EUCTR2012-002727-15-Outside-EU/EEA进行中（未招募）不适用
A phase II, randomized, controlled, observer-blind study to evaluate the impact of two formulations of GlaxoSmithKline (GSK) Biologicals’ combined 10-valent pneumococcal polysaccharide and non-typeable Haemophilus influenzae protein D conjugate and pneumococcal protein vaccine on nasopharyngeal carriage, safety and immunogenicity when co-administered with routine EPI vaccines in infants following safety assessment in children aged 2-4 years in The Gambia. - SPNG-005
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,320
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
- •Inclusion criteria for subjects in Cohort 1 (children) and Cohort 2 (infants):
- •Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol
- •Male or female between, and including,
- •- 2 to 4 years of age at the time of the first vaccination for subjects in Cohort 1 (children).
- •- 8 to 10 weeks (56-76 days) of age at the time of the first vaccination for subjects in Cohort 2 (infants).
- •Signed or thumb-printed informed consent obtained from the parents/LAR(s) of the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Permanent residence in the study area and no intention of leaving during the study period.
- •Additional inclusion criteria for subjects in Cohort 1:
- •Previously completed three-dose primary course of diphtheria-tetanus-pertussis (DTP) vaccination.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1320
- •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
- •Exclusion criteria for subjects in Cohort 1 (children) and Cohort 2 (infants):
- •Child in care.
- •Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- •Planned administration/administration of a vaccine not foreseen by the study protocol during the study period starting from 30 days before each dose and ending 30 days after each dose of vaccine(s), with the exception of licensed flu vaccines or other vaccines recommended as part of a national campaign (e.g. Polio, Measles or Meningococcal Vaccines).
- •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
- •Previous vaccination against S. pneumoniae.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •Malnutrition
- •A family history of congenital or hereditary immunodeficiency.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
- •Major congenital defects or any chronic illness.
- •History of any neurologic disorders or seizures.
- •Acute disease and/or fever at the time of enrolment.
- •Administration of immunoglobulins and/ or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
- •Contraindications to any co-administered vaccine.
- •Any medical condition that would contraindicate the initiation of routine immunization outside a clinical trial context.
- •Additional exclusion criteria for subjects in Cohort 2:
- •Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b with the exception of vaccines where the first dose should be given within the first two weeks of life according to the national recommendations (for example Bacillus Calmette-Guérin [BCG] and hepatitis B vaccination).
研究者
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