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Not yet recruiting Phase 3 NCT07543380

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

Phase 3 – large-scale trial before approval
Conditions: Respiratory Syncytial Virus (RSV)

Sponsor: Pfizer

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Overview
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.
Description
This is a Phase 3, multicenter, single-arm, open-label study that will assess the safety, tolerability, and immunogenicity of Pfizer's RSVpreF in adults 18 to 59 years of age considered to be at high risk of RSV disease due to certain chronic medical conditions in Japan. Approximately 130 participants 18 to 59 years of age considered at high risk of RSV disease due to certain chronic medical conditions will be enrolled to receive RSVpreF. The total duration of trial participation for each participant will be 2 months. After screening and confirmation of eligibility, a prevaccination blood sample will be collected for immunogenicity assessments and a single dose of study intervention (RSVpreF) will be administered. Participants will report daily reactogenicity data using an electronic device for 7-days or until resolution. Participants will return approximately 1 month later for a follow-up blood draw for immunogenicity assessments and collection of safety information. A telephone follow-up visit will be conducted approximately 2 months after vaccination to collect safety information.
Who can participate
Key Inclusion Criteria: • Underlying health condition(s) that can put the participant at an increased risk of severe RSV/complications including chronic lung , heart, kidney, liver, nervous system, blood, or metabolic diseases Key Exclusion Criteria: * Received any kind of RSV vaccine before participating in this study * Determined as not eligible by the investigator based on the participant's past and present health condition(s), medication(s) and treatment(s) Please refer to the study contact for further eligibility details.
Interventions
RSVpreF
BIOLOGICAL
Locations 5
Japan (5)
Nihonbashi Sakura Clinic
Chuo-ku , Tokyo
Tokyo-Eki Center-building Clinic
Chuo-ku , Tokyo
Fukuwa Clinic
Chuo-ku , Tokyo
Tenjin Sogo Clinic
Fukuoka
Tsuchiura Beryl Clinic
Tsuchiura , Ibaraki
Technical details
Status
Not yet recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
59 Years
Healthy volunteers
No
Start date
11.05.2026
Completion date
31.08.2026
Registry ID
NCT07543380
Source
clinicaltrials.gov
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