A Phase III Clinical Trial to Study the Safety, Tolerability, and Immunogenicity of ZOSTAVAX™ in Healthy Adults in India
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 250
- 主要终点
- Number of Participants With Serious Adverse Events
研究概览
简要总结
This study will determine if ZOSTAVAX™ is safe, tolerable, and immunogenic in healthy adults in India.
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
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
- •Females have a negative pregnancy test and use an acceptable method of birth control, or are postmenopausal
- •Underlying chronic illnesses must be stable
排除标准
- •History of hypersensitivity reaction to any vaccine component
- •Prior receipt of a varicella or zoster vaccine
- •Prior history of herpes zoster
- •Have recently had another vaccination
- •Have recently received blood products other than autologous blood transfusion
- •Pregnant or breast feeding
- •Use of immunosuppressive therapy
- •Known or suspected immune dysfunction
- •Use of nontopical antiviral therapy with activity against herpesvirus
结局指标
主要结局
Number of Participants With Serious Adverse Events
时间窗: Up to 42 days postvaccination
A serious adverse event is one that results in death, is life-threatening, results in a persistent or significant disability, results in or prolongs hospitalization, results in a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgment.
The Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody at 6 Weeks Postvaccination
时间窗: Prevaccination up to 6 weeks postvaccination
Antibody titers were measured by VZV-specific glycoprotein enzyme-linked immunosorbent assay (gpELISA).
Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers at 6 Weeks Postvaccination
时间窗: Prevaccination up to 6 weeks postvaccination
GMFR was analyzed as the geometric mean of the ratio of VZV antibody titer (gpELISA units/mL) at postvaccination week 6 over VZV antibody titer (gpELISA units/mL) at prevaccination day 1.
次要结局
未报告次要终点