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.
None
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)
Single group
RSVpreF
Biological/VaccineRSV Vaccine
Percentage of participants reporting prompted local reactions within 7 days following investigational product administration
Describe prompted local reactions following investigational product administration
Percentage of participants reporting prompted systemic events within 7 days following investigational product administration
Describe prompted systemic events following investigational product administration
Percentage of participants reporting adverse events (AEs) through 1 month following investigational product administration
Describe AEs occurring through 1 month following administration of investigational product
Percentage of participants reporting serious adverse events (SAEs) throughout the study
Describe SAEs through 2 months following administration of investigational product
GMT of NTs for RSV A and RSV B
Describe the immune responses to RSVpreF with GMT of NTs for RSV A and RSV B before vaccination and at 1 month after vaccination.
Geometric mean fold rise (GMFR) of NTs for RSV A and RSV B
Describe the immune responses to RSVpreF with GMFR of NTs for RSV A and RSV B from before vaccination to 1 month after vaccination.
Seroresponse rate of NTs for RSV A and RSV B
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 ≥
