NCT00432731已完成4 期
A Double-blind, Randomised, Controlled, Multi-centre Safety Study of a Refrigerator-stable Formulation of VARIVAX® in Healthy 12 to 15 Month-old Infants.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 25
研究概览
简要总结
Primary objective:
To describe the safety profile of a refrigerator-stable formulation of VARIVAX® as a first single dose injection in 12 to 15 month-old infants in the 42-day follow-up period post-vaccination.
Secondary objectives: NA
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double
入排标准
- 年龄范围
- 12 Months 至 15 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infants from 12 months of age to 15 months of age.
- •Consent form signed by both parents or by the legal representative(s), properly informed about the study,
- •Parent(s) able to understand the protocol requirements and to fill in the Diary Card.
排除标准
- •Prior receipt of measles, mumps, rubella or varicella vaccine either alone or in combination vaccine,
- •Known or suspected clinical history of infection with measles, mumps, rubella, varicella or zoster,
- •Any known recent (≤30 days) exposure to measles, mumps or rubella,
- •Any known recent (≤30 days) exposure to varicella or zoster involving:
- •Any recent (≤3 days) history of febrile illness (rectal temperature ≥38.0°C),
- •Active untreated tuberculosis,
- •Any known blood dyscrasia, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems,
- •Any immune impairment or humoral/cellular deficiency, neoplastic disease or depressed immunity,
- •Any previous (≤150 days) receipt of immune serum globulin or any blood-derived products or scheduled to be administered through visit 3,
- •Any recent receipt of an inactivated or a live vaccine (≤ 30 days) or scheduled vaccination through visit 3
研究者
研究点 (25)
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