 at increased risk for RSV disease, and older adults aged 60+. Key eligibility details are not provided, so interested individuals should contact the study organizers for full inclusion and exclusion criteria.Inclusion Criteria
Written informed assent obtained from the participant if he/she is less than the legal age prior to performance of any study-specific procedure
Participants living in the general community or in an assisted-living facility that provides minimal assistance
Written or witnessed informed consent obtained from the participant/participant's parent(s)/LAR(s) prior to performance of any study-specific procedure
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Exclusion Criteria
Unstable chronic illness
Use of any investigational or non-registered product other than the study intervention
Concurrent participation in another clinical study involving exposure to an investigational vaccine/product
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Treatment Details
Interventions
- RSVPreF3 OA investigational vaccine (Cancer Vaccine)
Trial OverviewThe study tests the immune response and safety of an investigational vaccine called RSVPreF3 OA. It compares how younger adults (18-49) at higher risk respond to the vaccine versus those who are older (60+).
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Part B: RSV-A-AIR GroupExperimental Treatment1 Intervention
Adult participants, 18-49 YOA, at increased risk (AIR) for RSV disease, receive a single dose of RSVPreF3 OA investigational vaccine at Day 1 and are followed up until end of study (6 months post vaccine dose administration).
Group II: Part A: RSV-OA GroupExperimental Treatment1 Intervention
Older adults (OA) participants, \>=60 YOA, receive a single dose of RSVPreF3 OA investigational vaccine at Day 1 and are followed up until end of study (6 months post vaccine dose administration).
Group III: Part A: RSV-A-AIR GroupExperimental Treatment1 Intervention
Adult participants, 18-49 YOA, at increased risk (AIR) for RSV disease, receive a single dose of RSVPreF3 OA investigational vaccine at Day 1 and are followed up until end of study (6 months post vaccine dose administration).
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Who Is Running the Clinical Trial?
GlaxoSmithKline
Lead Sponsor
Trials
4,834
Recruited
8,389,000+
Headquarters
London, UK
Known For
Vaccines & Medicines
Top Products
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Dame Emma Walmsley
GlaxoSmithKline
Chief Executive Officer since 2017
MA in Classics and Modern Languages from Oxford University
Dr. Hal Barron
GlaxoSmithKline
Chief Medical Officer since 2018
MD from Harvard Medical School