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NCT07768345From ClinicalTrials.govRecruiting

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