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NOT YET RECRUITING
NCT07543380
PHASE3

A Study to Learn Safety and Immune Response to Study Vaccine -RSVpreF in Adults at High Risk of Severe RSV Disease.

Sponsor: Pfizer

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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