EUCTR2012-002427-15-Outside-EU/EEA进行中（未招募）不适用
A phase III, partially double-blind clinical trial to evaluate the immu-nogenicity and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ combined DTPa-HBV-IPV/Hib vaccine (new formulation) as compared with GSK Biologicals’ combined DTPa-HBV-IPV/Hib vaccine (current formulation) administered in healthy infants at 3, 4 and 5 months of age. The immunogenicity, safety and reactogenicity of the DTPa-HBV-IPV vaccine will also be evaluated in a third group of subjects. - DTPA-HBV-IPV-109
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 417
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- •A male or female between, and including, 11 and 17 weeks of age at the time of the first vaccination.
- •Infant born to known hepatitis B surface antigen seronegative mother.
- •Born after a normal gestation period.
- •Written informed consent obtained from the parent or guardian of the subject.
- •Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 417
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Use of any investigational or non-registered product 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.
- •Any confirmed or suspected immunosuppressive or im-munodeficient condition, based on medical history and physical examination.
- •A family history of congenital or hereditary immunodefi-ciency.
- •Major congenital defects or serious chronic illness.
- •History of any neurologic disorders or seizures.
- •Acute or chronic, clinically significant pulmonary, cardio-vascular, hepatic or renal functional abnormality, as determined by physical examination.
- •Hepatomegaly, right upper quadrant abdominal pain or tenderness.
- •Acute disease at the time of enrolment.
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- •Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
研究者
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