EUCTR2015-001505-14-Outside-EU/EEA进行中（未招募）不适用
A phase III, randomized, controlled, single-blind study to evaluate the non-inferiority of GlaxoSmithKline Biologicals’ 10-valent pneumococcal conjugate vaccine compared to the 7-valent pneumococcal conjugate vaccine Prevenar™ when administered as a 3-dose primary immunization course at 2, 4 and 6 months of age, co-administered with GSK Biologicals’ Hiberix™ vaccine. - 10PN-PD-DIT-036
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 503
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 for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol.
- •Male or female subjects between, and including 6-12 weeks (42 to 90 days) of age at the time of the first vac-cination.
- •Written informed consent obtained from the parent(s) or guardian(s) of the subject.
- •Free of obvious health problems as established by medical history and clinical examination before entering into the study.
- •Born after a gestation period of 36 to 42 weeks inclusive, with a birth weight of at least 2.5 kg.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 503
- •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.
- •Planned administration/administration of a vaccine not allowed by the study protocol during the study period. Vaccines included in the Korean routine immunization schedule can be administered at least one week before or at least one month after the administration of the study vaccines. In addition, recommended live vaccines not in-cluded in the Korean routine immunization schedule can be given at least one month before or at least one month after the administration of the study vaccines.
- •A family history of congenital or hereditary immunodeficiency.
- •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 immunoglobulins at birth).
- •Previous vaccination against Streptococcus pneumoniae and/or Haemophilus influenzae type b.
- •History of, or intercurrent Streptococcus pneumoniae and/or Haemophilus influenzae type b disease.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •History of any neurological disorders or seizures.
- •Major congenital defects or serious chronic illness.
- •Acute disease at the time of enrolment.
研究者
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