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Evaluating an RSV vaccine in older adults

A Phase 3, Randomized, Controlled, Partially Blind, Immuno-bridging Study to Evaluate Immunogenicity, Reactogenicity, Safety and the Occurrence of RSV Associated Respiratory Tract Illness After Administration of a Single Dose of GSK's RSVPreF3 OA Investigational Vaccine in Adults Aged 60 Years and Older

Phase 3 Interventional GlaxoSmithKline · NCT06551181

This study is testing a new RSV vaccine in adults aged 60 and older in China to see how well it works and if it’s safe compared to a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment2600 (estimated)
Ages60 Years and up
SexAll
SponsorGlaxoSmithKline Industry-sponsored
Drugs / interventionsinfliximab, chemotherapy, prednisone
Locations38 sites (Shanghai and 37 other locations)
Trial IDNCT06551181 on ClinicalTrials.gov

What this trial studies

This study aims to assess the immune response and safety of the RSVPreF3 OA investigational vaccine in adults aged 60 years and older in China. Participants will receive either the vaccine or a placebo, and the study will compare immune responses between local participants and those from overseas who participated in a previous study. Additionally, the occurrence of RSV-associated respiratory illnesses will be monitored in participants from China. The study will also evaluate the reactogenicity of the vaccine in all participants.

Who should consider this trial

Good fit: Ideal candidates are adults aged 60 years and older who are medically stable and can comply with study requirements.

Not a fit: Patients with severe acute illnesses or those unable to comply with the study protocol may not benefit from this study.

Why it matters

Potential benefit: If successful, this vaccine could significantly reduce the incidence of respiratory syncytial virus infections in older adults.

How similar studies have performed: Previous studies have shown promising results for similar vaccines targeting RSV, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Adult male or female of ≥60 YOA at the time of study intervention administration, who live in the community dwelling (CD participants).
* 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, perform self-swabbing (study participants in China only), ability to access and utilize a phone or other electronic communications).
* Participants who are medically stable in the opinion of the investigator at the time of vaccination. 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 if considered by the investigator as medically stable.
* Written or witnessed informed consent obtained from the participant (participant must be able to understand the informed consent) prior to performance of any study specific procedure.

Exclusion Criteria:

Medical Conditions:

* History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).
* Any clinical conditions for which serum samples would be prohibited for transfer to local central lab for testing. These clinical conditions include hepatitis B, hepatitis C, HIV and Syphilis based on medical history and physical examination (all participants) and laboratory screening tests (overseas participants).
* Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., current malignancy, human immunodeficiency virus) or immunosuppressive/cytotoxic therapy (e.g., medication used during cancer chemotherapy, organ transplantation, or to treat autoimmune disorders), based on medical history and physical examination (no laboratory testing required).
* Any history of dementia or any medical condition that moderately or severely impairs cognition.
* Recurrent history or uncontrolled neurological disorders or seizures. Participants with medically controlled active or chronic neurological diseases can be enrolled in the study as per investigator assessment, provided that their condition will allow them to comply with the requirements of the protocol (e.g. completion of the diary cards, attend regular phone calls/study site visits, perform self-swabbing (study participants in China only).
* Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study (e.g., life-threatening disease likely to limit survival to less than 1 year).
* Serious or unstable chronic illness.
* Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.

Prior/Concomitant Therapy:

* Previous vaccination with RSV vaccine.
* Use of any investigational or non-registered product (drug, vaccine or invasive medical device) other than the study intervention(s) during the period beginning 30 days before the dose of study intervention(s), or their planned use during the study period.
* Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after study intervention administration, with the exception of COVID-19 and inactivated/subunit influenza vaccines which can be administered up to 14 days before or from 14 days after each study intervention.
* Administration of long-acting immune-modifying drugs or planned administration at any time during the study period (e.g., infliximab).
* Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the study intervention administration or planned administration during the study period.
* Chronic administration (defined as more than 14 consecutive days in total) of immunosuppressants or other immune-modifying drugs during the period starting 90 days prior to the study intervention administration or planned administration during the study period. For corticosteroids, this will mean prednisone \>=20 mg/day, or equivalent. Inhaled and topical steroids are allowed.

Prior/Concurrent Clinical Study Experience:

• 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 intervention (drug/invasive medical device).

Other Exclusion Criteria:

* 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.
* Bedridden participants.
* Planned move during the study conduct that prohibits participation until study end.
* Participation of any study personnel or their immediate dependents, family, or household members.

Where this trial is running

Shanghai and 37 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Respiratory Syncytial Virus InfectionsRespiratory syncytial virusOlder adultsAcute respiratory illnessLower respiratory tract diseaseImmune responseEfficacy studySafety study
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.