EUCTR2009-011587-11-GB进行中（未招募）1 期
INVESTIGATING THE CLINICAL USE OF 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE (PREVENAR)IN CHILDHOOD ACUTE LYMPHOBLASTIC LEUKAEMIA - PCV13 in A
niversity Hospital Southampton NHS Foundation Trust0 个研究点目标入组 118 人开始时间: 2010年10月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 118
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
入选标准
- •i)Age 2 to 18 years (inclusive)
- •ii)ALL confirmed by immunophenotyping at diagnosis
- •iii)Currently receiving maintenance therapy as per UKALL 2003 treatment protocol, or treatment as per UKALL 2003 protocol (iincluding interim guidelines) completed within last 6 months
- •iv)Informed consent of parent/guardian (+/- patient)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 120
- •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
- •i)Concomitant acquired or congenital immunodeficiency
- •ii)Concomitant immunosuppressive medication within previous 3 months, other than maintenance chemotherapy as per UKALL 2003 protocol
- •iii)Previous severe or anaphylactic reaction to PCV
- •iv)Previous severe or anaphylactic reaction to diphtheria toxoid
- •v) Previous immunisation with PCV13
- •v)Children with a contraindication to receipt of any vaccine or a specific vaccine as stated in the Department of Health Green Book on immunization (DOH, 2006)
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