A PHASE 3, MULTICENTER, PARALLEL-GROUP, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF RESPIRATORY SYNCYTIAL VIRUS PREFUSION F SUBUNIT VACCINE WHEN COADMINISTERED WITH HERPES ZOSTER SUBUNIT VACCINE IN ADULTS ≥50 YEARS OF AGE
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 526
- 试验地点
- 26
- 主要终点
- Geometric Mean Ratio (GMR) of Neutralizing Titer (NTs) for RSV A and B in RSVpreF + herpes zoster subunit vaccine (HZ/su) Compared to RSVpreF Alone
研究概览
简要总结
This purpose of this phase 3 multicenter, parallel-group, open-label study is to learn about the safety, tolerability, and immunogenicity of RSVpreF and HZ/su vaccine when given together in adults 50 years of age and older.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Coadministration Group
- Visit 1 (Day 1): RSVpreF + HZ/su dose 1
- Visit 3 (Month 2): HZ/su dose 2
干预措施: RESPIRATORY SYNCYTIAL VIRUS PREFUSION F SUBUNIT VACCINE (Biological)
Coadministration Group
- Visit 1 (Day 1): RSVpreF + HZ/su dose 1
- Visit 3 (Month 2): HZ/su dose 2
干预措施: HZ/su VACCINE (Biological)
Sequential Administration Group
- Visit 1 (Day 1): HZ/su dose 1
- Visit 2 (Month 1): RSVpreF
- Visit 3 (Month 2): HZ/su dose 2
干预措施: RESPIRATORY SYNCYTIAL VIRUS PREFUSION F SUBUNIT VACCINE (Biological)
Sequential Administration Group
- Visit 1 (Day 1): HZ/su dose 1
- Visit 2 (Month 1): RSVpreF
- Visit 3 (Month 2): HZ/su dose 2
干预措施: HZ/su VACCINE (Biological)
结局指标
主要结局
Geometric Mean Ratio (GMR) of Neutralizing Titer (NTs) for RSV A and B in RSVpreF + herpes zoster subunit vaccine (HZ/su) Compared to RSVpreF Alone
时间窗: 1 month after vaccination with RSVpreF in the RSVpreF + HZ/su coadministration group to RSVpreF alone in the sequential administration group
Anti-gE antibody concentrations expressed as Geometric Mean Concentration (GMC) ratios in RSVpreF + HZ/su Compared to HZ/su Alone
时间窗: 1 month after the second dose of HZ/su in the RSVpreF + HZ/su coadministration group to HZ/su alone in the sequential administration group
Percentage of Participants reporting Local Reactions Within 7 Days after Vaccination
时间窗: Within 7 Days after each vaccination (Vaccination on Day 1)
Describe local reactions (redness, swelling, and pain at the injection site) within 7 days following each study intervention administration recorded by participants in an electronic diary (e-diary).
Percentage of Participants with Systemic Events Within 7 Days after Vaccination
时间窗: Within 7 Days after each vaccination (Vaccination on Day 1)
Describe systemic events (fatigue, headache, vomiting, nausea, diarrhea, muscle pain, and joint pain) within 7 days following each study intervention administration recorded by participants in an electronic diary (e-diary).
Percentage of Participants with Adverse Events (AEs)from Vaccination through 1 Month after Vaccination
时间窗: Within 1 Month after last vaccination
Describe AEs occurring through 1 month after each study intervention administration
Percentage of Participants with Serious Adverse Events (SAEs) Throughout the Study
时间窗: Within 4 Months after first study vaccination (Vaccination on Day 1)
Describe SAEs occurring through 4 months after the first study intervention administration.
次要结局
- NTs for RSV A and RSV B expressed as Geometric Mean Titers (GMT)(Before vaccination with RSVpreF, 1 month after vaccination with RSVpreF)
- NTs for RSV A and RSV B expressed as Geometric Mean Fold Rise (GMFR)(Before vaccination and 1 month after vaccination with RSVpreF)
- NTs for RSV A and RSV B expressed as seroresponse rate(1 month after vaccination with RSVpreF)
- Anti-gE antibody concentrations expressed as GMCs(Before vaccination and 1 month after the second dose of HZ/su)
- Anti-gE antibody concentrations expressed as GMFRs(Before vaccination and 1 month after the second dose of HZ/su)
- Anti-gE antibody concentrations expressed as seroresponse rate(1 month after the second dose of HZ/su)