A Study to Learn Safety and Immune Response to Study Vaccine -RSVpreF in Adults at High Risk of Severe RSV Disease.
NCT07543380 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 130
Last updated 2026-05-14
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.
Conditions
- Respiratory Syncytial Virus (RSV)
Interventions
- BIOLOGICAL
-
RSVpreF
RSV Vaccine
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Pfizer CT.gov Call Center · Pfizer
Study Design
- Allocation
- NA
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 59 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-11
- Primary Completion
- 2026-08-31
- Completion
- 2026-08-31
- FDA Drug
- Yes
Countries
- Japan
Study Locations
More Related Trials
-
A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus (RSV) Given to Adults 18 to 49 Years of Age at Increased Risk for Respiratory Syncytial Virus Disease, Compared to Older Adults 60 Years of Age and Above
NCT06389487 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Safety, Tolerability and Immunogenicity of an Investigational RSV Vaccine Candidate (Ad26.RSV.preF) in Adults 18 to 50 Years of Age, and RSV-seropositive Toddlers 12 to 24 Months of Age
NCT03303625 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Immunogenicity, Safety, Reactogenicity and Persistence of an Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above
NCT04732871 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus Given to Chinese Adults 18 to 59 Years of Age at Increased Risk of Respiratory Syncytial Virus Disease
NCT07220109 ·Status: RECRUITING ·Phase: PHASE3
-
Study to Evaluate the Efficacy, Immunogenicity, and Safety of RSVpreF in Adults.
NCT05035212 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 50-59 Years of Age, Including Adults at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease, Compared to Older Adults 60 Years of Age and Above
NCT05590403 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate the Safety and Immunogenicity of Investigational Vaccines Using the RSV (Respiratory Syncytial Virus) Monovalent Antigen in Healthy Participants 18 to 49 Years of Age
NCT07071558 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Various Respiratory Syncytial Virus (RSV) Pre-Fusion (preF)-Based Vaccine Formulations in Adults Aged 60 Years and Older
NCT05327816 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
A Study of an Adenovirus Serotype 26 Pre-fusion Conformation-stabilized F Protein (Ad26. RSV. preF) Based Respiratory Syncytial Virus (RSV) Vaccine in the Prevention of Lower Respiratory Tract Disease in Adults Aged 60 Years and Older
NCT04908683 ·Status: COMPLETED ·Phase: PHASE3
-
Study of RSVpreF Vaccination and RSV Challenge in Healthy Adults
NCT04785612 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Test GlaxoSmithKline's (GSK) Respiratory Syncytial Virus RSV Candidate Vaccine's Safety and Immune Response in Japanese Older Adults
NCT04090658 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Assess Safety, Tolerability and Immunogenicity of RSVpreF From Multidose Vials in Healthy Female Adults.
NCT06473519 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Safety and Immunogenicity for Regimen Selection of Ad26.RSV.preF and/or RSV preF Protein Combinations Followed by Expanded Safety Evaluation in Adults Aged 60 Years and Older
NCT03502707 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study on the Immune Response, Safety and the Occurrence of Respiratory Syncytial Virus (RSV)-Associated Respiratory Tract Illness After Administration of RSV OA Vaccine in Adults 60 Years and Older
NCT06551181 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Immunogenicity of RSVpreF Coadministered With SIIV in Adults ≥65 Years of Age
NCT05301322 ·Status: COMPLETED ·Phase: PHASE3
-
Clinical Lot Consistency for RSVpreF in a Population of Healthy Adults 18 to ≤49 Years of Age
NCT05096208 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Assess the Safety, Tolerability, and Immunogenicity of RSVpreF in Older Adults in Korea
NCT06593587 ·Status: COMPLETED ·Phase: PHASE3
-
A Study on the Immune Response and Safety of an RSV Vaccine When Given to Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant and Are at an Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease and Compared to Healthy Adults 50 Years of Age and Above
NCT05921903 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Learn About the Safety and Immune Activity of RSVpreF in Children 2 to <18 Years of Age
NCT05900154 ·Status: COMPLETED ·Phase: PHASE1
-
SPECIAL INVESTIGATION FOR ABRYSVO IN INDIVIDUALS AGED 60 YEARS OR OLDER
NCT06546800 ·Status: ACTIVE_NOT_RECRUITING
-
A Study to Investigate the Immunogenicity and Safety of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in High-risk Adults
NCT06067230 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Study on the Safety and Immune Response to an mRNA-based RSV Investigational Vaccine in Healthy Adults Aged 18-45 Years
NCT06573281 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a COVID-19 mRNA Vaccine in Adults Aged 50 Years and Above
NCT06374394 ·Status: COMPLETED ·Phase: PHASE3
-
RSV Immunogenicity Study in the Elderly (RISE)
NCT07203365 ·Status: RECRUITING ·Phase: PHASE3
-
A Follow-up Study to Describe the Safety of Study Participants Who Received RSVPreF3 Maternal Vaccination (Any Dose) or Controls From Previous RSV MAT Studies During Any Pregnancy Conceived Post Vaccination/Control
NCT05705440 ·Status: COMPLETED ·Phase: PHASE3