NCT00376779已完成2 期
A Phase II, Observer-blind, Randomized Study to Evaluate the Immunogenicity, Safety and Reactogenicity of GlaxoSmithKline (GSK) Biologicals' Combined DssiTgdPa-HBV-IPV/Hib Vaccine Containing Diphtheria Toxoid From the Statens Serum Institute (SSI) of Denmark and Tetanus Toxoid From GSK Biologicals' Kft [GD], Compared to the Currently Licensed GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine (Infanrix Hexa TM) When Administered to Healthy Infants at 2, 3 and 4 Months of Age.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 450
- 试验地点
- 7
- 主要终点
- Antibody concentration/response to all vaccine antigens after vaccination
研究概览
简要总结
The purpose of this study is to show that the immunogenicity of newly formulated DTPa-HBV-IPV/Hib vaccine is as good as the immunogenicity of the currently licensed formulation of the vaccine. The vaccine will be administered as a primary vaccination course to healthy infants at 2, 3 and 4 months of age and its safety and reactogenicity will also be assessed.
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
- 8 Weeks 至 12 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A healthy male or female between, and including, 8 and 12 weeks of age at the time of the first vaccination.
- •Written informed consent obtained from the parents/guardians of the subject.
- •Born after a normal gestation period of 36 to 42 weeks.
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 (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs from birth until first primary vaccination dose.
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- •Administration/planned administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the first dose and ending 30 days after the last dose, with the exception of the human rotavirus (HRV) vaccine.
- •Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- •Evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B and/or Haemophilus influenza type b (Hib) vaccination or disease.
- •Hepatitis B virus (HBV) vaccination at birth.
- •History of seizures or progressive neurological disease.
结局指标
主要结局
Antibody concentration/response to all vaccine antigens after vaccination
次要结局
- Solicited (D0-3); unsolicited events (D0-30); serious adverse events (SAEs) (full study)
研究者
研究点 (7)
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