NL-OMON31293撤回4 期
A Phase IV Clinical Trial to Evaluate the Safety and Tolerability of ZOSTAVAX in Subjects >=60 Years of Age - Safety and Tolerability of ZOSTAVAX in Subjects >=60 Years of Age
适应症
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- Merck
- 入组人数
- 750
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •(see protocol page 20 for complete text of criteria);- Age >=60 Years
- •- Signed informed consent form
- •- Afebrile on day of vaccination
- •- Females must be postmenopausal or have negative pregnancy test
排除标准
- •(see protocol page 20 for complete text of criteria);1. A history of allergic reaction to any vaccine component
- •2. Prior receipt of any varicella or zoster vaccine.
- •3. Any live virus vaccine administered within 4 weeks prevaccination or scheduled
- •during the 42-day postvaccination period.
- •4. Any inactivated vaccine, except for influenza vaccine, administered within 7 days
- •prevaccination or scheduled during the 42-day postvaccination period
- •5. Subject is pregnant or breastfeeding.
- •6. Participation in an investigational drug or vaccine study within the last 30 days prior to enrollment or expected during the 42-day postvaccination period.
- •7. An intercurrent illness (including active untreated tuberculosis) that might interfere with the interpretation of the study
- •8. Use of immunosuppressive therapy.
- •9. Known or suspected immune dysfunction that is caused by a medical condition or any other cause. Subjects with a history of cancer who are not on active treatment and are not thought to be immunosuppressed at enrollment will be eligible for enrollment.
- •10. Any concomitant use of nontopical antiviral therapy with activity against
- •herpesviruses.
- •11. Any other reason that in the opinion of the investigator might interfere with the
- •evaluation required by the study.
研究者
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