Phase 3 RSVpreF Vaccine Trial, Japan, High-Risk Adults 18-59
Summary
NIH ClinicalTrials.gov has registered a Phase 3 study (NCT07543380) evaluating the immune response and safety of the RSVpreF vaccine in adults 18-59 years old who have health conditions placing them at increased risk of severe Respiratory Syncytial Virus disease. The study is being conducted in Japan, lasts approximately 2 months, and requires at least 2 site visits with a follow-up phone call 2 months after vaccination.
What changed
NIH ClinicalTrials.gov added a new Phase 3 trial registration (NCT07543380) for the RSVpreF vaccine being evaluated for immune response and safety in Japanese adults with increased risk of severe RSV disease due to underlying health conditions. The approximately 2-month study will enroll participants aged 18-59 and requires at least two site visits plus a 2-month post-vaccination follow-up call.
Healthcare providers and pharmaceutical companies monitoring RSV vaccine development should note this Phase 3 trial registration on ClinicalTrials.gov as an indicator of ongoing vaccine research for high-risk adult populations.
Archived snapshot
Apr 21, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
A Study to Learn Safety and Immune Response to Study Vaccine -RSVpreF in Adults at High Risk of Severe RSV Disease.
Phase 3 NCT07543380 Kind: PHASE3 Apr 21, 2026
Abstract
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.
Conditions: Respiratory Syncytial Virus (RSV)
Interventions: RSVpreF
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