A Phase III Double-Blinded, Randomized, Multicenter, Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of ZOSTAVAX™ Made With an Alternative Manufacturing Process (AMP)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 498
- 主要终点
- Geometric Mean Titer (GMT) of Varicella-Zoster Virus (VZV) Antibody
研究概览
简要总结
This study will determine whether ZOSTAVAX™ made with an alternative manufacturing process [ZOSTAVAX™ (AMP)] is well tolerated and immunogenic, and has a comparable immune response to ZOSTAVAX™.
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
- Double (Participant, Investigator)
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
- •No fever on day of vaccination
- •History of varicella or residence in a VZV-endemic area for ≥30 years
- •Females of reproductive potential must have a negative pregnancy test and must agree to use acceptable methods of birth control
排除标准
- •History of hypersensitivity reaction to any vaccine component
- •Prior receipt of any varicella or zoster vaccine
- •Prior history of herpes zoster
- •Have recently had another vaccination
- •Pregnant or breastfeeding
- •Use of immunosuppressive therapy
- •Known or suspected immune dysfunction
- •Concomitant antiviral therapy
研究组 & 干预措施
ZOSTAVAX™ (AMP)
ZOSTAVAX™ manufactured with an alternative process
干预措施: Zoster Vaccine, Live (AMP) (Biological)
ZOSTAVAX™
ZOSTAVAX™ manufactured with the current process
干预措施: Zoster Vaccine, Live (Biological)
结局指标
主要结局
Geometric Mean Titer (GMT) of Varicella-Zoster Virus (VZV) Antibody
时间窗: Day 1 and Week 6 postvaccination
VZV antibody titers were determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA)
Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers
时间窗: Day 1 (Baseline) to Week 6 postvaccination
VZV antibody titers were determined by gpELISA. The GMFR reports the geometric mean of the ratio of individual participant VZV antibody titers at Week 6 / Day 1 (Baseline).
次要结局
- Number of Participants With One or More Adverse Experiences (AEs)(Day 1 to Day 42 postvaccination)
- Number of Participants With One or More Serious Adverse Experience (SAE) Day 1 to 42 Postvaccination(Day 1 to Day 42 postvaccination)
- Number of Participants With One or More Serious Adverse Experience Day 1 to 182 Postvaccination(Day 1 to Day 182 postvaccination)