RSVpreF Vaccine for RSV in Older Adults

Not yet recruiting at 5 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Pfizer
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 study is to learn about the safety, tolerability, and immune response of the RSVpreF vaccine in healthy older adults.

Participants will take part in this study for about 6 months.

The study will include people in China and the United States. In China, participants will receive either RSVpreF or placebo. A placebo is a dummy vaccine with no active ingredient, but it looks just like the vaccine being studied. In the United States, all participants will receive RSVpreF.

Researchers will check for any reactions. They will also check blood test results to learn how the body responds to the vaccine.

The main questions the study aims to answer are:

* What local reactions and systemic events (body-wide symptoms) do participants have after a RSVpreF vaccination?

* What medical problems do participants have after a RSVpreF vaccination?

* Researchers will compare antibody levels from blood tests between the China cohort and the US cohort. An antibody is a substance in the body that try to fight off an infection or foreign substance.

Participants will:

* Have a screening visit to make sure they qualify for the study (participants in China will have this visit before the day of vaccination)

* Receive the RSVpreF vaccination (or a placebo injection if in the China cohort) once at Visit 1.

* Have a telephone or clinic visit 1 week later to assess local reactions and systemic events.

* Have a clinic visit a month after vaccination for a checkup and tests.

* Have a telephone or clinic visit 6 months after vaccination for a health check.

* Have a blood test at screening (if in the China cohort only), on the day of vaccination and 1 month after vaccination.

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 healthy older adults in China and the United States. Participants should not have major health problems and must be able to attend study visits over about 6 months.

Inclusion Criteria

I am 60 years old or older.
Participants who can give signed informed consent and follow study visits and procedures, including the 7-day electronic diary and blood tests
I am an adult who can walk and live with little or no assistance.
See 1 more

Exclusion Criteria

Immunocompromised status based on medical history and/or examination
I have not received any RSV vaccine or preventive antibody, and do not plan to during the study.
Any past history of Guillain-Barré syndrome
See 3 more

What Are the Treatments Tested in This Trial?

Interventions

  • RSVpreF

Trial Overview

The study is testing the safety and immune response of a new RSV vaccine called RSVpreF. In China, participants get either the vaccine or a placebo; in the US, all get the vaccine. Researchers will monitor reactions and antibody levels.

How Is the Trial Designed?

3

Treatment groups

Active Control

Placebo Group

Group I: China RSVpreFActive Control1 Intervention
Group II: US RSVpreFActive Control1 Intervention
Group III: China PlaceboPlacebo Group1 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