Active — Not RecruitingPhase 3

An Extension and Crossover Vaccination Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 60 Years of Age and Above Who Participated in RSV OA=ADJ-006 Study

United States, Australia, Belgium10,212 participantsStarted 2024-08-01

Plain-language summary

The purpose of this study is: * To investigate the optimal timing for revaccination after the initial RSVPreF3 OA vaccine dose, * To evaluate the long-term immune persistence and safety up to 5 consecutive RSV seasons (approximately 60 months) of a single dose of RSVPreF3 OA vaccine, * To give the opportunity to participants who received only placebo in the RSVOA=ADJ- 006 study, to receive a dose of the RSVPreF3 OA vaccine and collect additional safety information.

Who can participate

Age range

60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or female participants who were previously enrolled in the RSV OA=ADJ-006 study and received placebo (Placebo group) or a single dose of the RSVPreF3 OA vaccine (RSV\_1dose group). * Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, attend regular phone calls/study site visits, ability to access and utilize a phone or other electronic communications). * 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 study entry. Participants with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease, are allowed to participate in this study. 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 study intervention. * Hypersensitivity to latex. * Serious or unstable chronic illness. * Recurrent or un-controlled neurological disorders or seizures. * Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study. * Any other medi…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

RSV-A neutralizing titers expressed as Geometric mean titers (GMTs) in RSV_PreS4 group at Day 1

Timeframe: At Day 1

RSV-A neutralizing titers expressed as GMTs in RSV_PreS4 group at Day 31

Timeframe: At Day 31

RSV-B neutralizing titers expressed as GMTs in RSV_PreS4 group at Day 1

Timeframe: At Day 1

RSV-B neutralizing titers expressed as GMTs in RSV_PreS4 group at Day 31

Timeframe: At Day 31

RSV-A neutralizing titers expressed as Mean geometric increase (MGI) in RSV_PreS4 group

Timeframe: From Day 1 to Day 31

RSV-B neutralizing titers expressed as MGI in RSV_PreS4 group

Timeframe: From Day 1 to Day 31

Percentage of participants with RSV-A neutralizing titers greater than or equal to (>=) cut-off in RSV_PreS4 group at Day 1

Timeframe: At Day 1

Trial details

NCT IDNCT06534892

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-09-30

View on ClinicalTrials.gov More Respiratory Syncytial Virus Infections trials

Plain-language summary

Who can participate

Age range

60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

RSV-A neutralizing titers expressed as Geometric mean titers (GMTs) in RSV_PreS4 group at Day 1

Timeframe: At Day 1

RSV-A neutralizing titers expressed as GMTs in RSV_PreS4 group at Day 31

Timeframe: At Day 31

RSV-B neutralizing titers expressed as GMTs in RSV_PreS4 group at Day 1

Timeframe: At Day 1

RSV-B neutralizing titers expressed as GMTs in RSV_PreS4 group at Day 31

Timeframe: At Day 31

RSV-A neutralizing titers expressed as Mean geometric increase (MGI) in RSV_PreS4 group

Timeframe: From Day 1 to Day 31

RSV-B neutralizing titers expressed as MGI in RSV_PreS4 group

Timeframe: From Day 1 to Day 31

Percentage of participants with RSV-A neutralizing titers greater than or equal to (>=) cut-off in RSV_PreS4 group at Day 1

Timeframe: At Day 1