EUCTR2011-004644-22-Outside-EU/EEA进行中（未招募）不适用
A phase III, randomized, single-blind, controlled study to assess the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine as a 3-dose primary immunization course at 6, 10 and 14 weeks of age in India, co-administered with GSK Biologicals’ Tritanrix-HepB/Hib (DTPw-HBV/Hib) vaccine. - 10PN-PD-DIT-037 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
- 360
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
- •Male or female subjects between, and including 6-10 weeks of age at the time of the first vaccination.
- •Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol.
- •Written or oral, signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child/ward. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness.
- •Free of any known or suspected 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: 360
- •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 first dose of the study vaccines, or planned use 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).
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
- •A family history of congenital or hereditary immunodefi-ciency.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (with the exception of hepatitis B immuno-globulins at birth).
- •Previous vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae (with the exception of hepatitis B vaccination at birth or at least 30 days before the subject’s first study visit).
- •History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B, Streptococcus and Haemophilus influenzae type b disease.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- •History of any neurological disorders or seizures.
- •Major congenital defects or serious chronic illness.
- •Acute disease at the time of enrolment.
- •Babies for which birth weight is < 2 kilogram.
研究者
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