NCT01815073已完成4 期
A Study to Evaluate the Immunogenicity and Safety of Live Attenuated Varicella Vaccine Combined With Live Attenuated JE Vaccine
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 497
- 试验地点
- 1
- 主要终点
- Seroconversion rate and GMTs for live attenuated varicella vaccine, live attenuated JE vaccine and live attenuated varicella vaccine combined with live attenuated JE vaccine, respectively.
研究概览
简要总结
The purpose of this study is to observe the occurrence of adverse events and seroconversion rate, geometric mean titres (GMTs) of live attenuated varicella vaccine，live attenuated JE vaccine and live attenuated varicella vaccine combined with live attenuated JE vaccine, respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 3 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 aged ≥ 1 year to ≤ 3 years
- •Participant without previous history of chickenpox, zoster and epidemic encephalitis B
- •Subject and parent/guardian able to attend all scheduled visits and comply with all trial procedures
- •Body temperature ≤ 37.5℃
排除标准
- •Known allergy to any constituent of the vaccine
- •Known acute illness, severe chronic disease, acute exacerbation of chronic disease and fever
- •Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth
- •Reported the history of allergies, convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction
- •Failed to the Expanded Programme on Immunization(EPI)
- •Receipt of any vaccine in the 4 weeks preceding the trial vaccination
- •Plan to receive any vaccine in the 4 weeks following the trial vaccination
- •Known bleeding disorder
- •Receipt of whole blood, blood plasma or immunoglobulin in the 5 months preceding the trial vaccination
- •Reported the history of acute illness had need systemic antibiotics or anti-viral treatment of infections in the 7 days preceding the trial vaccination
- •An acute illness with or without fever (temperature ≥ 38.0℃) in the 3 days preceding enrollment in the trial
- •Participation in any other interventional clinical trial
- •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
Seroconversion rate and GMTs for live attenuated varicella vaccine, live attenuated JE vaccine and live attenuated varicella vaccine combined with live attenuated JE vaccine, respectively.
时间窗: 35-42 days after vaccination
次要结局
- Occurrence of adverse events.(within 30 days after each vaccination)
研究者
研究点 (1)
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