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临床试验/NCT01861613
NCT01861613已完成4 期

Seroprevalence of Hepatitis B and Immune Response to Hepatitis B Vaccination in Chinese College Students

Hui Zhuang1 个研究点 分布在 1 个国家目标入组 2,040 人开始时间: 2009年9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
2,040
试验地点
1
主要终点
Anti-HBs immune response in participants negative for HB sAg, anti-HBs and anti-HBc

研究概览

简要总结

At present, children less than 15 y of age have been regarded as a key group for hepatitis B immunization in China. However, there is not yet special immunization strategy for population above 15 y of age. In this study, we investigated the seroprevalence of hepatitis B and immune response to HB vaccine among Chinese college students to uncover the need on universal mass vaccination or booster immunization only for students with HBV vaccination history against hepatitis B in Chinese college students to inform decision making.

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
16 Years 至 30 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female freshmen in one college in Liuzhou city of Guangxi Zhuang Autonomous Region

排除标准

  • for vaccination study:
  • acute illness
  • immunocompromised conditions
  • renal insufficiency
  • pregnancy
  • allergic history to HB vaccine or yeast
  • positive for any of HBsAg, anti-HBs or anti-HBc

结局指标

主要结局

Anti-HBs immune response in participants negative for HB sAg, anti-HBs and anti-HBc

时间窗: Anti-HBs was assayed at Month 7

次要结局

  • Seroprevalence for HBsAg, anti-HBs and anti-HBc in Chinese college students(seroprevalence at baseline)
  • Anti-HBs immune response in participants negative for HBsAg, anti-HBs and anti-HBc(Anti-HBs immune response at Month 20)

研究者

发起方
Hui Zhuang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hui Zhuang

Professor

Peking University

研究点 (1)

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