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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Pfizer
- 入组人数
- 130
- 试验地点
- 5
- 主要终点
- Percentage of participants reporting prompted local reactions within 7 days following investigational product administration
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
盲法说明
This is an open label study. Participant, investigators and other site staff, and sponsor staff will be unblinded to the participant's assigned study intervention.
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
RSVpreF
RSV Vaccine
干预措施: RSVpreF (Biological)
结局指标
主要结局
Percentage of participants reporting prompted local reactions within 7 days following investigational product administration
时间窗: Day 7
Describe prompted local reactions following investigational product administration
Percentage of participants reporting prompted systemic events within 7 days following investigational product administration
时间窗: Day 7
Describe prompted systemic events following investigational product administration
Percentage of participants reporting adverse events (AEs) through 1 month following investigational product administration
时间窗: 1 month after vaccination
Describe AEs occurring through 1 month following administration of investigational product
Percentage of participants reporting serious adverse events (SAEs) throughout the study
时间窗: 2 months after vaccination
Describe SAEs through 2 months following administration of investigational product
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
时间窗: 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
次要结局
- GMT of NTs for RSV A and RSV B(1 month after vaccination)
- Geometric mean fold rise (GMFR) of NTs for RSV A and RSV B(1 month after vaccination)
- Seroresponse rate of NTs for RSV A and RSV B(1 month after vaccination)