1459 Participants Needed

Vaccine for Respiratory Syncytial Virus

Recruiting at 57 trial locations
UG
EG
Overseen ByEU GSK Clinical Trials Call Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

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

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
See 6 more

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
See 17 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of RSVPreF3 OA investigational vaccine

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
Multiple visits (in-person and virtual)

Treatment Details

Interventions

  • RSVPreF3 OA investigational vaccine
Trial Overview The 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).

Find a Clinic Near You

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
**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)
Dame Emma Walmsley profile image

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron profile image

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

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