NCT00546819已完成2 期
A Phase IIb Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of Zoster Vaccine Live (Oka/Merck) in Patients on Chronic/Maintenance Corticosteroids
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 309
- 主要终点
- Number of Participants With Serious Adverse Events (SAE)
研究概览
简要总结
The purpose of the study was to assess the safety, tolerability, and immunogenicity of ZOSTAVAX™ in patients receiving chronic/maintenance corticosteroids.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Varicella-history positive, herpes zoster (HZ)-history negative patients
- •60 years of age and older receiving chronic/maintenance systemic corticosteroid therapy at a daily dose of 5 to 20 mg of prednisone or equivalent for at least the 2 weeks immediately prior to enrollment and expected to continue to receive a daily dose of 5 to 20 mg of prednisone or equivalent for the 6-week primary safety follow-up period (dose may vary within this range during the 6-week postvaccination period)
- •All females enrolling must be postmenopausal
排除标准
- •Patients with a history of hypersensitivity reaction to gelatin or neomycin
- •Prior receipt of varicella or zoster vaccine; prior history of herpes zoster
- •Immune globulin and/or blood products given within 5 months prior to or expected within the 6-week postvaccination period
- •Receipt of any live virus vaccinations within 1 month or receipt of any inactivated vaccinations within 7 days prior to enrollment
- •Known immune deficiency that is caused by a medical condition
- •Any use in the 8 weeks prior to vaccination or for 6 weeks after vaccination other medications which may suppress the immune system including methotrexate, corticosteroids at a daily dose greater than 20 mg of prednisone or equivalent, agents used to treat cancer, or medications which alter the level of the immune response used to treat arthritis or other illnesses
- •Concomitant use of antiviral therapy
- •A history of alcohol abuse or recreational drug use
结局指标
主要结局
Number of Participants With Serious Adverse Events (SAE)
时间窗: Up to 182 days postvaccination
A serious adverse event is defined as any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgement.
次要结局
- Geometric Mean Titer (GMT) of Varicella-Zoster Virus (VZV) Antibodies at 42 Days Postvaccination(42 days postvaccination)
- Geometric Mean Fold Rise (GMFR) of the VZV Antibody Response From Day 1 to Day 42 Postvaccination.(42 days postvaccination)
研究者
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