NCT02764671Unknown4 期
The Safety and Immunogenicity of 10μg/0.5ml Recombinant Hepatitis B Vaccines(Saccharomyces Cerevisiae) in the Healthy Neonates
Shenzhen Kangtai Biological Products Co., LTD2 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2015年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 5,000
- 试验地点
- 2
- 主要终点
- Number of subjects with adverse events
研究概览
简要总结
The purpose of this study is to further evaluate the immunogenicity and safety of 10μg/0.5ml Recombinant Hepatitis B Vaccines(Saccharomyces Cerevisiae) in the Healthy Neonates.
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
- — 至 24 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects who are healthy full-term infants after birth, Apgar score ≥8;
- •Subjects with a birth weight ≥ 2500g;
- •Subjects' guardians are able to understand and sign informed consent;
- •Subjects who can and will comply with the requirements of the protocol.
排除标准
- •Family history of eclampsia, epilepsy and encephalopathy;
- •Subjects' birth mother had immune system dysfunction, or history of organ transplantation or blood dialysis;
- •Subjects' parents had a medical history of allergic to any ingredient of the vaccine, including supplementary material and formaldehyde;
- •Subjects' parents had a medical history of allergic to combined hepatitis A and B vaccine(HAB) or hepatitis B vaccine;
- •Subjects had serious acute and chronic diseases;
- •with temperature ≧37.1℃;
- •Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives.
研究组 & 干预措施
10μg/0.5ml recombinant HBV vaccine
Experimental
5000 participants who are healthy neonates receive 10μg/0.5ml recombinant hepatitis B vaccine on day 0, 30 and 60.
干预措施: 10μg/0.5ml recombinant hepatitis B vaccine (Biological)
结局指标
主要结局
Number of subjects with adverse events
时间窗: Within 30 days after hepatitis B vaccination
次要结局
- Geometric mean titer of anti-hepatitis B virus surface antigen antibody(The 3th year after whole course of hepatitis B vaccination)
- Geometric mean titer of anti-hepatitis B virus surface antigen antibody(The 30th day after whole course of hepatitis B vaccination)
- Geometric mean titer of anti-hepatitis B virus surface antigen antibody(The 1th year after whole course of hepatitis B vaccination)
- Geometric mean titer of anti-hepatitis B virus surface antigen antibody(The 2th year after whole course of hepatitis B vaccination)
研究者
研究点 (2)
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