NCT00216229Unknown4 期
A Study Comparing the Effectiveness of Two Different Vaccination Schedules of the Combined Hepatitis A and B Vaccine(Twinrix Adult1440/20)
IDEWE Occupational Health Services2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2004年9月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Anti-HBs antibodies concentration 1 month after 3th vaccine dose
研究概览
简要总结
To compare the efficiency of protection against hepatitis-B virus by administration of the combined vaccine against hepatitis A and B using the schedule 0-1-12 months against the schedule 0-1-6 months.
- To compare the seroconversion (>= 1 IU/l) and seroprotection (>= 10 IU/l) rate at month 6,7,12 and 13.
- To compare the distribution of anti-HBs at these different moments.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years or older;
- •a good physical condition as confirmed by history and physical examination at entry of the study;
- •for female participants who could become pregnant in the course of the study a contraceptive programme is foreseen;
- •all participants have provided written informed consent.
排除标准
- •Employees occupationally exposed to hepatitis B virus
- •Other exclusion criteria listed for the vaccine (licensed vaccine):
- •Each acute disease at the inclusion in the study;
- •A history of hypersensibility to one of the components of the vaccine;
- •Simultaneous participation in another clinical trial
结局指标
主要结局
Anti-HBs antibodies concentration 1 month after 3th vaccine dose
次要结局
- Natural evolution of anti-HBs antibodies concentration between 2nd and 3th vaccine dose (5-11 months)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
3 期
Immunogenicity and Safety of an Adjuvanted HBV Vaccine Compared to Engerix™-B, in a Non-responder Population ≥ 15yHepatitis BNCT00698061GlaxoSmithKline145
已完成
不适用
Comparison of effectiveness of hepatitis B revaccination schemes in healthy non-respondershepatitis B vaccine non-response10047438NL-OMON41474eids Universitair Medisch Centrum480
进行中（未招募）
1 期
Comparison of 4 different Hepatitis B vaccines in healthy persons in whom a standard hepatitis B vaccination schedule of three vaccinations did not induces a protective immune response, so-called non-responders.EUCTR2011-005627-40-NL480
已完成
4 期
Strategies for the Prevention of Hepatitis B Among HIV Infected Patients in UgandaHIV/AIDS and InfectionsNCT02316444Fred Hutchinson Cancer Center132
已完成
不适用
Comparing 2 methods of HBV vaccination in HIV positive patientsHuman Immunodeficiency Virus.Asymptomatic human immunodeficiency virus [HIV] infection status- Viral vaccinesZ21-Y59.0IRCT2013122415878N2Pasteur Institute of Iran150