A PHASE 3, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF REVACCINATION WITH RESPIRATORY SYNCYTIAL VIRUS STABILIZED PREFUSION F SUBUNIT VACCINE (RSVPREF) IN IMMUNOCOMPROMISED ADULTS
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Pfizer
- 入组人数
- 440
- 试验地点
- 6
- 主要终点
- Percentage of participants reporting systemic events
研究概览
简要总结
The purpose of this phase 3 study is to learn the safety, tolerability and immunogenicity of revaccination with RSVpreF at approximately 1-, 2-, and 3-year intervals to inform the revaccination interval in immunocompromised adults.
This study is seeking participants who are 18 years of age and older and will be grouped based on prior RSV vaccination history. Participants are required to be immunocompromised per study protocol.
All participants in this study will receive 1 shot to their arm of a RSVPreF vaccine.
Participants will take part in this study for about 12 months and will need to visit the clinical study site at least 4 times.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants ≥18 years of age who are/were immunocompromised at the time of initial RSVpreF vaccination, per study protocol, and will be grouped based on prior RSV vaccination history:
- •Group 1 will include participants naïve to any RSV vaccine.
- •Group 2 will include participants who received a single prior dose of RSVpreF (Abrysvo) approximately 1 year (9 to 15 months) prior to enrollment.
- •Group 3 will include participants who received a single prior dose of RSVpreF (Abrysvo) approximately 2 years (21 to 27 months) prior to enrollment.
- •Group 4 will include participants who previously received 2 doses of RSVpreF in Study C3671023 Substudy B approximately 3 years (36 to 42 months) prior to enrollment.
- •Participants should have a life expectancy ≥12 months (365 days) in the opinion of the investigator at enrollment.
排除标准
- •Prior history of any subtype of Guillain-Barré Syndrome (GBS) of any etiology.
- •History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any components of the study intervention(s).
- •Participants with a history of transplant rejection, or PTLD, or participants who have had treatment for these conditions, within 90 days prior to study enrollment or suspected chronic humoral or cellular rejection.
- •Receipt of B-cell depleting therapies within 180 days prior to initial study vaccination.
- •Refer to the study contact for further eligibility details.
研究组 & 干预措施
Group 1
RSVpreF Vaccine
干预措施: RSVpreF Vaccine (Biological)
Group 3
RSVpreF Vaccine
干预措施: RSVpreF Vaccine (Biological)
Group 4
RSVpreF Vaccine
干预措施: RSVpreF Vaccine (Biological)
Group 2
RSVpreF Vaccine
干预措施: RSVpreF Vaccine (Biological)
结局指标
主要结局
Percentage of participants reporting systemic events
时间窗: For up to 7 days after vaccination
Percentage of participants reporting adverse events
时间窗: Through 1 month after vaccination
Percentage of participants reporting newly diagnosed chronic medical conditions
时间窗: Through 12 months after vaccination
Percentage of participants reporting local reactions
时间窗: For up to 7 days after vaccination
Percentage of participants reporting serious adverse events
时间窗: Through 12 months after vaccination
Neutralizing Titers (NTs) for RSV A and RSV B expressed as Geometric Mean Titer (GMT)
时间窗: Before vaccination, 1 month, 6 months and 12 months after vaccination
NTs for RSV A and RSV B expressed as Geometric Mean Fold Rise (GMFR)
时间窗: Before vaccination, 1 month, 6 months and 12 months after vaccination
次要结局
- Seroresponse rate of NTs for RSV A and RSV B(1 month after revaccination)