NCT00320463已完成3 期
Compare Immunogenicity & Reactogenicity of 2 Formulations of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine (New vs Current) Given in Healthy Infants. The DTPa-HBV-IPV Vaccine (New Formulation) Will Also be Assessed in a 3rd Group of Subjects
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 415
- 试验地点
- 4
- 主要终点
- One month after vaccination, measurement of antibodies against all vaccine antigens.
研究概览
简要总结
In this study, infants will be randomly allocated into three groups:
- one group of subjects will receive DTPa-HBV-IPV/Hib vaccine (new formulation)
- the second group of subjects will receive DTPa-HBV-IPV/Hib vaccine (current formulation)
- the third group of subjects will receive DTPa-HBV-IPV vaccine The study will be double-blind for the two groups receiving the DTPa-HBV-IPV/Hib vaccine (new or current formulation). The study will be single-blind for the group receiving DTPa-HBV-IPV vaccine.
详细描述
A study to compare the immunogenicity & safety of 2 formulations of GlaxoSmithKline (GSK) Biologicals' DTPa-HBV-IPV/Hib vaccine given in healthy infants at 3,4 & 5 months age. The immunogenicity & safety of DTPa-HBV-IPV vaccine will also be evaluated in a 3rd group of subjects Subjects in the group that will receive DTPa-HBV-IPV/Hib vaccine (current formulation) will be the control group for the group that will receive DTPa-HBV-IPV/Hib vaccine (new formulation)
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
- Double
入排标准
- 年龄范围
- 11 Weeks 至 17 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •"Inclusion criteria:
- •A healthy male or female infant between, and including, 11 and 17 weeks of age at the time of the first vaccination.
- •Infant born to known hepatitis B surface antigen (HBsAg) seronegative mother (documented laboratory result of HBsAg assay from the maternal blood sample is available).
- •Born after a normal gestation period (between 36 and 42 weeks).
- •Written informed consent obtained from the parent or guardian of the subject.
排除标准
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- •Any chronic drug therapy to be continued during the study period.
- •Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccine and ending 30 days after the last vaccine dose.
- •Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and/or Haemophilus influenzae diseases.
- •Known history of or exposure to diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and/or Haemophilus influenzae diseases since birth.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
结局指标
主要结局
One month after vaccination, measurement of antibodies against all vaccine antigens.
次要结局
- Immunogenicity: One month after vaccination, vaccine response for the pertussis antigens.
- Reactogenicity & safety: After each dose, solicited (day 0-3, local & general) & unsolicited (day 0-30) symptoms. Over the full course of the study: serious adverse events (SAEs)."
研究者
研究点 (4)
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