A Study to Learn About Revaccination With a Vaccine Called RSVpreF in Immunocompromised Adults
A PHASE 3, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF REVACCINATION WITH RESPIRATORY SYNCYTIAL VIRUS STABILIZED PREFUSION F SUBUNIT VACCINE (RSVPREF) IN IMMUNOCOMPROMISED ADULTS
- Respiratory Syncytial Virus (RSV)
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Pfizer
- Enrolment target
- 440
- Started
- 31 August 2026
- Main results due
- 2 February 2028
- Study sites
- 10
- Registry updated
- 25 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Key Inclusion Criteria: * Participants ≥18 years of age who are/were immunocompromised at the time of initial RSVpreF vaccination, per study protocol, and will be grouped based on prior RSV vaccination history: * Group 1 will include participants naïve to any RSV vaccine. * Group 2 will include participants who received a single prior dose of RSVpreF (Abrysvo) approximately 1 year (9 to 15 months) prior to enrollment. * Group 3 will include participants who received a single prior dose of RSVpreF (Abrysvo) approximately 2 years (21 to 27 months) prior to enrollment. * Group 4 will include participants who previously received 2 doses of RSVpreF in Study C3671023 Substudy B approximately 3 years (36 to 42 months) prior to enrollment. * Participants should have a life expectancy ≥12 months (365 days) in the opinion of the investigator at enrollment. Key Exclusion Criteria: * Prior history of any subtype of Guillain-Barré Syndrome (GBS) of any etiology. * History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any components of the study intervention(s). * Participants with a history of transplant rejection, or PTLD, or participants who have had treatment for these conditions, within 90 days prior to study enrollment or suspected chronic humoral or cellular rejection. * Receipt of B-cell depleting therapies within 180 days prior to initial study vaccination. Refer to the study contact for further eligibility details.
What this study is about
In the sponsor’s own words, from the registry.
The purpose of this phase 3 study is to learn the safety, tolerability and immunogenicity of revaccination with RSVpreF at approximately 1-, 2-, and 3-year intervals to inform the revaccination interval in immunocompromised adults.
This study is seeking participants who are 18 years of age and older and will be grouped based on prior RSV vaccination history. Participants are required to be immunocompromised per study protocol.
All participants in this study will receive 1 shot to their arm of a RSVPreF vaccine.
Participants will take part in this study for about 12 months and will need to visit the clinical study site at least 4 times.
Study sites(10)
Kaiser Foundation Hospital LAMC
Los Angeles, California, United States
Recruiting
Kaiser Permanente Los Angeles Medical center
Los Angeles, California, United States
Recruiting
Kaiser Permanente
Los Angeles, California, United States
Recruiting
George Washington University
Washington D.C., District of Columbia, United States
Recruiting
The Hope Clinic of Emory University
Decatur, Georgia, United States
Recruiting
NYU Langone Health Vaccine Center
New York, New York, United States
Recruiting
Rochester Clinical Research
Rochester, New York, United States
Recruiting
Duke Vaccine and Trials Unit
Durham, North Carolina, United States
Not yet recruiting
Duke Clinics 2F, 2G
Durham, North Carolina, United States
Not yet recruiting
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Not yet recruiting
Showing 10 of 10 sites. 7 of the 10 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07768345. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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