NCT00197158已完成4 期
Demonstrate the Non-inferiority of Immunogenicity Elicited by GSK Biologicals' Hepatitis B Vaccine, Multidose Engerix™-B to That of Monodose Engerix™-B When Administered According to 0,1,6 Mths Schedule in Healthy Adults Aged ≥ 18 Yrs
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 280
- 试验地点
- 2
- 主要终点
- Measurement of antibody concentrations to hepatitis B antigen at Month 7.
研究概览
简要总结
GSK Biologicals' currently licensed multidose hepatitis B vaccine will be compared to the currently licensed monodose hepatitis B vaccine in a population with well documented hepatitis B immunological response to the vaccine (Belgium).
详细描述
Randomized study with two groups. One group will receive GSK's multidose hepatitis B vaccine and the other group will receive GSK's monodose hepatitis B vaccine
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
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Measurement of antibody concentrations to hepatitis B antigen at Month 7.
次要结局
- Measurement of antibody concentrations to hepatitis antigen at Months 1,2and6. Occurrence of solicited local symptoms and solicited general symptoms during the 4-day f/u period after vaccination. Occurrence, intensity and relationship to vaccination
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
Study on New Strategies for Hepatitis B Virus ImmunizationVaccine ReactionNCT06515938Wu Jiang1,169
已完成
3 期
Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza (H1N1 Influenza Virus) Vaccine in Adults, Using Two Different Manufacturing ProcessesInfluenzaNCT00992511GlaxoSmithKline300
已完成
3 期
Primary & Booster Study in Infants to Demonstrate Non-inferiority, Persistence & Immunogenicity of Hib-MenC VaccineNeisseria MeningitidisHaemophilus Influenzae Type bNCT00327184GlaxoSmithKline709
已完成
2 期
Safety and Immunogenicity of GSK Bio's Candidate HBV-MPL Vaccines Compared to Engerix™-B, in Healthy AdolescentsHepatitis BNCT00697775GlaxoSmithKline200