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临床试验/NCT01527370
NCT01527370已完成3 期

A Phase III Clinical Trial to Study the Safety, Tolerability, and Immunogenicity of ZOSTAVAX™ in Healthy Adults in India

Merck Sharp & Dohme LLC0 个研究点目标入组 250 人开始时间: 2012年10月31日最近更新:
适应症

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

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

研究者

申办方类型
Industry
责任方
Sponsor

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