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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
130
RSV Vaccine
Tsuchiura Beryl Clinic
Tsuchiura, Ibaraki, Japan
RECRUITINGNihonbashi Sakura Clinic
Chuo-ku, Tokyo, Japan
RECRUITINGTokyo-Eki Center-building Clinic
Chuo-ku, Tokyo, Japan
RECRUITINGFukuwa Clinic
Chuo-ku, Tokyo, Japan
RECRUITINGTenjin Sogo Clinic
Fukuoka, Japan
RECRUITINGPercentage of participants reporting prompted local reactions within 7 days following investigational product administration
Describe prompted local reactions following investigational product administration
Time frame: Day 7
Percentage of participants reporting prompted systemic events within 7 days following investigational product administration
Describe prompted systemic events following investigational product administration
Time frame: Day 7
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
Time frame: 1 month after vaccination
Percentage of participants reporting serious adverse events (SAEs) throughout the study
Describe SAEs through 2 months following administration of investigational product
Time frame: 2 months after vaccination
Geometric Mean Titer (GMT) ratio (GMR) , estimated by the ratio of the GMTs for RSV subgroup A (RSV A) and RSV subgroup B (RSV B) neutralizing titers (NTs) with RSVpreF in this study's participants to that in Study C3671013 Japanese older adults
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
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.
Time frame: 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.
Time frame: 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 ≥
Time frame: 1 month after vaccination
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