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

Part of paid clinical trials in Milford, Connecticut.

Sponsor
Pfizer
Study ID
NCT07819097
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Adult
  • Healthy Participants

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • RSVpreF — BIOLOGICAL
    Single Dose
  • Placebo — OTHER
    Single Dose

Study Details

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.

Key Dates

First listed
Sep 14, 2026
Start date
Sep 9, 2026
Status verified
Sep 2026
Primary completion
May 15, 2027
Completion
May 15, 2027

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Placebo Comparator: China Placebo
    Single dose, Placebo vaccine
  • Active Comparator: China RSVpreF
    Single dose, RSVpreF vaccine
  • Active Comparator: US RSVpreF
    Single dose, RSVpreF vaccine

Primary Outcome Measure

Percentage of participants reporting local reactions: pain at the injection site, redness, and swelling [ Time Frame: Within 7 days after vaccination ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Clinical Research Consulting, LLCMilfordConnecticut06460-
Remington-Davis, IncColumbusOhio43215-
DM Clinical Research - PhiladelphiaPhiladelphiaPennsylvania19107-
J. Lewis Research, Inc. / Foothill Family Clinic DraperDraperUtah84020-
Clinical Research Partners, LLCRichmondVirginia23226-

Find similar trials in Milford, CT

By research site
Clinical Research Consulting, LLC· Milford, CTRemington-Davis, Inc· Columbus, OHDM Clinical Research - Philadelphia· Philadelphia, PAJ. Lewis Research, Inc. / Foothill Family Clinic Draper· Draper, UTClinical Research Partners, LLC· Richmond, VA

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