EUCTR2012-002428-34-Outside-EU/EEA进行中（未招募）不适用
A phase IV, partially double-blind, multicentre study to assess the immunogenicity 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) when administered as a booster dose to children aged 18-23 months, previously primed with the same vaccines in primary vaccination study DTPa-HBV-IPV-109 (105910). The immunogenicity and reactogenicity of a booster dose of the DTPa-HBV-IPV vaccine will be evaluated in a third group of subjects who had received this vaccine in the primary study. - DTPA-HBV-IPV-117 BST:109
GlaxoSmithKline Biolgicals0 个研究点目标入组 283 人开始时间: 2015年4月30日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 283
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.
- •Subjects must have completed full three-dose primary vaccination course with DTPa-HBV-IPV/Hib (new formulation/ current formulation) or DTPa-HBV-IPV in the primary study DTPa-HBV-IPV-109 (105910).
- •A male or female between, and including 18 and 23 months of age at the time of the booster vaccination.
- •Written informed consent obtained from the parent or guardian of the subject.
- •Healthy subjects 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: 283
- •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 (drug or vaccine) other than the study vaccines within 30 days preceding the booster 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 within six months prior to the booster dose. (For corticos-teroids, this will mean prednisone, or equivalent, more than 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
- •Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the booster dose.
- •Participation in another clinical study, between the primary study DTPa-HBV-IPV-109 (105910) and the present booster study, or at any time during the study, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- •Previous booster vaccination against diphtheria, tetanus, pertussis, poliomyelitis and hepatitis B since the conclusion visit of study DTPa-HBV-IPV-109 (105910).
- •Previous booster vaccination against Haemophilus influ-enzae diseases in the DTPa-HBV-IPV/Hib groups, since the conclusion visit of study DTPa-HBV-IPV-109 (105910).
- •History of exposure to diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and/or Haemophilus influenzae disease since the conclusion visit of study DTPa-HBV-IPV-109 (105910).
- •Any confirmed or suspected immunosuppressive or im-munodeficient condition, based on physical examination (no laboratory testing required).
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- •Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. Axillary temperature < 37.5°C.
- •Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
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