RSVpreF
BiologicalRSV Vaccine
NCT Number: NCT07543380
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.
Interested in participating?
Request Info18 year–59 year
All sexes
Interventional
Phase 3
Tsuchiura Beryl Clinic, Tsuchiura, Ibaraki, Japan
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Please refer to the study contact for further eligibility details.
RSV Vaccine
Time frame: Day 7
Describe prompted local reactions following investigational product administration
Time frame: Day 7
Describe prompted systemic events following investigational product administration
Time frame: 1 month after vaccination
Describe AEs occurring through 1 month following administration of investigational product
Time frame: 2 months after vaccination
Describe SAEs through 2 months following administration of investigational product
Time frame: 1 month after vaccination
Demonstrate that the immune responses to RSVpreF in this study participant are similar to those in Study C3671013 Japanese older adults
Time frame: 1 month after vaccination
Describe the immune responses to RSVpreF with GMT of NTs for RSV A and RSV B before vaccination and at 1 month after vaccination.
Time frame: 1 month after vaccination
Describe the immune responses to RSVpreF with GMFR of NTs for RSV A and RSV B from before vaccination to 1 month after vaccination.
Time frame: 1 month after vaccination
Describe the immune responses to RSVpreF with seroresponse rate of NTs for RSV A and RSV B at 1 month after vaccination.
Seroresponse is defined as a postvaccination NT ≥4 times the lower limit of quantitation (LLOQ) if the baseline titer is below the LLOQ; or a ≥
Contact information is provided by the study sponsor or research team.
Pfizer
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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