RSV Vaccine for Older Adults

Recruiting in Palo Alto (17 mi)

+41 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?

This trial is testing a new RSV vaccine by GSK in adults aged 60 and above. The vaccine aims to boost the immune system's ability to fight RSV. The study will also look at how safe the vaccine is and how long its effects last.

Research Team

Eligibility Criteria

Adults aged 60 or older, both from the community and long-term care facilities, can join this trial if they're medically stable. This includes those with controlled chronic conditions like diabetes or heart disease. People with severe allergies to vaccine ingredients, latex hypersensitivity, significant illnesses preventing study completion, recent use of immune-modifying drugs, a history of RSV vaccination or substance abuse cannot participate.

Inclusion Criteria

Written or witnessed informed consent obtained from the participant prior to performance of any study specific procedure

Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol

I am 60 years or older and live at home or in a long-term care facility.

See 1 more

Exclusion Criteria

You have a severe or unstable long-term illness.

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

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

See 16 more

Treatment Details

Interventions

RSVPreF3 OA investigational vaccine (Virus Therapy)

Trial OverviewThe trial is testing an investigational RSV vaccine called RSVPreF3 OA in seniors. It aims to evaluate the safety and immune response up to three years after a single dose. The study will also look at how people respond to additional doses given on different schedules.

Participant Groups

3Treatment groups

Experimental Treatment

Group I: RSV_flexible revaccination GroupExperimental Treatment1 Intervention

Participants receive one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 24 months post-Dose 1 and at 48 months post-Dose 1, respectively and are followed up until the study end (Month 60).

Group II: RSV_annual GroupExperimental Treatment1 Intervention

Participants receive one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and are followed up until the study end (Month 60).

Group III: RSV_1dose GroupExperimental Treatment1 Intervention

Participants receive one dose of RSVPreF3 OA investigational vaccine at Day 1 and are followed up until Month 36. At Month 36, participants in this group will be re-randomized in 2 groups (RSV_1dose_M36 and RSV_1dose_flexible groups), which will be followed up until the study end (Month 60).