NCT00444860已完成3 期
A Phase III Clinical Trial to Study the Safety, Tolerability, and Immunogenicity of ZOSTAVAX(R) in Healthy Adults in Taiwan
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
- 主要终点
- The geometric mean fold rise (GMFR) of subjects VZV antibody titers from prevaccination to 4 weeks postvaccination, and the geometric mean titers (GMTs) at prevaccination and 4 weeks postvaccination, as measured by gpELISA, will be assessed.
研究概览
简要总结
The purpose of this study is to obtain safety and immunogenicity data for the refrigerator-stable formulation of ZOSTAVAX(R) in taiwanese adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Subject Is Older Than 50 Years Of Age On Day Of Signing Informed Consent
- •All Females Must Be Postmenopausal Or Have A Negative Serum Or Urine Pregnancy Test
- •Postmenopausal Is Defined As 6 Months Of Spontaneous Amenorrhea With Serum Follicle Stimulating Hormone (Fsh) Levels In The Postmenopausal Range As Determined By The Laboratory, Or 12 Months Of Spontaneous Amenorrhea
- •A Subject Who Is Of Reproductive Potential Must Agree To Remain Abstinent Or Use (Or Have Her Partner Use) 2 Acceptable Methods Of Birth Control For Three Months After Vaccination
- •Acceptable Methods Of Birth Control Are: Intrauterine Device, Diaphragm With Spermicide, Contraceptive Sponge, Oral Contraceptive Pills, Condom, Tubal Ligation, And Vasectomy
- •Subject Must Sign Informed Consent Prior To Any Study Procedure
- •Subject Must Be afebrile (<38.3 °C Oral) On Day Of Vaccination
- •Any Underlying Chronic Illness Must Be In Stable Condition
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
Zostavax
干预措施: Zoster Vaccine, Live, (Oka-Merck) (Biological)
结局指标
主要结局
The geometric mean fold rise (GMFR) of subjects VZV antibody titers from prevaccination to 4 weeks postvaccination, and the geometric mean titers (GMTs) at prevaccination and 4 weeks postvaccination, as measured by gpELISA, will be assessed.
时间窗: prevaccination and 4 weeks postvaccination
次要结局
未报告次要终点
研究者
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