EUCTR2014-000101-12-Outside-EU/EEA进行中（未招募）不适用
A phase III, multi-centre, double-blind, randomised study to assess the non-inferiority of a commercial lot of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate (10Pn-PD-DiT) vaccine compared to a clinical phase III vaccine lot, when given as a three-dose primary immunization course. - 10PN-PD-DIT-048 PRI
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 466
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 6-12 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 re-quirements of the protocol.
- •Written informed consent obtained from the parent(s)/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.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 466
- •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 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.
- •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, poliomyelitis, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae (with the exception of vaccines where the first dose can be given within the first two weeks of life).
- •Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting 30 days before each dose of vaccine and ending 7 days after Dose 1 and Dose 2 and 30 days after Dose 3.
- •History of, or intercurrent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, H. influenzae type b and rotavirus disease.
- •History of allergic disease or reactions likely to be exac-erbated 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.
- •Gastroenteritis within 7 days preceding the study vaccine administration.
- •Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract, intussusception or other medical condition determined to be serious by the investigator.
研究者
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