EUCTR2013-003428-34-Outside-EU/EEA进行中（未招募）不适用
A phase IV, non-randomised, open-label, multicentre study with two parallel groups to assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ combined DTPa-HBV-IPV/Hib vaccine administered as a three-dose primary vaccination course at 2, 4 and 6 months of age in healthy infants in Canada. - DTPA-HBV-IPV-118 PRI
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
- 224
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 par-ent/guardian can and will comply with the requirements of the protocol should be enrolled in the study.
- •A male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination.
- •Born after a gestation period of 36 to 42 weeks inclusive.
- •Healthy subjects as established by medical history before entering into the study.
- •Written informed consent obtained from the parent or guardian of the subject.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 224
- •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 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 from birth until first primary vac-cination dose. For corticosteroids, this will mean predni-sone, or equivalent, more than or equal to 0.5 mg/kg/day. Inhaled and topical steroids are allowed.
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- •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).
- •Major congenital defects or serious chronic illness.
- •Evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and/or Hib vaccination or disease.
- •Any confirmed or suspected immunosuppressive or im-munodeficient condition, based on medical history.
- •History of allergic disease or reactions likely to be exac-erbated by any component of the vaccines.
- •The following condition is temporary or self limiting and a subject may be vaccinated once the condition has resolved and no other exclusion criteria are met:
- •Current febrile illness or axillary temperature of more than or equal to 37.5 ºC or other moderate to severe illness within 24 hours of study vaccine administration.
研究者
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