NCT00879827已完成3 期
Immunogenicity and Reactogenicity of GSK Biologicals' DTPa-HBV-IPV and Hib Vaccines When Administered Concomitantly to Healthy Infants Administered as a Three-dose Primary Vaccination Course at the Age of 1.5, 3.5 and 6 Months
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Anti-PT, anti-FHA and anti-PRN antibody titers.
研究概览
简要总结
The purpose of this study is to evaluate the immune response and reactogenicity of GSK Biologicals' DTPa-HBV-IPV combined pentavalent vaccine and Hib tetanus conjugate vaccine, administered concomitantly as a three-dose primary vaccination course.
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
- 6 Weeks 至 8 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A male or female infant between 6 and 8 weeks of age at the time of the first vaccination.
- •Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- •Written informed consent obtained from the parents or guardians of the subject.
- •Born after a normal gestation period (between 36 and 42 weeks).
排除标准
- •Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine.
- •Administration of chronic immunosuppressants or other immune-modifying drugs since birth or planned administration during the study.
- •Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine(s) and ending 30 days after.
- •Previous vaccination against diphtheria, tetanus, pertussis, polio or Haemophilus influenzae type b.
- •History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B, polio and/or Haemophilus influenzae type b.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
- •Major congenital defects
- •Serious chronic illness
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- •Acute disease at the time of enrollment.
结局指标
主要结局
Anti-PT, anti-FHA and anti-PRN antibody titers.
时间窗: One month after the 3rd dose of the primary vaccination course
Anti-HBs antibody titers
时间窗: One month after the 3rd dose of the primary vaccination course
Anti-PRP antibody titers
时间窗: One month after the 3rd dose of the primary vaccination course
Anti-diphtheria toxoid and anti-tetanus toxoid antibody titers
时间窗: One month after the 3rd dose of the primary vaccination course
Anti-polio virus types 1, 2 and 3 antibody titers
时间窗: One month after the 3rd dose of the primary vaccination course
次要结局
- Occurrence of solicited adverse events(During the 4-day follow-up period after each dose)
- Occurrence of unsolicited adverse events(During the 30-day follow-up period after each dose)
- Occurrence of Serious Adverse Events(Over the course of the study)
研究者
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