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 States10,212 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 range60 Years

SexALL

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…

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

Percentage of participants with RSV-A neutralizing titers >= cut-off in RSV_PreS4 group at Day 31

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 range60 Years

SexALL

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

Percentage of participants with RSV-A neutralizing titers >= cut-off in RSV_PreS4 group at Day 31