EUCTR2007-001707-38-CZ进行中（未招募）不适用
A phase IIIb, open, controlled study to evaluate the immunogenicity, and safety of 7PCV Prevenar vaccine in pre-term infants
niversity Hospital0 个研究点开始时间: 2007年7月12日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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 between, and including 10-14 weeks of age at the time of first vaccination·
- •Subjects for whom 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).
- •Written informed consent obtained from the parent or guardian of the subject.·
- •Born after a gestation period between 25 and 37 weeks in study group and between 38 and 42 weeks in control group.
- •Birth weight in study group more than 500g and in control group more than 2500g.
- •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
- •Usee of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the entire study period for each age-group.
- •Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before and ending one month after each dose of vaccine(s).
- •Previous vaccination against S. pneumoniae.
- •History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including diphtheria toxoid.
- •History of seizures or neurological disease.
- •Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea or mild upper respiratory infections with or without low-grade fever, i.e oral/axillary/tympanic temperature <37.5°C / rectal temperature <38.0°C).·
- •Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing required).
- •A family history of congenital or hereditary immunodeficiency.·
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the entire study period.
研究者
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