EUCTR2015-001510-10-Outside-EU/EEA进行中（未招募）不适用
A phase III, single group, open study to assess the immunogenicity, safety and reactogenicity of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine in Mexico when co-administered with GSK Biologicals’ Infanrix hexa (DTPa-HBV-IPV/Hib) vaccine as a 3-dose primary immunization course at 2, 4 and 6 months of age and GSK Biologicals’ Rotarix vaccine (HRV) as a 2-dose primary immunization course at 2 and 4 months of age. - 10PN-PD-DIT-029
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 230
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 (42-90 days) of age at the time of the first vaccina-tion.
- •Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
- •Written informed consent obtained from the parent or guardian 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.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 230
- •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 vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting one month (30 days) before each dose of vaccines and ending 7 days after dose 1 and dose 2 and one month af-ter dose 3.
- •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 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.
- •Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, rotavirus and/or Streptococcus pneumoniae (with the exception of vaccines where the first dose may be given within the first two weeks of life according to the national recommendations).
- •History of, or intercurrent, diphtheria, tetanus, pertussis, polio, hepatitis B and Haemophilus influenzae type b disease.
- •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.
- •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.
研究者
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