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NCT Number: NCT07768345

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Rochester Clinical Research

Rochester, New York, 14609, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RSVpreF vaccine

Biological

RSVpreF Vaccine

Primary outcomes

  1. Percentage of participants reporting local reactions

    Time frame: For up to 7 days after vaccination

  2. Percentage of participants reporting systemic events

    Time frame: For up to 7 days after vaccination

  3. Percentage of participants reporting adverse events

    Time frame: Through 1 month after vaccination

  4. Percentage of participants reporting newly diagnosed chronic medical conditions

    Time frame: Through 12 months after vaccination

  5. Percentage of participants reporting serious adverse events

    Time frame: Through 12 months after vaccination

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

    Time frame: Before vaccination, 1 month, 6 months and 12 months after vaccination

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

    Time frame: Before vaccination, 1 month, 6 months and 12 months after vaccination

Secondary outcomes

  1. Seroresponse rate of NTs for RSV A and RSV B

    Time frame: 1 month after revaccination

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 17, 2026
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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