NCT02152709已完成3 期
A Phase 3, Randomized, Controlled, and Blinded Clinical Trial to Evaluate Safety and Immunogenicity of 10µg/0.5ml Hepatitis B Vaccine for Infants and Other Age Groups.
Jiangsu Province Centers for Disease Control and Prevention1 个研究点 分布在 1 个国家目标入组 1,537 人开始时间: 2008年11月最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,537
- 试验地点
- 1
- 主要终点
- Number of subjects with adverse events
研究概览
简要总结
The main objective of this study was to evaluate the safety and immunogenicity of 10µg/0.5ml and 5µg/0.5ml hepatitis B vaccine made by recombinant deoxyribonudeic acid techniques in saccharomyces cereviside yeast for infants and other age groups.
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
- Single (Participant)
入排标准
- 年龄范围
- 1 Day 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of subjects with adverse events
时间窗: Within 28 days after hepatitis B vaccination
To analyze the number of subjects with adverse events within 28 days after administered each of hepatitis B vaccine.
Geometric mean concentration of anti-hepatitis B virus surface antigen antibody
时间窗: The 28th day after whole course of hepatitis B vaccination
Geometric mean concentration of anti-hepatitis B virus surface antigen antibody was measured by chemiluminescence assay and expressed with mIU/mL.
次要结局
- The rate of hepatitis B virus perinatal transmission(The 28th day after whole course of hepatitis B vaccination)
- Geometric mean concentration of anti-hepatitis B virus surface antigen antibody after the second dose of hepatitis B vaccination(The 28th day after the second of hepatitis B vaccination)
研究者
研究点 (1)
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