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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
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
- RSVpreF Vaccine (biological)
Sponsor: Pfizer · Participants: 440 · Started: Aug 31, 2026
Contact the study team
- Pfizer CT.gov Call Center · Phone: 1-800-718-1021
Official record on ClinicalTrials.gov — NCT07768345
Locations in the U.S.
| California | Kaiser Foundation Hospital LAMC, Los Angeles Kaiser Permanente, Los Angeles Kaiser Permanente Los Angeles Medical center, Los Angeles |
| District of Columbia | George Washington University, Washington D.C. |
| Georgia | The Hope Clinic of Emory University, Decatur |
| New York | NYU Langone Health Vaccine Center, New York Rochester Clinical Research, Rochester |
| North Carolina | Duke Clinics 2F, 2G, Durham (Not yet recruiting) Duke Vaccine and Trials Unit, Durham (Not yet recruiting) |
| Pennsylvania | Altoona 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.