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

NCT07768345 | Recruiting Phase 3 FDA Drug

• 1 other identifier: C3671085
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Respiratory Syncytial Virus (RSV)

Outcome Measures

Primary Outcomes (7)

• Percentage of participants reporting local reactions

  For up to 7 days after vaccination

• Percentage of participants reporting systemic events

  For up to 7 days after vaccination

• Percentage of participants reporting adverse events

  Through 1 month after vaccination

• Percentage of participants reporting newly diagnosed chronic medical conditions

  Through 12 months after vaccination

• Percentage of participants reporting serious adverse events

  Through 12 months after vaccination

• Neutralizing Titers (NTs) for RSV A and RSV B expressed as Geometric Mean Titer (GMT)

  Before vaccination, 1 month, 6 months and 12 months after vaccination

• NTs for RSV A and RSV B expressed as Geometric Mean Fold Rise (GMFR)

  Before vaccination, 1 month, 6 months and 12 months after vaccination

Secondary Outcomes (1)

• Seroresponse rate of NTs for RSV A and RSV B

  1 month after revaccination

Study Arms (4)

Group 1

EXPERIMENTAL

RSVpreF Vaccine

Biological: RSVpreF Vaccine

Group 2

EXPERIMENTAL

RSVpreF Vaccine

Biological: RSVpreF Vaccine

Group 3

EXPERIMENTAL

RSVpreF Vaccine

Biological: RSVpreF Vaccine

Group 4

EXPERIMENTAL

RSVpreF Vaccine

Biological: RSVpreF Vaccine

Interventions

RSVpreF Vaccine BIOLOGICAL

RSVpreF Vaccine

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (10)

Kaiser Foundation Hospital LAMC

Los Angeles, California, 90027, United States

RECRUITING

Kaiser Permanente Los Angeles Medical center

Los Angeles, California, 90027, United States

RECRUITING

Kaiser Permanente

Los Angeles, California, 90027, United States

RECRUITING

George Washington University

Washington D.C., District of Columbia, 20037, United States

RECRUITING

The Hope Clinic of Emory University

Decatur, Georgia, 30030, United States

RECRUITING

NYU Langone Health Vaccine Center

New York, New York, 10016, United States

RECRUITING

Rochester Clinical Research

Rochester, New York, 14609, United States

RECRUITING

Duke Vaccine and Trials Unit

Durham, North Carolina, 27703, United States

NOT YET RECRUITING

Duke Clinics 2F, 2G

Durham, North Carolina, 27710, United States

NOT YET RECRUITING

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

NOT YET RECRUITING

Related Links

• To obtain contact information for a study center near you, click here.

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Central Study Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021; ClinicalTrials.gov_Inquiries@pfizer.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 17, 2026
• Study Start: August 31, 2026
• Primary Completion (Estimated): February 2, 2028
• Study Completion (Estimated): February 2, 2028
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

US (10)