A Study to Learn About the Safety and Immune Responses of RSVpreF in Older Adults
Public ClinicalTrials.gov record NCT07819097. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
AN INTERVENTIONAL PHASE 3 STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN PARTICIPANTS 60 YEARS OF AGE AND OLDER
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07819097
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 600 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 60 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 9, 2026 (Actual)
- Primary completion
- May 16, 2027 (Estimated)
- Completion
- May 16, 2027 (Estimated)
- Last update posted
- Oct 9, 2026
2026 – 2027
United States locations
- U.S. sites
- 14
- U.S. states
- 11
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Headlands Research - Scottsdale | Scottsdale | Arizona | 85260 | Not yet recruiting |
| Orange County Research Center | Lake Forest | California | 92630 | Not yet recruiting |
| Artemis Institute for Clinical Research | Riverside | California | 92503 | Not yet recruiting |
| Clinical Research Consulting, LLC | Milford | Connecticut | 06460 | Not yet recruiting |
| George Washington University | Washington D.C. | District of Columbia | 20037 | Not yet recruiting |
| Solaris Clinical Research | Meridian | Idaho | 83646 | Not yet recruiting |
| MediSphere Medical Research Center, LLC | Evansville | Indiana | 47714 | Not yet recruiting |
| IMA Clinical Research Warren | Warren Township | New Jersey | 07059 | Not yet recruiting |
| Remington-Davis, Inc | Columbus | Ohio | 43215 | Not yet recruiting |
| DM Clinical Research - Philadelphia | Philadelphia | Pennsylvania | 19107 | Not yet recruiting |
| J. Lewis Research, Inc. / Foothill Family Clinic Draper | Draper | Utah | 84020 | Not yet recruiting |
| J. Lewis Research, Inc. / Jordan River Family Medicine | South Jordan | Utah | 84095 | Not yet recruiting |
| Charlottesville Medical Research Center, LLC | Charlottesville | Virginia | 22911 | Not yet recruiting |
| Clinical Research Partners, LLC | Richmond | Virginia | 23226 | Not yet recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07819097, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 9, 2026 · Synced Nov 11, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07819097 live on ClinicalTrials.gov.