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A Study to Learn About Revaccination With a Vaccine Called RSVpreF in Immunocompromised Adults

RecruitingPhase 3

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

Who can join

Ages 18 and older · All sexes

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.

About the study

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.

What is being tested

Sponsor: Pfizer · Participants: 440 · Started: Aug 31, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07768345

Locations in the U.S.

CaliforniaKaiser Foundation Hospital LAMC, Los Angeles
Kaiser Permanente, Los Angeles
Kaiser Permanente Los Angeles Medical center, Los Angeles
District of ColumbiaGeorge Washington University, Washington D.C.
GeorgiaThe Hope Clinic of Emory University, Decatur
New YorkNYU Langone Health Vaccine Center, New York
Rochester Clinical Research, Rochester
North CarolinaDuke Clinics 2F, 2G, Durham (Not yet recruiting)
Duke Vaccine and Trials Unit, Durham (Not yet recruiting)
PennsylvaniaAltoona Center for Clinical Research, Duncansville (Not yet recruiting)

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.