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440 Participants NeededMy employer runs this trial

RSVpreF Vaccine for RSV

Recruiting at 4 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Pfizer
Must not be taking: B-cell depleting therapies
Disqualifiers: Guillain-Barré Syndrome, Transplant rejection, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

PC

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for adults aged 18 and older who have weakened immune systems. Participants must meet specific medical criteria for being immunocompromised, and will be grouped based on whether they've had an RSV vaccine before.

Inclusion Criteria

Group 4 includes 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
I am 18 or older and was immunocompromised when I first got the RSVpreF vaccine.
See 3 more

Exclusion Criteria

History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any components of the study intervention(s)
I have had Guillain-Barré Syndrome in the past.
I have had transplant rejection or PTLD, or treatment for these, in the last 90 days.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 1 shot of RSVpreF vaccine

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety, tolerability, and immunogenicity after vaccination

12 months
At least 4 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • RSVpreF Vaccine

Trial Overview

The study is testing the safety and immune response of getting revaccinated with the RSVpreF vaccine at different yearly intervals (1, 2, or 3 years) in immunocompromised adults. Everyone receives one shot during the study.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Group I: Group 4Experimental Treatment1 Intervention
Group II: Group 3Experimental Treatment1 Intervention
Group III: Group 2Experimental Treatment1 Intervention
Group IV: Group 1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials
4,712
Recruited
50,980,000+
Known For
Vaccine Innovations
Top Products
Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni profile image

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

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