EUCTR2004-001823-39-SE进行中（未招募）不适用
An open, randomized, controlled, phase II study to evaluate the safety and immunogenicity of GlaxoSmithKline Biologicals’ 11-valent pneumococcal conjugate vaccine, when administered intramuscularly as a 3, 5, 12 month vaccination schedule, as part of a staggered vaccination schedule - 11PN-PD-DIT-010
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
- 150
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 who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study.
- •A male or female between, and including, 8 and 12 weeks (56-90 days) of age at the time of enrollment.
- •Written informed consent obtained from the parents 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 between 36 and 42 weeks.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •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.
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. (For corticosteroids, this will mean prednisone, or equivalent, ? 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
- •Planned administration/ administration of a licensed vaccine not foreseen by the study protocol during the period starting from 30 days before the first dose of vaccine(s) and ending 30 days after the last dose.
- •Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, meningococcal serogroup C disease and/or S. pneumoniae.
- •History of or intercurrent diphtheria, tetanus, pertussis, hepatitis B, polio, Haemophilus influenzae type b disease, meningococcal serogroup C disease and/or invasive pneumococcal disease.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required).
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- •A family history of congenital or hereditary immunodeficiency.
- •History of allergic disease or reactions likely to be exacerbated by any component of the study vaccines.
- •Major congenital defects or serious chronic illness.
- •History of any neurologic disorders or seizures.
- •Acute disease at the time of enrolment: study entry should be postponed until the illness has improved. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. Study vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e., oral temperature < 37.5°C / axillary temperature < 37.5°C / rectal temperature < 38°C).
- •Other conditions that in the opinion of the investigator may potentially interfere with interpretation of study outcomes; these conditions must be recorded on a specific log sheet.
研究者
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