NCT07543380 A Study to Learn Safety and Immune Response to Study Vaccine -RSVpreF in Adults at High Risk of Severe RSV Disease.
| NCT ID | NCT07543380 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Pfizer |
| Condition | Respiratory Syncytial Virus (RSV) |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2026-05-11 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 130 participants in total. It began in 2026-05-11 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Pfizer CT.gov Call Center
STUDY DIRECTOR
Pfizer
Frequently Asked Questions
Who can join the NCT07543380 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 59 Years, studying Respiratory Syncytial Virus (RSV). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07543380 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 130 participants.
Is NCT07543380 currently recruiting?
Yes, NCT07543380 is actively recruiting participants. Contact the research team at ClinicalTrials.gov_Inquiries@pfizer.com for enrollment information.
Where is the NCT07543380 trial being conducted?
This trial is being conducted at Tsuchiura, Japan, Chuo-ku, Japan, Chuo-ku, Japan, Chuo-ku, Japan and 1 additional location.
Who is sponsoring the NCT07543380 clinical trial?
NCT07543380 is sponsored by Pfizer. The principal investigator is Pfizer CT.gov Call Center at Pfizer. The trial plans to enroll 130 participants.