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RecruitingPhase 3

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

Pfizer · NCT07768345

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
440
US sites recruiting
13
Study start
August 31, 2026
Record last updated
October 14, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: RSVpreF Vaccine

Conditions: Respiratory Syncytial Virus (RSV)

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

Study contacts (from the official record)

  • Pfizer CT.gov Call Center · 1-800-718-1021 · ClinicalTrials.gov_Inquiries@pfizer.com
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