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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Pfizer • ClinicalTrials.gov ID: NCT07768345

Registry updated: 2026-10-14
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Description

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.

Interventions

  • RSVpreF Vaccine (Biological)
    RSVpreF Vaccine

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.

Conditions

Respiratory Syncytial Virus (RSV)

Locations

  • Kaiser Foundation Hospital LAMC — Los Angeles, California, United States
  • Kaiser Permanente Los Angeles Medical center — Los Angeles, California, United States
  • Kaiser Permanente — Los Angeles, California, United States
  • George Washington University — Washington D.C., District of Columbia, United States
  • The Hope Clinic of Emory University — Decatur, Georgia, United States
  • University of Iowa — Iowa City, Iowa, United States
  • University of Iowa, Infectious Disease Research Laboratory, VA Medical Center — Iowa City, Iowa, United States
  • University of Maryland, Institute of Human Virology — Baltimore, Maryland, United States
  • Washington University School of Medicine — St Louis, Missouri, United States
  • NYU Langone Health Vaccine Center — New York, New York, United States
  • Rochester Clinical Research — Rochester, New York, United States
  • University of Rochester Investigational Drug Services — Rochester, New York, United States
  • University of Rochester Medical Center-Infectious Diseases Research Clinic — Rochester, New York, United States
  • Duke Vaccine and Trials Unit — Durham, North Carolina, United States
  • Duke Clinics 2F, 2G — Durham, North Carolina, United States
  • Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
  • Epic Medical Research-Desoto — DeSoto, Texas, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record