A Double-Blind, Randomized, Controlled, Multicenter Study to Evaluate the Safety, Tolerability and Immunogenicity of a Refrigerator-Stable Formulation of Zoster Vaccine Live (Oka/Merck)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 368
- 主要终点
- Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination
研究概览
简要总结
The purpose of this study is to determine whether the refrigerator-stable formulation of an investigational vaccine has a comparable immune response (the body's ability to protect against disease) and safety profile to that of the freezer-stable formulation of the vaccine.
详细描述
The duration of treatment is 4 weeks.
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
- •Individuals who are at least 50 years of age or older with a history of varicella (chicken pox)
排除标准
- •Prior history of herpes zoster (shingles)
- •Prior receipt of varicella or zoster vaccine
- •Immunosuppressed
研究组 & 干预措施
zoster vaccine live (Oka/Merck) refrigerated formulation
ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (~45,000 plaque-forming units [PFU]), 1 subcutaneous 0.65-mL injection
干预措施: Comparator: zoster vaccine live (Oka/Merck) refrigerated formulation (Biological)
zoster vaccine live (Oka/Merck) frozen formulation
ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (~57,000 PFU), 1 subcutaneous 0.65-mL injection
干预措施: Comparator: zoster vaccine live (Oka/Merck) frozen formulation (Biological)
结局指标
主要结局
Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination
时间窗: 4 weeks
The GMT of the VZV-specific antibody responses as measured by gpELISA (glycoprotein enzyme-linked immunosorbent assay) at 4 weeks postvaccination in subjects who received ZOSTAVAX™ with PGSU and in subjects who received ZOSTAVAX™ with PGS.
次要结局
- Vaccine-Related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination(4 weeks)