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A Study to Learn Safety and Immune Response to Study Vaccine -RSVpreF in Adults at High Risk of Severe RSV Disease.
Sponsor: Pfizer
Summary
The purpose of the study is to learn about the immune response after a RSVpreF vaccination. This study is being conducted in Japan. RSV is a common virus that can cause infections of the lungs and airways. The study is seeking participants who are: * 18 to 59 years of age * adults with health condition(s) that can put them at an increased risk of severe RSV disease It will also learn about the safety of RSVpreF vaccination. The study lasts about 2 months. Adults need to visit the research site at least 2 times. The participant will receive a phone call 2 months after vaccination for health checks.
Official title: A PHASE 3, MULTICENTER, SINGLE-ARM, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS (RSV) PREFUSION F SUBUNIT VACCINE IN ADULTS CONSIDERED AT HIGH RISK OF SEVERE RSV DISEASE IN JAPAN
Key Details
Gender
All
Age Range
18 Years - 59 Years
Study Type
INTERVENTIONAL
Enrollment
130
Start Date
2026-05-11
Completion Date
2026-08-31
Last Updated
2026-05-14
Healthy Volunteers
No
Conditions
Interventions
RSVpreF
RSV Vaccine
Locations (5)
Tsuchiura Beryl Clinic
Tsuchiura, Ibaraki, Japan
Nihonbashi Sakura Clinic
Chuo-ku, Tokyo, Japan
Tokyo-Eki Center-building Clinic
Chuo-ku, Tokyo, Japan
Fukuwa Clinic
Chuo-ku, Tokyo, Japan
Tenjin Sogo Clinic
Fukuoka, Japan