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Clinical Trials in the USA / NCT07819097
Recruiting Phase 3

A Study to Learn About the Safety and Immune Responses of RSVpreF in Older Adults

NCT07819097 · tracked via the Priya Life Science USA tracker
Sponsor
Pfizer
Phase
Phase 3
Started
2026-09-09
Last updated
2026-10-09

Condition(s) studied

AdultHealthy Participants

Investigational drug(s) / intervention(s)

RSVpreF →Placebo

RSVpreF: Single Dose

Placebo: Single Dose

Study summary

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.

Eligibility

Sex
ALL
Min age
60 Years
Max age
—
Healthy volunteers
Accepted
Key Inclusion Criteria * Participants 60 years of age or older at enrolment. * Healthy participants, or participants with stable long-term medical conditions, if the investigator decides they can take part. * Adults who can walk and live in the community or in assisted-living/long-term care settings with minimal help. * Participants who can give signed informed consent and follow study visits and procedures, including the 7-day electronic diary and blood tests. Key Exclusion Criteria * Confirmed RSV infection 180 days or less before study vaccination. * Any past history of Guillain-Barré syndrome. * Severe reaction to a vaccine or severe allergy to a study vaccine component or related vaccine. * Serious or unstable medical condition that the investigator believes makes the study unsafe. * Immunocompromised status, based on medical history and/or examination. * Previous receipt of any licensed or investigational RSV vaccine or RSV preventive monoclonal antibody, or planned receipt during the study. Please refer to the study contact for further eligibility details Contacts/Locations Central Contact Person: Pfizer CT.gov Call Center Telephone: 1-800-718-1021 Email: ClinicalTrials.gov\_Inquiries@pfizer.com

Primary outcome measure(s)

  • Percentage of participants reporting local reactions: pain at the injection site, redness, and swelling — Within 7 days after vaccination
  • Percentage of participants reporting systemic events: fever, fatigue, headache, vomiting, nausea, diarrhea, muscle pain, and joint pain — Within 7 days after vaccination
  • Percentage of participants reporting adverse events (AEs) — Within 1 month after vaccination
  • Percentage of participants reporting serious adverse events (SAEs) — Through 6 months after vaccination
  • Percentage of participants reporting newly diagnosed chronic medical conditions (NDCMCs) — Through 6 months after vaccination
  • RSV A and RSV B neutralizing antibody levels before vaccination and 1 month after vaccination — Before vaccination and 1 month after vaccination
  • Geometric mean fold rise in RSV A and RSV B neutralizing antibody levels from before vaccination to 1 month after vaccination — Before vaccination to 1 month after vaccination

Trial sites (15)

FacilityCityRegionStatus
Headlands Research - Scottsdale Scottsdale Arizona Not Yet Recruiting
Orange County Research Center Lake Forest California Not Yet Recruiting
Artemis Institute for Clinical Research Riverside California Not Yet Recruiting
Clinical Research Consulting, LLC Milford Connecticut Not Yet Recruiting
George Washington University Washington D.C. District of Columbia Not Yet Recruiting
Solaris Clinical Research Meridian Idaho Not Yet Recruiting
MediSphere Medical Research Center, LLC Evansville Indiana Not Yet Recruiting
IMA Clinical Research Warren Warren Township New Jersey Not Yet Recruiting
Remington-Davis, Inc Columbus Ohio Not Yet Recruiting
DM Clinical Research - Philadelphia Philadelphia Pennsylvania Not Yet Recruiting
J. Lewis Research, Inc. / Foothill Family Clinic Draper Draper Utah Not Yet Recruiting
J. Lewis Research, Inc. / Jordan River Family Medicine South Jordan Utah Not Yet Recruiting
Charlottesville Medical Research Center, LLC Charlottesville Virginia Not Yet Recruiting
Clinical Research Partners, LLC Richmond Virginia Not Yet Recruiting
Huashan Hospital Fudan University Shanghai Shanghai Municipality Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07819097 on ClinicalTrials.gov ↗ ← All trials in the USA