NCT01684072已完成4 期
Evaluation of Safety and Immunogenicity Receiving Live Attenuated Vaccine Against Varicella Without Gelatin
Beijing Center for Disease Control and Prevention3 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2011年1月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,200
- 试验地点
- 3
- 主要终点
- To evaluate the immunogenicity of evaluated vaccine
研究概览
简要总结
The purpose of this study is to observe the occurrence of adverse reaction and antibody positive rate, the elevated level of antibody，Geometric mean titer (GMT) between groups of live attenuated varicella vaccine without gelatin.
详细描述
Observational Objectives:
To describe the safety of evaluated vaccine, in children aged ≥ 1th birthday and ≤ 12th birthday.
To describe the immunogenicity of evaluated vaccine, in children aged ≥ 1th birthday and ≤ 12th birthday.
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
- 1 Year 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parent/legal acceptable representative is willing and able to understand the protocol requirements and provide informed consent
- •Participant is considered to be in good health including the body and mental status on the basis of reported medical history and limited physical examination and live in local ≥ 12 months
- •Participant is aged ≥ 1 year to ≤ 12 years
- •Body temperature ≤ 37.0℃
- •Participant without preventive inoculation of varicella vaccine and previous history of chickenpox and zoster
排除标准
- •Known allergy to any constituent of the vaccine
- •Reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction
- •Known bleeding disorder
- •Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth
- •Participation in any other interventional clinical trial
- •An acute illness with or without fever (temperature > 37.0℃) in the latest week preceding enrollment in the trial
- •Inoculated other vaccines, immunoglobulin or investigational drugs within 4 weeks prior to participation in the study
- •Reported clearly the infection of the upper respiratory tract with 6 months
- •Clinical Manifestation of Metabolic, blood system, lungs, heart, the gastrointestinal tract, nervous system, kidneys, urinary system, endocrine, liver disease or malignant tumor
- •Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the vaccine
结局指标
主要结局
To evaluate the immunogenicity of evaluated vaccine
时间窗: 8 months
The immunologic equivalence of 4weeks after vaccination of influenza virus vaccine was measured in terms of the level of antibody.
次要结局
- To evaluate the safety of live attenuated varicella vaccine(4 months)
研究者
研究点 (3)
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