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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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 (6)