NCT00830648已完成4 期
Safety of a Second Dose of Biken's Varicella Vaccine Administered at 4 to 6 Years of Age in Healthy Children in Argentina
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- To provide information concerning the safety after administration of Varicella vaccine
研究概览
简要总结
The objective of the present study is to assess and document the safety of a second dose of Varicella Biken vaccine administered at 4 to 6 years of age in healthy children having previously received a first dose of Varicella Biken vaccine.
All subjects will receive a second dose of Varicella vaccine (Varicella Biken) at 4 to 6 years of age.
The expected total duration of follow-up (first visit to last visit) for each subject will be one month.
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
- 4 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination.
- •Planned participation in another clinical trial during the present trial period.
- •Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroids therapy.
- •Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances.
- •Chronic illness, at a stage that could interfere with trial conduct or completion, in the opinion of the investigator.
- •Receipt of any vaccine in the 4 weeks preceding the trial vaccination;
- •Planned receipt of any vaccine in the 4 weeks following the trial vaccination.
- •Known Human Immunodeficiency Virus (HIV), Hepatitis B surface antigen, or Hepatitis C seropositivity.
- •History of varicella infection (confirmed either clinically, serologically or microbiologically).
- •Previous vaccination against varicella disease with a vaccine different from Varicella Biken vaccine.
- •Febrile illness (temperature ≥ 37.5°C) or moderate or severe acute illness/infection on the day of vaccination, according to investigator judgment.
结局指标
主要结局
To provide information concerning the safety after administration of Varicella vaccine
时间窗: one month after vaccination
次要结局
未报告次要终点
研究者
研究点 (1)
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