NCT00169728已完成3 期
Immunogenicity of the DTaP-IPV-HBV/Hib Combination Vaccine Infanrix Hexa and the Heptavalent Pneumococcal Conjugate Vaccine Prevenar in Pediatric Recipients of Allogeneic Haematopoietic Stem Cell Transplantation
Heinrich-Heine University, Duesseldorf13 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2003年9月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 13
- 主要终点
- serologic response at 1 months following primary three dose vaccination series
研究概览
简要总结
The purpose of this study is to determine the immunogenicity and tolerability of the DTaP-IPV-HBV/Hib combination vaccine Infanrix hexa and the heptavalent pneumococcal conjugate vaccine Prevenar in pediatric recipients of allogeneic haematopoietic stem cell transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pediatric recipient of allogeneic haematopoietic stem cell transplantation
- •complete remission of underlying malignant disease (if applicable)
- •stable haematopoietic engraftment
- •Lansky-/Karnofsky-score >= 60%
排除标准
- •primary immunodeficiency
- •hepatitis B or C, HIV infection
- •application of radio-/ chemotherapy following stem cell transplantation
- •extended chronic graft-versus-host disease (Karnofsky-scale < 60%)
- •coagulopathy
- •known allergy/hypersensitivity towards ingredients of study vaccines
- •seizure disorder, progressive neurologic disease
结局指标
主要结局
serologic response at 1 months following primary three dose vaccination series
时间窗: first month
次要结局
- serologic response at 1 months following booster immunization(first month)
- tolerability of primary and booster vaccination(at least monthly)
- identification of factors influencing immunogenicity and tolerability of study vaccines(at least monthly)
研究者
研究点 (13)
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